id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
11,088 | 17-892 S038 FDA approved labeling text 2.11.08
1
Halcion®
triazolam tablets, USP CIV
DESCRIPTION
HALCION Tablets contain triazolam, a triazolobenzodiazepine hypnotic agent.
Triazolam is a white crystalline powder, soluble in alcohol and poorly soluble in water. It has a molecular
weight of 343.21.
T... | custom-source | 2025-02-12T13:44:23.755115 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017892s038lbl.pdf', 'application_number': 17892, 'submission_type': 'SUPPL ', 'submission_number': 38} |
11,084 | 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
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:44:23.761139 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/017874s18s27lbl.pdf', 'application_number': 17874, 'submission_type': 'SUPPL ', 'submission_number': 27} |
11,089 | NDA 17-911/S-068
Page 3
TABLETS
CLINORIL®
(SULINDAC)
Cardiovascular Risk
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk may increase with
duration of use. Patients with cardiovascular disease or risk factor... | custom-source | 2025-02-12T13:44:23.996689 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017911s068lbl.pdf', 'application_number': 17911, 'submission_type': 'SUPPL ', 'submission_number': 68} |
11,090 | NDA 17-911/S-070
Page 3
TABLETS
CLINORIL®
(SULINDAC)
Cardiovascular Risk
•
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients
with cardiovascular disease or risk facto... | custom-source | 2025-02-12T13:44:24.473205 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017911s070lbl.pdf', 'application_number': 17911, 'submission_type': 'SUPPL ', 'submission_number': 70} |
11,092 | *
10159300
barcode
barcode
ORTHO-NOVUM® Tablets
(norethindrone/ethinyl estradiol)
and MODICON® Tablets
(norethindrone/ethinyl estradiol)
Patients should be counseled that this product does not
protect against HIV infection (AIDS) and other sexually
transmitted diseases.
barcode
barcode
COMBINATIO... | custom-source | 2025-02-12T13:44:24.479160 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf', 'application_number': 17919, 'submission_type': 'SUPPL ', 'submission_number': 89} |
11,091 |
company logo
TABLETS
CLINORIL®
(SULINDAC)
Cardiovascular Risk
•
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial
infarction, and stroke, which can be fatal. This r... | custom-source | 2025-02-12T13:44:24.566135 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017911s073lbl.pdf', 'application_number': 17911, 'submission_type': 'SUPPL ', 'submission_number': 73} |
11,096 | RETIN-A®
Cream Gel Liquid
(tretinoin)
For Topical Use Only
Prescribing Information
Description: RETIN-A Gel, Cream, and Liquid, containing tretinoin are used for the topical treatment of acne
vulgaris. RETIN-A Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two ... | custom-source | 2025-02-12T13:44:24.774516 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf', 'application_number': 17955, 'submission_type': 'SUPPL ', 'submission_number': 20} |
11,095 | RETIN-A®
Cream Gel Liquid
(tretinoin)
For Topical Use Only
Prescribing Information
Description: RETIN-A Gel, Cream, and Liquid, containing tretinoin are used for the topical treatment of acne
vulgaris. RETIN-A Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two ... | custom-source | 2025-02-12T13:44:24.995982 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf', 'application_number': 17955, 'submission_type': 'SUPPL ', 'submission_number': 19} |
11,094 |
DDAVP®
Nasal Spray
(desmopressin acetate)
Rx only
DESCRIPTION
DDAVP® Nasal Spray (desmopressin acetate) is a synthetic analogue of the natural pituitary
hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water
conservation. It is chemically defined as follows:
Mol. wt. 1183.3... | custom-source | 2025-02-12T13:44:25.046545 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017922s038,018938s027,019955s013lbl.pdf', 'application_number': 17922, 'submission_type': 'SUPPL ', 'submission_number': 38} |
11,093 | 1
ORTHO-NOVUM® Tablets (norethindrone/ethinyl estradiol)
and MODICON® Tablets (norethindrone/ethinyl estradiol)
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING
Cigarette smoking increases the risk of serious cardiovascular events from combination oral
contraceptive use. This risk increases with age, particu... | custom-source | 2025-02-12T13:44:25.159581 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,018985s063lbl.pdf', 'application_number': 17919, 'submission_type': 'SUPPL ', 'submission_number': 99} |
11,097 | NDA 17-962/S-063 & S-064
Package Insert
Page 1
T2003-25
89009903
PARLODEL®
SnapTabs®
(bromocriptine mesylate) tablets, USP
