id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
10,782 |
PROVERA®
(medroxyprogesterone acetate tablets, USP)
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND
PROBABLE DEMENTIA FOR ESTROGEN PLUS ... | custom-source | 2025-02-12T13:43:46.784049 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011839s079s080lbl.pdf', 'application_number': 11839, 'submission_type': 'SUPPL ', 'submission_number': 79} |
10,784 |
SOLU-MEDROL® (methylprednisolone sodium succinate for injection, USP)
The formulations containing benzyl alcohol should not be used in neonates.
For Intravenous or Intramuscular Administration
DESCRIPTION
SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains ... | custom-source | 2025-02-12T13:43:46.861299 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011856s103s104lbl.pdf', 'application_number': 11856, 'submission_type': 'SUPPL ', 'submission_number': 104} |
10,785 |
NDA 11-870/S-040
Page 3
DIURIL®
(CHLOROTHIAZIDE) ORAL SUSPENSION
DESCRIPTION
DIURIL* (Chlorothiazide) is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine
7-sulfonamide 1... | custom-source | 2025-02-12T13:43:46.915519 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011870s040lbl.pdf', 'application_number': 11870, 'submission_type': 'SUPPL ', 'submission_number': 40} |
10,783 |
PROVERA®
(medroxyprogesterone acetate tablets, USP)
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND
PROBABLE DEMENTIA FOR ESTROGEN PLUS ... | custom-source | 2025-02-12T13:43:47.015605 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011839s079s080lbl.pdf', 'application_number': 11839, 'submission_type': 'SUPPL ', 'submission_number': 80} |
10,786 | 1
[Note: Below is the agreed upon labeling. Double underline font denotes additions to the
labeling, and strike-through font denotes deletions from the labeling.]
69-5985-00-1.1
NARDIL®
(Phenelzine Sulfate Tablets, USP)
DESCRIPTION
NARDIL® (phenelzine sulfate) is a potent inhibitor of monoamine oxidase (MAO).
Phenelz... | custom-source | 2025-02-12T13:43:47.133082 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/11909slr033_nardil_lbl.pdf', 'application_number': 11909, 'submission_type': 'SUPPL ', 'submission_number': 33} |
10,787 | NARDIL®
(Phenelzine Sulfate Tablets, USP)
Suicidality in Children and Adolescents
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in
short-term studies in children and adolescents with Major Depressive Disorder (MDD)
and other psychiatric disorders. Anyone considering the us... | custom-source | 2025-02-12T13:43:47.250256 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011909s036lbl.pdf', 'application_number': 11909, 'submission_type': 'SUPPL ', 'submission_number': 36} |
10,788 | 1
ATTACHMENT
FINAL LABELING
MARPLAN®
brand of isocarboxazid
TABLETS
DESCRIPTION
Marplan (isocarboxazid), a monoamine oxidase inhibitor, is available for oral administration in 10-mg
tablets. Each tablet also contains gelatin, lactose, magnesium stearate, corn starch, talc, FD&C Red
No. 3 and FD&C Yellow No. 6. Ch... | custom-source | 2025-02-12T13:43:47.336350 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/11961lbl.pdf', 'application_number': 11961, 'submission_type': 'SUPPL ', 'submission_number': 17} |
10,789 | NDA 11-963/S-034
Page 3
Phospholine Iodide®
(echothiophate iodide for ophthalmic solution)
Rx only
DESCRIPTION
Chemical name: (2-mercaptoethyl) trimethylammonium iodide O,O-diethyl phosphorothioate
Structural formula
[Structure]
Echothiophate iodide for ophthalmic solution occurs as a white, crys... | custom-source | 2025-02-12T13:43:47.407793 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011963s034lbl.pdf', 'application_number': 11963, 'submission_type': 'SUPPL ', 'submission_number': 34} |
10,790 |
COGENTIN®
(benztropine mesylate injection)
Rx Only
DESCRIPTION
Benztropine mesylate is a synthetic compound containing structural features found in
atropine and diphenhydramine. ... | custom-source | 2025-02-12T13:43:47.409442 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s027lbl.pdf', 'application_number': 12015, 'submission_type': 'SUPPL ', 'submission_number': 27} |
10,792 |
Cyclophosphamide for Injection, USP
Cyclophosphamide Tablets, USP
DESCRIPTION
Cyclophosphamide for Injection, USP is a sterile white powder containing
cyclophosphamide monohydrate. Cyclophosphamide Tablets, USP are for oral use and
contain 25 mg or 50 mg cyclophosphamide (anhydrous). Inactive ingredi... | custom-source | 2025-02-12T13:43:47.627412 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012141s089lbl.pdf', 'application_number': 12141, 'submission_type': 'SUPPL ', 'submission_number': 89} |
10,793 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:43:47.810624 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012141s090,012142s112lbl.pdf', 'application_number': 12141, 'submission_type': 'SUPPL ', 'submission_number': 90} |
10,791 |
1
KENALOG®-10 INJECTION
triamcinolone acetonide injectable suspension, USP
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
For Intra-articular or Intralesional Use Only
NOT FOR INTRAVENOUS, INTRAMUSCULAR, INTRAOCULAR, EPIDURAL, OR
INTRATHECAL USE
DESCRIPTION
Kenalog®-10 Injection (triamcinolone acetonid... | custom-source | 2025-02-12T13:43:47.928168 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012041s038lbl.pdf', 'application_number': 12041, 'submission_type': 'SUPPL ', 'submission_number': 38} |
10,795 | NDA 12-151/S-062
Page 2
Aldactone®
spironolactone tablets, USP
WARNING
Aldactone has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions).
Aldactone should be used only in those conditions described under Indications and Usage.
Unnecessary use of this drug should be avoided.
... | custom-source | 2025-02-12T13:43:47.981408 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012151s062lbl.pdf', 'application_number': 12151, 'submission_type': 'SUPPL ', 'submission_number': 62} |
10,794 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:43:47.986362 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012141s090,012142s112lbl.pdf', 'application_number': 12142, 'submission_type': 'SUPPL ', 'submission_number': 112} |
10,796 |
Aldactone®
spironolactone tablets, USP
WARNING
ALDACTONE has been shown to be a tumorigen in chronic toxicity studies in rats (see
Precautions). ALDACTONE should be used only in those conditions described under
Indications and Usage. Unnecessary use of this drug should be avoided.
DESCRIPTION ... | custom-source | 2025-02-12T13:43:48.202050 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012151s071lbl.pdf', 'application_number': 12151, 'submission_type': 'SUPPL ', 'submission_number': 71} |
10,797 | Aldactone®
spironolactone tablets, USP
WARNING
ALDACTONE has been shown to be a tumorigen in chronic toxicity studies in rats (see
Precautions). ALDACTONE should be used only in those conditions described under
Indications and Usage. Unnecessary use of this drug should be avoided.
DESCRIPTION
ALDACTONE oral tabl... | custom-source | 2025-02-12T13:43:48.280282 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012151s072lbl.pdf', 'application_number': 12151, 'submission_type': 'SUPPL ', 'submission_number': 72} |
10,798 |
... | custom-source | 2025-02-12T13:43:48.430260 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012209s040lbl.pdf', 'application_number': 12209, 'submission_type': 'SUPPL ', 'submission_number': 40} |
10,799 | NDC 0409-1036-30
30 mL Single-Dose Vial
Carbocaine
®
mepivacaine hydrochloride
injection, USP
1%
STERILE INJECTION
NDC 0409-1036-30
C-400
30 mL Single-Dose Vial
Carbocaine
®
mepivacaine hydrochloride
injection, USP
1%
STERILE INJECTION
For PERIPHERAL
NERVE BLOCK,
CAUDAL, EPIDURAL,
and INFILTRATION
ANESTHESIA
Not for s... | custom-source | 2025-02-12T13:43:48.507896 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012250s028lbl.pdf', 'application_number': 12250, 'submission_type': 'SUPPL ', 'submission_number': 28} |
10,800 | Attachment 1
Page 1
Class Suicidality Labeling Language for Antidepressants
[This section should be located at the beginning of the package insert with bolded font and
enclosed in a black box]
[Insert established name]
Suicidality in Children and Adolescents
Antidepressants increased the risk of ... | custom-source | 2025-02-12T13:43:48.559700 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12342s055lbl.pdf', 'application_number': 12342, 'submission_type': 'SUPPL ', 'submission_number': 55} |
10,801 |
PRESCRIBING INFORMATION
PARNATE®
(tranylcypromine sulfate)
tablets 10 mg
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and
behavior (suicidality) in children, adolescents, and young adults in short-term studies of
major depre... | custom-source | 2025-02-12T13:43:48.750886 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012342s061lbl.pdf', 'application_number': 12342, 'submission_type': 'SUPPL ', 'submission_number': 61} |
10,802 |
SOMA® COMPOUND
CIV
(carisoprodol and aspirin tablets, USP) for Oral Use
DESCRIPTION
Soma Compound (carisoprodol and aspirin tablets, USP) is a fixed-dose combination product
containing the following two products:
•
200 mg of carisoprodol, a centrally-acting muscle relaxant
•
325 m... | custom-source | 2025-02-12T13:43:48.812377 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012365s039lbl.pdf', 'application_number': 12365, 'submission_type': 'SUPPL ', 'submission_number': 39} |
10,803 |
SOMA® COMPOUND with CODEINE
(carisoprodol, aspirin, and codeine phosphate, USP) tablets for oral use
Warning: May be habit-forming. CIII
DESCRIPTION
Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate tablets, USP) is a
fixed-dose combination product containi... | custom-source | 2025-02-12T13:43:48.882824 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012366s031lbl.pdf', 'application_number': 12366, 'submission_type': 'SUPPL ', 'submission_number': 31} |
10,805 |
SOMA® COMPOUND with CODEINE
CIII
(carisoprodol, aspirin and codeine phosphate, USP) Tablets for Oral Use
Warning: May be habit-forming.
DESCRIPTION
Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate tablets, USP) is a
fixed-dose combination product containing the foll... | custom-source | 2025-02-12T13:43:49.060956 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012366s033lbl.pdf', 'application_number': 12366, 'submission_type': 'SUPPL ', 'submission_number': 33} |
10,804 |
SOMA® COMPOUND with CODEINE
(carisoprodol, aspirin and codeine phosphate, USP) tablets for oral use
Warning: May be habit-forming. CIII
DESCRIPTION
Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate tablets,
USP) is a fixed-dose combination product containing the f... | custom-source | 2025-02-12T13:43:49.127181 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012366s032lbl.pdf', 'application_number': 12366, 'submission_type': 'SUPPL ', 'submission_number': 32} |
10,807 |
Zarontin®
(Ethosuximide Capsules, USP)
DESCRIPTION
Zarontin (ethosuximide) is an anticonvulsant succinimide, chemically designated as alpha-ethyl-alpha
methyl-succinimide, with the following structural f... | custom-source | 2025-02-12T13:43:49.257811 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012380s032lbl.pdf', 'application_number': 12380, 'submission_type': 'SUPPL ', 'submission_number': 32} |
10,806 |
SOMA® COMPOUND with CODEINE
CIII
(carisoprodol, aspirin and codeine phosphate, USP) Tablets for Oral Use
Warning: May be habit-forming.