(bromocriptine mesylate) capsules, USP
Rx only
DESCRIPTION
Parlodel® (bromocriptine mesylate) is an ergot derivative with potent dopamine receptor agonist
activity. Ea... | custom-source | 2025-02-12T13:44:25.225153 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf', 'application_number': 17962, 'submission_type': 'SUPPL ', 'submission_number': 63} |
11,099 |
Lopressor®
metoprolol tartrate tablets, USP
metoprolol tartrate injection, USP
Rx only
Prescribing Information
DESCRIPTION
Lopressor, metoprolol tartrate USP, is a selective beta1-adrenoreceptor blocking agent, available
as 50- and 100-mg tablets for oral administration and in 5-mL ampuls for intraveno... | custom-source | 2025-02-12T13:44:25.478422 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017963s067lbl.pdf', 'application_number': 17963, 'submission_type': 'SUPPL ', 'submission_number': 67} |
11,098 |
company logo
Parlodel®
SnapTabs®
(bromocriptine mesylate) tablets, USP
(bromocriptine mesylate) capsules, USP
Rx only
Prescribing Information
DESCRIPTION
Parlodel® (bromocriptine mesylate) is an ergot derivative with potent dopamine receptor agonist
activity. Each Parlodel® (br... | custom-source | 2025-02-12T13:44:25.544551 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf', 'application_number': 17962, 'submission_type': 'SUPPL ', 'submission_number': 68} |
11,100 |
Lopressor®
metoprolol tartrate tablets, USP
Rx only
Prescribing Information
DESCRIPTION
Lopressor, metoprolol tartrate USP, is a selective beta1-adrenoreceptor blocking agent, available
as 50- and 100-mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-
(Isopropylamino)-3-[p-(2-methoxyethyl)p... | custom-source | 2025-02-12T13:44:25.672405 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017963s068lbl.pdf', 'application_number': 17963, 'submission_type': 'SUPPL ', 'submission_number': 68} |
11,101 | NDA 17-970/S-049
Page 3
Rev 05-02
SIC XXXXX-XX
WARNING - For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast
Cancer: Serious and life-threatening events associated with NOLVADEX in the risk reduction setting
(women at high risk for cancer and women with DCIS) incl... | custom-source | 2025-02-12T13:44:25.895449 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf', 'application_number': 17970, 'submission_type': 'SUPPL ', 'submission_number': 37} |
11,103 | NDA 17-970/S-048
Page 3
MEDICATION GUIDE
NOLVADEX (NOLE-vah-dex) Tablets
Generic name: tamoxifen (ta-MOX-I-fen)
Written for women who use NOLVADEX to lower their high chance of getting breast cancer or
who have ductal carcinoma in situ (DCIS)
This Medication Guide discusses only the use of NOLVADEX to... | custom-source | 2025-02-12T13:44:25.925713 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17970slr048_nolvadex_lbl.pdf', 'application_number': 17970, 'submission_type': 'SUPPL ', 'submission_number': 48} |
11,102 | T-10 10-28 one column.doc
PROFESSIONAL INFORMATION BROCHURE
T-10 10/28/98
SIC XXXXX-XX
DESCRIPTION
NOLVADEX_ (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are for oral
administration. NOLVADEX Tablets are available as:
10 mg Tablets. Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to... | custom-source | 2025-02-12T13:44:26.007336 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/17970.pdf', 'application_number': 17970, 'submission_type': 'SUPPL ', 'submission_number': 39} |
11,104 |
Rev 08-30-02
SIC XXXXX-XX
WARNING - For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk
for Breast Cancer: Serious and life-threatening events associated with NOLVADEX in the risk
reduction setting (women at high risk for cancer and women with DCIS) include uterine
malignancies, stroke and pulmonar... | custom-source | 2025-02-12T13:44:26.137780 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21109lbl,17970s50lbl.pdf', 'application_number': 17970, 'submission_type': 'SUPPL ', 'submission_number': 50} |
11,106 | 1
EL:L50
PRESCRIBING INFORMATION
ESKALITH
(lithium carbonate)
Capsules, 300 mg
ESKALITH CR
(lithium carbonate)
Controlled-Release
Tablets, 450 mg
WARNING
Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to
therapeutic levels. Facilities for prompt and accurate serum lithium de... | custom-source | 2025-02-12T13:44:26.328025 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16860slr074,18152slr020_eskalith_lbl.pdf', 'application_number': 17971, 'submission_type': 'SUPPL ', 'submission_number': 20} |
11,107 |
Hemabate®
carboprost tromethamine
injection, USP
DESCRIPTION
HEMABATE Sterile Solution, an oxytocic, contains the tromethamine salt of the (15S)
15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for
intramuscular injection.