WARNING: Death Related to Ultra-Rapid Metabolism of Codeine to Morphine
Respiratory depress... | custom-source | 2025-02-12T13:43:49.340369 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012366s034lbl.pdf', 'application_number': 12366, 'submission_type': 'SUPPL ', 'submission_number': 34} |
10,809 |
----------
... | custom-source | 2025-02-12T13:43:49.466761 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012427s026lbl.pdf', 'application_number': 12427, 'submission_type': 'SUPPL ', 'submission_number': 26} |
10,808 |
NDA 012380/S-034
FDA Approved Labeling Text dated 4/30/2012
Page 1
Zarontin®
(Ethosuximide Capsules, USP)
DESCRIPTION
Zarontin (ethosuximide) is an anticonvulsant succinimide, ch... | custom-source | 2025-02-12T13:43:49.473685 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012380s034lbl.pdf', 'application_number': 12380, 'submission_type': 'SUPPL ', 'submission_number': 34} |
10,811 |
1
PRESCRIBING INFORMATION
1
2
TABLOID®
3
brand Thioguanine
4
40-mg Scored Tablets
5
CAUTION
6
TABLOID brand Thioguanine is a potent drug. It should not be used unless a diagnosis
7
of acute nonlymphocytic leukemia has been adequately established and the responsible
8
physician is knowledgeable in ... | custom-source | 2025-02-12T13:43:49.686659 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12429slr021_tabloid_lbl.pdf', 'application_number': 12429, 'submission_type': 'SUPPL ', 'submission_number': 21} |
10,813 |
Depo-Provera®
medroxyprogesterone
acetate injectable
suspension, USP
DESCRIPTION
DEPO-PROVERA Sterile Aqueous Suspension contains medroxyprogesterone acetate,
which is a derivative of progesterone and is active by the parenteral and oral routes... | custom-source | 2025-02-12T13:43:49.725602 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012541s084lbl.pdf', 'application_number': 12541, 'submission_type': 'SUPPL ', 'submission_number': 84} |
10,810 | 1
PRESCRIBING INFORMATION
TABLOID® BRAND THIOGUANINE
40-mg Scored Tablets
CAUTION
TABLOID brand Thioguanine is a potent drug. It should not be used unless a diagnosis
of acute nonlymphocytic leukemia has been adequately established and the responsible
physician is knowledgeable in assessing response to chemotherapy.
DE... | custom-source | 2025-02-12T13:43:49.818820 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12429slr019_tabloid_lbl.pdf', 'application_number': 12429, 'submission_type': 'SUPPL ', 'submission_number': 19} |
10,812 |
1
PRESCRIBING INFORMATION
1
TABLOID®
2
brand Thioguanine
3
40-mg Scored Tablets
4
CAUTION
5
TABLOID brand Thioguanine is a potent drug. It should not be used unless a diagnosis
6
of acute nonlymphocytic leukemia has been adequately established and the responsible
7
physician is knowledgeable in assess... | custom-source | 2025-02-12T13:43:49.871236 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/12429s022lbl.pdf', 'application_number': 12429, 'submission_type': 'SUPPL ', 'submission_number': 22} |
10,814 | Page 1
Rev. November 2003
TENUATE® IV
(diethylpropion hydrochloride USP)
immediate-release
25 mg tablets
TENUATE® DOSPAN® IV
(diethylpropion hydrochloride USP)
controlled-release
75 mg tablets
DESCRIPTION
TENUATE® is available for oral administration in immediate-release tablets containing 25 mg
... | custom-source | 2025-02-12T13:43:49.905046 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11722s029,12546s032lbl.pdf', 'application_number': 12546, 'submission_type': 'SUPPL ', 'submission_number': 32} |
10,815 |
NDA 12-583/S-037
Page 3
[Company Logo]
OPHTHETIC®
(proparacaine HCl ophthalmic solution) 0.5%
DESCRIPTION
OPHTHETIC® (proparacaine HCl ophthalmic solution) 0.5% is a topical local anesthetic for
ophthalmic use.
Structural Formula:
[structure]
Chemical Name:
Benzoic acid, 3-amino-4-propoxy-,... | custom-source | 2025-02-12T13:43:49.967631 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12583s037lbl.pdf', 'application_number': 12583, 'submission_type': 'SUPPL ', 'submission_number': 28} |
10,816 |
Aldactazide®
spironolactone and
hydrochlorothiazide tablets
WARNING
Spironolactone, an ingredient of ALDACTAZIDE, has been shown to be a tumorigen in
chronic toxicity studies in rats (see Precautions). ALDACTAZIDE should be used only
in those conditions described under Indications an... | custom-source | 2025-02-12T13:43:50.078655 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012616s068lbl.pdf', 'application_number': 12616, 'submission_type': 'SUPPL ', 'submission_number': 68} |
10,817 |
Aldactazide®
spironolactone and
hydrochlorothiazide tablets
WARNING
Spironolactone, an ingredient of ALDACTAZIDE, has been shown to be a tumorigen in
chronic toxicity studies in rats (see Precautions). ALDACTAZIDE should be used only
in those conditions described under Indica... | custom-source | 2025-02-12T13:43:50.263511 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012616s073lbl.pdf', 'application_number': 12616, 'submission_type': 'SUPPL ', 'submission_number': 73} |
10,819 | SEARLE
Flagyl®
(metronidazole)
WARNING
Metronidazole has been shown to be carcinogenic in mice and rats. (See PRECAUTIONS.) Unnecessary
use of the drug should be avoided. Its use should be reserved for the conditions described in the
Indications and Usage section below.