Carboprost trometha... | custom-source | 2025-02-12T13:44:26.343681 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017989s019lbl.pdf', 'application_number': 17989, 'submission_type': 'SUPPL ', 'submission_number': 19} |
11,108 | PSORCON® E Emollient Ointment
(diflorasone diacetate ointment) 0.05%
Prescribing Information as of December 2001.
Not For Ophthalmic Use
DESCRIPTION
Each gram of Psorcon E Emollient Ointment contains 0.5 mg diflorasone diacetate in an ointment base.
Chemically, diflorasone diacetate is: 6α,9-difluoro - 11β,17,21 - trih... | custom-source | 2025-02-12T13:44:26.471041 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17994slr022_psorcon_lbl.pdf', 'application_number': 17994, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,105 | 1
Rev 04-15-04
NOLVADEX
(Tamoxifen Citrate)
TABLETS
WARNING - For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk
for Breast Cancer: Serious and life-threatening events associated with NOLVADEX in the risk
reduction setting (women at high risk for cancer and women with DCIS) include uter... | custom-source | 2025-02-12T13:44:26.653946 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17970s052lbl.pdf', 'application_number': 17970, 'submission_type': 'SUPPL ', 'submission_number': 52} |
11,110 | 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 | 2025-02-12T13:44:26.895236 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf', 'application_number': 18012, 'submission_type': 'SUPPL ', 'submission_number': 26} |
11,111 |
Pamelor™
(nortriptyline HCl) capsules USP
(nortriptyline HCl) oral solution USP
Rx only
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and
behavior (suicidality) in children, adolescents, and ... | custom-source | 2025-02-12T13:44:26.920542 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.pdf', 'application_number': 18012, 'submission_type': 'SUPPL ', 'submission_number': 29} |
11,113 | 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 | 2025-02-12T13:44:27.237772 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf', 'application_number': 18013, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,112 |
Pamelor™
(nortriptyline HCl) oral solution USP
Rx only
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo o... | custom-source | 2025-02-12T13:44:27.447949 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018012s030lbl.pdf', 'application_number': 18012, 'submission_type': 'SUPPL ', 'submission_number': 30} |
11,114 |
Pamelor™
(nortriptyline HCl) capsules USP
Rx only
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of... | custom-source | 2025-02-12T13:44:27.600910 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s062lbl.pdf', 'application_number': 18013, 'submission_type': 'SUPPL ', 'submission_number': 62} |
11,116 | Sodium Chloride Injection, USP
in VIAFLEX Plastic Container
Description
Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution
for fluid and electrolyte replenishment in single dose containers for
intravenous administration. It contains no antimicrobial agents.
The pH is 5.0 (4.5 to 7.0). Composition, ... | custom-source | 2025-02-12T13:44:27.962886 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018016s056lbl.pdf', 'application_number': 18016, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,115 |
Pamelor™
(nortriptyline HCl) capsules USP
Rx only
Suicidality and Antidepressant Drugs
Antidepressants increased the risk co... | custom-source | 2025-02-12T13:44:27.975823 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s063lbl.pdf', 'application_number': 18013, 'submission_type': 'SUPPL ', 'submission_number': 63} |
11,118 |
07-19-69-742
Baxter
Sodium Chloride Injection, USP
in AVIVA Plastic Container
DESCRIPTION
Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and
electrolyte replenishment in single dose containers for intravenous administration. It
contains no antimicrobial agents. The nominal p... | custom-source | 2025-02-12T13:44:28.529400 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016677s147,016693s096,018016s061lbl.pdf', 'application_number': 18016, 'submission_type': 'SUPPL ', 'submission_number': 61} |
11,119 |
Sodium Chloride Injection, USP
in AVIVA Plastic Container
DESCRIPTION
Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and
electrolyte replenishment in single dose containers for intravenous adm... | custom-source | 2025-02-12T13:44:28.767090 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf', 'application_number': 18016, 'submission_type': 'SUPPL ', 'submission_number': 62} |
11,109 | 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 | 2025-02-12T13:44:29.024777 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf', 'application_number': 18008, 'submission_type': 'SUPPL ', 'submission_number': 65} |
11,120 |
LITHOBID®
(Lithium Carbonate, USP) Slow-Release Tablets 300 mg
0990
9E Rev 5/2002
LITHOBID®
(Lithium Carbonate, USP) Slow-Release Tablets 300 mg
WARNING
Lithium toxicity is closely related to serum lithium levels, and can occur at doses close
to therapeutic levels. Facilities for prompt and acc... | custom-source | 2025-02-12T13:44:29.215153 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf', 'application_number': 18027, 'submission_type': 'SUPPL ', 'submission_number': 49} |
11,121 |
LITHOBID® (Lithium Carbonate, USP)
Extended-Release Tablets 300 mg
Rev month/year
Rx only
WARNING
Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels.
Facilities for prompt and accurate serum lithium determinations should be available... | custom-source | 2025-02-12T13:44:29.407094 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018027s056lbl.pdf', 'application_number': 18027, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,122 |
T2006-56
Ritalin® hydrochloride
methylphenidate hydrochloride
tablets USP
Ritalin-SR®
methylphenidate hydrochloride USP
sustained-release tablets
Rx only
Prescribing Information
DESCRIPTION
Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous... | custom-source | 2025-02-12T13:44:29.625774 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf', 'application_number': 18029, 'submission_type': 'SUPPL ', 'submission_number': 38} |
11,123 |
Novartis logo
Ritalin® hydrochloride
methylphenidate hydrochloride
tablets USP
Ritalin-SR®
methylphenidate hydrochloride USP
sustained-release tablets
Rx only
Prescribing Information
DESCRIPTION
Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system... | custom-source | 2025-02-12T13:44:30.007398 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018029s043lbl.pdf', 'application_number': 18029, 'submission_type': 'SUPPL ', 'submission_number': 43} |
11,124 |
company logo
Ritalin® hydrochloride
methylphenidate hydrochloride
tablets USP
Ritalin-SR® company logo
methylphenidate hydrochloride USP
sustained-release tablets company logo
Rx only
Prescribing Information
DESCRIPTION
Ritalin hydrochlori... | custom-source | 2025-02-12T13:44:30.259092 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s074,018029s044lbl.pdf', 'application_number': 18029, 'submission_type': 'SUPPL ', 'submission_number': 44} |
11,117 | 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 | 2025-02-12T13:44:30.411608 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf', 'application_number': 18016, 'submission_type': 'SUPPL ', 'submission_number': 57} |
11,126 | 1
INDERIDE®
(propranolol hydrochloride [Inderal®]
and hydrochlorothiazide)
Rx only
DESCRIPTION
Inderide Tablets for oral administration combine two antihypertensive agents: Inderal
(propranolol hydrochloride), a beta-adrenergic blocking agent, and hydrochlorothiazide, a
thiazide diuretic-antihypertensive. Inderide ... | custom-source | 2025-02-12T13:44:30.504399 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018031s035lbl.pdf', 'application_number': 18031, 'submission_type': 'SUPPL ', 'submission_number': 35} |
11,125 | Ritalin® hydrochloride
methylphenidate hydrochloride USP
tablets
Ritalin-SR®
methylphenidate hydrochloride USP
sustained-release tablets
Rx only
Prescribing Information
DESCRIPTION
Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS)
stimulant, available as tablets ... | custom-source | 2025-02-12T13:44:30.649016 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010187s080,018029s049,021284s027lbl.pdf', 'application_number': 18029, 'submission_type': 'SUPPL ', 'submission_number': 49} |
11,129 |
DRAXIMAGE® MDP-25
Kit for the Preparation of Technetium Tc 99m Medronate Injection
For Intravenous Use
DIAGNOSTIC – FOR SKELETAL IMAGING
DESCRIPTION
The kit consists of reaction vials which contain the sterile, non-pyrogenic, non-radioactive
ingredients necessary to produ... | custom-source | 2025-02-12T13:44:30.842927 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018035s032lbl.pdf', 'application_number': 18035, 'submission_type': 'SUPPL ', 'submission_number': 32} |
11,127 |
NDA 18031/S-036
Page 3
INDERIDE®
(propranolol hydrochloride [Inderal®]
and hydrochlorothiazide)
Rx only
DESCRIPTION
Inderide Tablets for oral administration combine two antihypertensive agents: Inderal
(propranolol hydrochloride), a beta-adr... | custom-source | 2025-02-12T13:44:30.843261 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018031s036lbl.pdf', 'application_number': 18031, 'submission_type': 'SUPPL ', 'submission_number': 36} |
11,128 |
INDERIDE®
(propranolol hydrochloride [Inderal®]
and hydrochlorothiazide)
Rx only
DESCRIPTION
Inderide Tablets for oral administration combine two antihypertensive agents: Inderal
(propranolol hydrochloride), a beta-adrenergic blocking agent, and hydrochlorothiazide, a
thiazide diuretic-antihyperten... | custom-source | 2025-02-12T13:44:30.933281 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018031s037s038lbl.pdf', 'application_number': 18031, 'submission_type': 'SUPPL ', 'submission_number': 38} |