DESCRIPTION
Flagyl (metronidazole) is an oral syn... | custom-source | 2025-02-12T13:43:50.301052 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12623slr058_flagyl_lbl.pdf', 'application_number': 12623, 'submission_type': 'SUPPL ', 'submission_number': 58} |
10,820 |
FLAGYL®
(metronidazole) tablets
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
FLAGYL® and other antibacterial drugs, FLAGYL® should be used only t... | custom-source | 2025-02-12T13:43:50.373870 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012623s065lbl.pdf', 'application_number': 12623, 'submission_type': 'SUPPL ', 'submission_number': 65} |
10,818 | Aldactazide®
spironolactone and
hydrochlorothiazide tablets
WARNING
Spironolactone, an ingredient of ALDACTAZIDE, has been shown to be a tumorigen in
chronic toxicity studies in rats (see Precautions). ALDACTAZIDE should be used only
in those conditions described under Indications and Usage. Unnecessary use of thi... | custom-source | 2025-02-12T13:43:50.439639 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s076lbl.pdf', 'application_number': 12616, 'submission_type': 'SUPPL ', 'submission_number': 76} |
10,822 | SYNALAR®
(fluocinolone acetonide)
Ointment 0.025%
Rx Only
DESCRIPTION
SYNALAR® (fluocinolone acetonide) Ointment 0.025% is intended for topical
administration. The active component is the corticosteroid fluocinolone acetonide,
which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-
dihydroxy-16,17... | custom-source | 2025-02-12T13:43:50.551148 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lbl.pdf', 'application_number': 12787, 'submission_type': 'SUPPL ', 'submission_number': 71} |
10,821 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
(
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
| custom-source | 2025-02-12T13:43:50.563124 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1997/012770s024lbl.pdf', 'application_number': 12770, 'submission_type': 'SUPPL ', 'submission_number': 24} |
10,824 |
Cordran® SP Cream
and
Cordran® Ointment
Flurandrenolide, USP
DESCRIPTION
Cordran® (flurandrenolide, USP) is a potent corticosteroid intended for topical use.
Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless.
Flurandrenolide is practically insoluble in... | custom-source | 2025-02-12T13:43:50.736947 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012806s037lbl.pdf', 'application_number': 12806, 'submission_type': 'SUPPL ', 'submission_number': 37} |
10,823 |
s
truc
tura
l
for
m
ula
6<1$/$5p
ȵXRFLQRORQHDFHWRQLGH
&UHDP
for initiation of therapy in inflammatory dermatoses.
Rx Only
DESCRIPTION
SYNALAR® (fluocinolone acetonide) Cream 0.025% is intended for topical
administration. The active component is the corticosteroid fluocino... | custom-source | 2025-02-12T13:43:50.767358 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lblrev.pdf', 'application_number': 12787, 'submission_type': 'SUPPL ', 'submission_number': 71} |
10,825 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
| custom-source | 2025-02-12T13:43:50.817177 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/012892Orig1s015s016lbl.pdf', 'application_number': 12892, 'submission_type': 'SUPPL ', 'submission_number': 15} |
10,826 |
Novartis
Metopirone®
metyrapone USP
Capsules
Diagnostic Test of Pituitary
Adrenocorticotropic Function
Prescribing Information
DESCRIPTION
Metopirone, metyrapone USP, is an inhibitor of endogenous adrenal corticosteroid synthesis, available
as 250-mg capsules for oral administration. Its che... | custom-source | 2025-02-12T13:43:50.881618 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012911s026lbl.pdf', 'application_number': 12911, 'submission_type': 'SUPPL ', 'submission_number': 26} |
10,827 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
... | custom-source | 2025-02-12T13:43:50.980867 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012911Orig1s033lbl.pdf', 'application_number': 12911, 'submission_type': 'SUPPL ', 'submission_number': 33} |
10,828 | NDA 12-945/S-037 & S-038
Page 3
DIAMOX® SEQUELS® (Acetazolamide Extended-Release Capsules)
Rx only
DESCRIPTION
DIAMOX SEQUELS (Acetazolamide Extended-Release Capsules) are an inhibitor of the enzyme
carbonic anhydrase.
DIAMOX is a white to faintly yellowish white crystalline, odorless powder, weakly aci... | custom-source | 2025-02-12T13:43:51.058056 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12945s037,038lbl.pdf', 'application_number': 12945, 'submission_type': 'SUPPL ', 'submission_number': 37} |
10,830 | Norflex (orphenadrine citrate) Injection
[Graceway Pharmaceuticals, LLC]
Effective Date: 10/01/2007
DESCRIPTION:
Orphenadrine citrate is the citrate salt of orphenadrine (2-dimethylaminoethyl 2-
methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter
taste. It is practically od... | custom-source | 2025-02-12T13:43:51.095565 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013055s021lbl.pdf', 'application_number': 13055, 'submission_type': 'SUPPL ', 'submission_number': 21} |
10,829 | Trecator
(ethionamide tablets, USP)
Tablets
only
DESCRIPTION
Trecator (ethionamide tablets, USP) is used in the treatment of tuberculosis. The chemical name for
ethionamide is 2-ethylthioisonicotinamide with the following structural formula:
C8H10N2S
M.W. 166.24
Ethionamide is a yellow crystalline, nonhyg... | custom-source | 2025-02-12T13:43:51.152818 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13026s022,023lbl.pdf', 'application_number': 13026, 'submission_type': 'SUPPL ', 'submission_number': 22} |
10,832 |
Company Logo
VALIUM®
brand of
diazepam
TABLETS
Rx Only
DESCRIPTION
Valium (diazepam) is a benzodiazepine derivative. The chemical name of
diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin
2-one. It is a colorless to light yellow crystalline compound, insoluble in
water... | custom-source | 2025-02-12T13:43:51.303253 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013263s083lbl.pdf', 'application_number': 13263, 'submission_type': 'SUPPL ', 'submission_number': 83} |
10,836 |
NDA 014134/S-022
FDA Approved Labeling Text dated September 8, 2010
PROTOPAM Chloride (pralidoxime chloride) for Injection
Rx only
DESCRIPTION
Chemical name: 2-formyl-1-methylpyridinium chloride oxime. Available in the United
States as PROTOPAM Chloride for Injection (PROTOPAM), pra... | custom-source | 2025-02-12T13:43:51.395433 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/014134s022lbl.pdf', 'application_number': 14134, 'submission_type': 'SUPPL ', 'submission_number': 22} |
10,831 | NDA 13-217/S-036
Page 3
SKELAXIN® (Metaxalone)
DESCRIPTION
SKELAXIN® (metaxalone) has the following chemical structure and name:
5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone
SKELAXIN (metaxalone) is available as a 400 mg round, pale rose tablet and an 800 mg oval, pink
scored tablet... | custom-source | 2025-02-12T13:43:51.448120 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/13217s036lbl.pdf', 'application_number': 13217, 'submission_type': 'SUPPL ', 'submission_number': 36} |
10,837 | NDA 14-214/S-053, S-055, S-056
Page 7
NSW-6 I (O)
NegGram ®
Caplets2
NALIDIXIC ACID, USP
To reduce the development of drug-resistant bacteria and maintain the effectiveness of NegGram (nalidixic acid,
USP) and other antibacterial drugs, NegGram should be used only to treat or prevent infections that are proven or stron... | custom-source | 2025-02-12T13:43:51.751379 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14214s053,055,056lbl.pdf', 'application_number': 14214, 'submission_type': 'SUPPL ', 'submission_number': 55} |
10,838 | NegGram® Caplets
(nalidixic acid, USP)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of NegGram
(nalidixic acid, USP) and other antibacterial drugs, NegGram should be used only to treat or
prevent infections that are proven or strongly suspected to be caused by bacteria.
D... | custom-source | 2025-02-12T13:43:51.864152 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014214s057lbl.pdf', 'application_number': 14214, 'submission_type': 'SUPPL ', 'submission_number': 57} |
10,839 |
company logo
CELESTONE SYRUP
PAGE 1
NDA 14-215/S-009, 015
CELESTONE®
betamethasone syrup, USP
DESCRIPTION
CELESTONE Syrup, for oral administration, contains 0.6 mg betamethasone in each 5 mL. The
inactive ingredients for CELESTONE Syrup include: alcohol (less than 1%), citric ... | custom-source | 2025-02-12T13:43:52.079576 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014215s009s015lbl.pdf', 'application_number': 14215, 'submission_type': 'SUPPL ', 'submission_number': 9} |
10,840 |
company logo
CELESTONE SYRUP
PAGE 1
NDA 14-215/S-009, 015
CELESTONE®
betamethasone syrup, USP
DESCRIPTION
CELESTONE Syrup, for oral administration, contains 0.6 mg betamethasone in each 5 mL. The
inactive ingredients for CELESTONE Syrup include: alcohol (less than 1%), citric ... | custom-source | 2025-02-12T13:43:52.286927 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014215s009s015lbl.pdf', 'application_number': 14215, 'submission_type': 'SUPPL ', 'submission_number': 15} |
10,833 | NDA 13-684/S-092, 16-677/S-139, 16-678/S-100, 16-679/S-099, 16-682/S-100,
16-683/S-096, 16-687/S-097, 16-689/S-100, 16-692/S-091, 16-693/S-091,
16-695/S-093, 16-696/S-094, 16-697/S-093, 17-378/S-063, 17-385/S-055,
17-390/S-060, 17-438/S-059, 17-451/S-058, 17-484/S-062, 17-634/S-065,
17-648/S-065, 18-008/S-065, 1... | custom-source | 2025-02-12T13:43:52.290386 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf', 'application_number': 13684, 'submission_type': 'SUPPL ', 'submission_number': 92} |
10,841 |
1
Rev. February 2006
NORPRAMIN®
(desipramine hydrochloride tablets USP)
Suicidality in Children and Adolescents
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-
term studies in children and adolescents with Major Depressive Disorder (MDD) and other
psychiatric d... | custom-source | 2025-02-12T13:43:52.582847 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014399s063lbl.pdf', 'application_number': 14399, 'submission_type': 'SUPPL ', 'submission_number': 63} |
10,842 |
NORPRAMIN®
(desipramine hydrochloride tablets USP)
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior
(suicidality) in children, adolescents, and young adults in short-term studies of major
depressive dis... | custom-source | 2025-02-12T13:43:52.586033 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014399s065lbl.pdf', 'application_number': 14399, 'submission_type': 'SUPPL ', 'submission_number': 65} |
10,844 |
CELESTONE® SOLUSPAN®
(betamethasone sodium phosphate
and betamethasone acetate) Injectable Suspension, USP
30 mg/5 mL (6 mg/mL)
DESCRIPTION CELESTONE® SOLUSPAN® Injectable Suspension is a sterile aqueous
suspension containing 3 mg per millili... | custom-source | 2025-02-12T13:43:52.659814 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/014602s059lbl.pdf', 'application_number': 14602, 'submission_type': 'SUPPL ', 'submission_number': 59} |
10,846 | NDAs 14-685/S-028
Page 3
NORTRIPTYLINE HYDROCHLORIDE ORAL SOLUTION, USP
Rx only
DESCRIPTION
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior
(suicidality) in children, adolescents, and young adults in short-term studies of major... | custom-source | 2025-02-12T13:43:52.888672 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014685s028lbl.pdf', 'application_number': 14685, 'submission_type': 'SUPPL ', 'submission_number': 28} |
10,845 | Attachment 1
Page 1
Class Suicidality Labeling Language for Antidepressants
[This section should be located at the beginning of the package insert with bolded font and
enclosed in a black box]
[Insert established name]
Suicidality in Children and Adolescents
Antidepressants increased the risk of ... | custom-source | 2025-02-12T13:43:52.981131 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14685s026lbl.pdf', 'application_number': 14685, 'submission_type': 'SUPPL ', 'submission_number': 26} |
10,847 | 1
PRESCRIBING INFORMATION
1
ALKERAN®
2
(melphalan)
3
Tablets
4
5
WARNING
6
ALKERAN (melphalan) should be administered under the supervision of a qualified
7
physician experienced in the use of cancer chemotherapeutic agents. Severe bone marrow
8
suppression with resulting infection or bleeding may occur. Melphalan is l... | custom-source | 2025-02-12T13:43:53.036351 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/14691slr024_alkeran_lbl.pdf', 'application_number': 14691, 'submission_type': 'SUPPL ', 'submission_number': 24} |
10,843 |
NORPRAMIN®
(desipramine hydrochloride tablets USP)
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior
(suicidality) in children, adolescents, and young adults in short-term studies of major
depressive dis... | custom-source | 2025-02-12T13:43:53.115670 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014399s069lbl.pdf', 'application_number': 14399, 'submission_type': 'SUPPL ', 'submission_number': 69} |
10,849 |
DOPRAM Injection
(doxapram hydrochloride injection, USP)
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
Rx only
DESCRIPTION
DOPRAM Injection (doxapram hydrochloride injection, USP) is a clear, colorless, sterile,
non-pyrogenic, aqueous solution with pH 3.5 to 5, for intravenous administration.
Each 1 mL c... | custom-source | 2025-02-12T13:43:53.243890 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14879s044lbl.pdf', 'application_number': 14879, 'submission_type': 'SUPPL ', 'submission_number': 44} |
10,848 |
PRESCRIBING INFORMATION
ALKERAN®
(melphalan)
Tablets
WARNING
ALKERAN (melphalan) should be administered under the supervision of a qualified
physician experienced in the use of cancer chemotherapeutic agents. Severe bone marrow
suppression with resulting infection or bleeding may occur. Me... | custom-source | 2025-02-12T13:43:53.366437 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s030lbl.pdf', 'application_number': 14691, 'submission_type': 'SUPPL ', 'submission_number': 30} |
10,850 | 1
KENALOG®-40 INJECTION
triamcinolone acetonide injectable suspension, USP
NOT FOR USE IN ---- ------------- NEONATES
CONTAINS BENZYL ALCOHOL
For Intramuscular or Intra-articular Use
NOT FOR INTRAVENOUS,----- INTRADERMAL, OR INTRAOCULAR USE
DESCRIPTION
Kenalog®-40 Injection (triamcinolone acetonide injectable ... | custom-source | 2025-02-12T13:43:53.634285 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014901s034lbl.pdf', 'application_number': 14901, 'submission_type': 'SUPPL ', 'submission_number': 34} |
10,851 |
NDA 12-041/S-036
NDA 14-901/S-037
Page 4
KENALOG®-10 INJECTION
triamcinolone acetonide injectable suspension, USP
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
For Intra-articular or Intralesional Use
NOT FOR INTRAVENOUS, INTRAMUSCULAR, OR INTRAOCULAR USE
DESCRIPTION ... | custom-source | 2025-02-12T13:43:53.819132 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012041s036,014901s037lbl.pdf', 'application_number': 14901, 'submission_type': 'SUPPL ', 'submission_number': 37} |
10,852 | 1
KENALOG-40 INJECTION
(triamcinolone acetonide injectable suspension, USP)
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
For Intramuscular or Intra-articular Use Only
NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL,
OR INTRATHECAL USE
DESCRIPTION
Kenalog-40 Injection (triamcinolone acetonide injec... | custom-source | 2025-02-12T13:43:53.826896 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014901s042lbledt.pdf', 'application_number': 14901, 'submission_type': 'SUPPL ', 'submission_number': 42} |
10,853 |
Mefenamic Acid Capsules, USP
250 mg
Rx only
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND
GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious
cardiovascular thr... | custom-source | 2025-02-12T13:43:53.870770 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015034s044lbl.pdf', 'application_number': 15034, 'submission_type': 'SUPPL ', 'submission_number': 44} |
10,854 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
| custom-source | 2025-02-12T13:43:53.964347 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf', 'application_number': 15193, 'submission_type': 'SUPPL ', 'submission_number': 18} |
10,855 | NDA 15-197/S-036, 037, 038, 039
Page 3
AMICAR Injection
AMICAR Syrup
AMICAR Tablets
(aminocaproic acid)
Rx only
DESCRIPTION
AMICAR (aminocaproic acid) is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis.
Its chemical structure is:
H2C(CH2)3CH2COOH
│
NH2
C6H13NO2
MW 131.17
... | custom-source | 2025-02-12T13:43:54.205481 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf', 'application_number': 15197, 'submission_type': 'SUPPL ', 'submission_number': 38} |
10,856 |
NDA 15-230/S-035, NDA 15-197/S-043
Page 3
AMICAR®
(aminocaproic acid)
Oral Solution and Tablets
Rx only
DESCRIPTION
AMICAR (aminocaproic acid) is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis.
Its chemical structure is: Chemical Structure
AMICAR is soluble i... | custom-source | 2025-02-12T13:43:54.469056 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf', 'application_number': 15197, 'submission_type': 'SUPPL ', 'submission_number': 43} |
10,857 |
NDA 15-230/S-035, NDA 15-197/S-043
Page 3
AMICAR®
(aminocaproic acid)
Oral Solution and Tablets
Rx only
DESCRIPTION
AMICAR (aminocaproic acid) is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis.
Its chemical structure is: Chemical Structure
AMICAR is soluble i... | custom-source | 2025-02-12T13:43:54.478301 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf', 'application_number': 15230, 'submission_type': 'SUPPL ', 'submission_number': 35} |
10,859 |
struct
ural
for
mu
la
... | custom-source | 2025-02-12T13:43:54.535585 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/015296s064lbl.pdf', 'application_number': 15296, 'submission_type': 'SUPPL ', 'submission_number': 64} |
10,858 |
NDA 15-230/S-037
Page 3
AMICAR®
(aminocaproic acid)
Oral Solution and Tablets
Rx only
DESCRIPTION
AMICAR (aminocaproic acid) is 6-aminohexanoic acid, which acts as an inhibitor of
fibrinolysis.
Its chemical structure is: C hemical Sructure
AMICAR is soluble in water, acid, and alkaline solut... | custom-source | 2025-02-12T13:43:54.610176 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015230s037lbl.pdf', 'application_number': 15230, 'submission_type': 'SUPPL ', 'submission_number': 37} |
10,861 |
1
HALDOL®
BRAND OF
HALOPERIDOL
INJECTION
(FOR IMMEDIATE RELEASE)
Rx only
DESCRIPTION
Haloperidol is the first of the butyrophenone series of major antipsychotics. The
chemical
designation
is
4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-
4’-fluorobutyrophenone and it has the following structural formula:
... | custom-source | 2025-02-12T13:43:54.882721 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/015923s078,018701s053lbl.pdf', 'application_number': 15923, 'submission_type': 'SUPPL ', 'submission_number': 78} |
10,860 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
| custom-source | 2025-02-12T13:43:54.888085 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15539s52lbl.pdf', 'application_number': 15539, 'submission_type': 'SUPPL ', 'submission_number': 52} |
10,862 |
structural formula
HALDOL®
brand of
haloperidol injection
(For Immediate Release)
WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. Analys... | custom-source | 2025-02-12T13:43:54.952434 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s079lbl.pdf', 'application_number': 15923, 'submission_type': 'SUPPL ', 'submission_number': 79} |
10,866 |
HALDOL
brand of
haloperidol injection
(For Immediate Release)
WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with a... | custom-source | 2025-02-12T13:43:55.957400 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/015923s091lbl.pdf', 'application_number': 15923, 'submission_type': 'SUPPL ', 'submission_number': 91} |
10,863 |
HALDOL®
brand of
haloperidol injection
(For Immediate Release)
WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis:
Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. Anal... | custom-source | 2025-02-12T13:43:55.959857 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s082,018701s057lbl.pdf', 'application_number': 15923, 'submission_type': 'SUPPL ', 'submission_number': 82} |
10,864 |
HALDOL®
brand of
haloperidol injection
(For Immediate Release)
WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. Analyses of seventeen pla... | custom-source | 2025-02-12T13:43:55.992630 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015923s084lbl.pdf', 'application_number': 15923, 'submission_type': 'SUPPL ', 'submission_number': 84} |
10,865 |
structural formula
HALDOL®
BRAND OF
HALOPERIDOL INJECTION
(FOR IMMEDIATE RELEASE)
WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. Analyses o... | custom-source | 2025-02-12T13:43:56.138414 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s086,018701s063lbl.pdf', 'application_number': 15923, 'submission_type': 'SUPPL ', 'submission_number': 86} |
10,868 | NDA 16-023/S-039
NDA 18-101/S-014
Page 3
SYMMETREL®
(Amantadine Hydrochloride, USP)
Tablets and Syrup
Rx only
DESCRIPTION
SYMMETREL (Amantadine Hydrochloride, USP) is designated generically as amantadine
hydrochloride and chemically as 1-adamantanamine hydrochloride.
Amantadine hydroch... | custom-source | 2025-02-12T13:43:57.069866 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016023s039,018101s014lbl.pdf', 'application_number': 16023, 'submission_type': 'SUPPL ', 'submission_number': 39} |
10,870 | NDA 16-092/S-042
NDA 16-093/S-044
Page 3
TABLETS
EDECRIN®
(ETHACRYNIC ACID)
and
INTRAVENOUS
SODIUM EDECRIN®
(ETHACRYNATE SODIUM)
EDECRIN* (Ethacrynic Acid) is a potent diuretic which, if given in excessive amounts, may lead to
profound diuresis with water and electrolyte depletion. Therefore, careful med... | custom-source | 2025-02-12T13:43:57.070204 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16092s042,16093s044lbl.pdf', 'application_number': 16092, 'submission_type': 'SUPPL ', 'submission_number': 42} |
10,869 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlig... | custom-source | 2025-02-12T13:43:57.301399 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf', 'application_number': 16059, 'submission_type': 'SUPPL ', 'submission_number': 98} |
10,867 |
HALDOL
brand of
haloperidol injection
(For Immediate Release)
WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with... | custom-source | 2025-02-12T13:43:57.389277 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015923s094,018701s072lbl.pdf', 'application_number': 15923, 'submission_type': 'SUPPL ', 'submission_number': 94} |
10,872 | NDA 16-096/S-033
NDA 16-097/S-026
Page 3
CHEWABLE TABLETS AND SUSPENSION
MINTEZOL®
(Thiabendazole)
DESCRIPTION
MINTEZOL* (Thiabendazole) is an anthelmintic provided as 500 mg chewable tablets, and as a suspension,
containing 500 mg thiabendazole per 5 mL. The suspension also contains sorbic acid 0.1% added ... | custom-source | 2025-02-12T13:43:57.630708 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16096slr033,16097slr026_mintezol_lbl.pdf', 'application_number': 16097, 'submission_type': 'SUPPL ', 'submission_number': 26} |
10,871 | NDA 16-096/S-033
NDA 16-097/S-026
Page 3
CHEWABLE TABLETS AND SUSPENSION
MINTEZOL®
(Thiabendazole)
DESCRIPTION
MINTEZOL* (Thiabendazole) is an anthelmintic provided as 500 mg chewable tablets, and as a suspension,
containing 500 mg thiabendazole per 5 mL. The suspension also contains sorbic acid 0.1% added ... | custom-source | 2025-02-12T13:43:57.665371 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16096slr033,16097slr026_mintezol_lbl.pdf', 'application_number': 16096, 'submission_type': 'SUPPL ', 'submission_number': 33} |
10,874 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
--------------------------------------------------------------------------------------------------------
This is a representation of an electronic record that was signed electronically and
... | custom-source | 2025-02-12T13:43:57.771921 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16126s25lbl.pdf', 'application_number': 16126, 'submission_type': 'SUPPL ', 'submission_number': 25} |
10,873 | 1
TESLAC®
(testolactone tablets, USP)
DESCRIPTION
TESLAC (testolactone tablets, USP) is available for oral administration as tablets providing
50 mg testolactone per tablet. Testolactone is a synthetic antineoplastic agent that is structurally
distinct from the androgen steroid nucleus in possessing a six-membered lac... | custom-source | 2025-02-12T13:43:57.784968 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16118slr023_teslac_lbl.pdf', 'application_number': 16118, 'submission_type': 'SUPPL ', 'submission_number': 23} |
10,876 | company logo
Desferal®
deferoxamine mesylate for injection USP
Vials
Rx only
Prescribing Information
DESCRIPTION
Desferal, deferoxamine mesylate USP, is an iron-chelating agent, available in vials for intramuscular,
subcutaneous, and intravenous administration. Desferal is supplied as vials containing 500 mg an... | custom-source | 2025-02-12T13:43:57.888065 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016267s050lbl.pdf', 'application_number': 16267, 'submission_type': 'SUPPL ', 'submission_number': 50} |
10,875 |
NDA 16-267/S-045
Page 3
Desferal®
deferoxamine mesylate for injection USP
Vials
Rx only
Prescribing Information
DESCRIPTION
Desferal, deferoxamine mesylate USP, is an iron-chelating agent, available in vials for intramuscular,
subcutaneous, and intravenous ad... | custom-source | 2025-02-12T13:43:58.056239 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016267s045lbl.pdf', 'application_number': 16267, 'submission_type': 'SUPPL ', 'submission_number': 45} |
10,879 | NDA 16-295/S-037
Page 3
Rx only
HYDREA
(hydroxyurea capsules, USP)
DESCRIPTION
HYDREA® (hydroxyurea capsules, USP) is an antineoplastic agent, available for oral use as capsules
providing 500 mg hydroxyurea. Inactive ingredients: citric acid, colorants (D&C Yellow No. 10,
FD&C Blue No. 1, FD&C Red 40 an... | custom-source | 2025-02-12T13:43:58.313363 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16295slr037_hydrea_lbl.pdf', 'application_number': 16295, 'submission_type': 'SUPPL ', 'submission_number': 37} |
10,878 | NDA 16-295/S-036
Page 3
Rx only
DROXIA
(hydroxyurea capsules, USP)
DESCRIPTION
DROXIA® (hydroxyurea capsules, USP) is available for oral use as capsules providing 200 mg,
300 mg and 400 mg hydroxyurea. Inactive ingredients: citric acid, gelatin, lactose, magnesium
stearate... | custom-source | 2025-02-12T13:43:58.365921 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16295se2-036_droxia_lbl.pdf', 'application_number': 16295, 'submission_type': 'SUPPL ', 'submission_number': 36} |
10,877 |
LASIX®
(furosemide)
Tablets 20, 40, and 80 mg
WARNING
LASIX® (furosemide) is a potent diuretic which, if given in excessive amounts, can lead to a
profound diuresis with water an... | custom-source | 2025-02-12T13:43:58.446837 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016273s068lbl.pdf', 'application_number': 16273, 'submission_type': 'SUPPL ', 'submission_number': 68} |
10,880 | 1
Rx only
DROXIA®
(hydroxyurea capsules, USP)
WARNING
Treatment of patients with DROXIA may be complicated by severe, sometimes life-
threatening, adverse effects. DROXIA should be administered under the supervision of a
physician experienced in the use of this medication for the treatment of sickle cell
anemia.... | custom-source | 2025-02-12T13:43:58.595613 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf', 'application_number': 16295, 'submission_type': 'SUPPL ', 'submission_number': 41} |
10,881 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
The... | custom-source | 2025-02-12T13:43:58.752629 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s045lbl.pdf', 'application_number': 16295, 'submission_type': 'SUPPL ', 'submission_number': 45} |
10,882 | 1
MYAMBUTOL®
Ethambutol Hydrochloride
TABLETS
100 mg and 400 mg
DESCRIPTION
MYAMBUTOL ethambutol hydrochloride is an oral chemotherapeutic agent which is
specifically effective against actively growing microorganisms of the genus Mycobacterium,
including M. tuberculosis. The structural formula is:
(+)-2,2'(Ethylen... | custom-source | 2025-02-12T13:43:58.765052 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.pdf', 'application_number': 16320, 'submission_type': 'SUPPL ', 'submission_number': 57} |
10,884 |
______________________________________________________________________________________________
Myambutol® (Ethambutol HCl USP) Tablets, 100 mg & 400 mg
1.14.2.3 Final Labeling Text
1.14.2.3
Final Labeling Text
The final labeling for Ethambutol HCl tablets 100 & 40mg can be found belo... | custom-source | 2025-02-12T13:43:58.959915 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016320s066lbl.pdf', 'application_number': 16320, 'submission_type': 'SUPPL ', 'submission_number': 66} |
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