11,130 | NDA 18-008/ S-066, 18-037/ S-066, 19-308/ S-023
Page 3
Baxter
Potassium Chloride in 5% Dextrose and Sodium Chloride Injection,
USP
in AVIVA Plastic Container
Description
Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic
solution for fluid and electrolyte repleni... | custom-source | 2025-02-12T13:44:31.068046 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018008s066,018037s066,019308s023lbl.pdf', 'application_number': 18037, 'submission_type': 'SUPPL ', 'submission_number': 66} |
11,132 | DESCRIPTION
Estramustine phosphate sodium, an antineoplastic agent, is an off-white powder
readily soluble in water. EMCYT Capsules are white and opaque, each containing
estramustine phosphate sodium as the disodium salt monohydrate equivalent to
140 mg estramustine phosphate, for oral administration. Each capsule also... | custom-source | 2025-02-12T13:44:31.229695 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18045slr021_emcyt_lbl.pdf', 'application_number': 18045, 'submission_type': 'SUPPL ', 'submission_number': 21} |
11,131 |
07-19-69-877
Baxter
Potassium Chloride in 5% Dextrose and Sodium
Chloride Injection, USP
in Plastic Container
VIAFLEX Plus Container
Description
Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP is a sterile,
nonpyrogenic solution for fluid and electrolyte replen... | custom-source | 2025-02-12T13:44:31.279523 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018008s070,018037s070,019308s027lbl.pdf', 'application_number': 18037, 'submission_type': 'SUPPL ', 'submission_number': 70} |
11,133 |
Emcyt®
estramustine phosphate sodium
capsules
DESCRIPTION
Estramustine phosphate sodium, an antineoplastic agent, is an off-white powder readily
soluble in water. EMCYT Capsules are white and opaque, each containing estramustine
phosphate sodium as the disodium salt monohydrate equivale... | custom-source | 2025-02-12T13:44:31.307243 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018045s023lbl.pdf', 'application_number': 18045, 'submission_type': 'SUPPL ', 'submission_number': 23} |
11,134 |
Bupivacaine Hydrochloride
Injection, USP
Bupivacaine Hydrochloride
and Epinephrine
Injection, USP
Rx only
DESCRIPTION
Bupivacaine
Hydrochloride
is
2-Piperidinecarboxamide,
1-butyl-N-(2,6-dime... | custom-source | 2025-02-12T13:44:31.579520 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018053s055lbl.pdf', 'application_number': 18053, 'submission_type': 'SUPPL ', 'submission_number': 55} |
11,135 |
Rx only
PLATINOL®
(cisplatin for injection, USP)
WARNING
PLATINOL (cisplatin for injection, USP) should be administered under the supervision
of a qualified physician experienced in the use of cancer chemotherapeutic agents.
Appropriate management of therapy and complications is possible only when adeq... | custom-source | 2025-02-12T13:44:31.679334 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018057s079lbl.pdf', 'application_number': 18057, 'submission_type': 'SUPPL ', 'submission_number': 79} |
11,136 |
Rx only
PLATINOL®
(cisplatin for injection, USP)
WARNING
PLATINOL (cisplatin for injection, USP) should be administered under the supervision
of a qualified physician experienced in the use of cancer chemotherapeutic agents.
Appropriate management of therapy and complications is possible only when adequ... | custom-source | 2025-02-12T13:44:31.774903 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s080lbl.pdf', 'application_number': 18057, 'submission_type': 'SUPPL ', 'submission_number': 80} |
11,137 |
CISplatin Injection
Rx only
WARNING
Cisplatin Injection should be administered under the supervision of a qualified physician
experienced in the use of... | custom-source | 2025-02-12T13:44:31.840528 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018057s083lbl.pdf', 'application_number': 18057, 'submission_type': 'SUPPL ', 'submission_number': 83} |
11,138 | 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
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:44:32.020800 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018060Orig1s066lbl.pdf', 'application_number': 18060, 'submission_type': 'SUPPL ', 'submission_number': 66} |
11,140 | PV 1354-A UCP
Cinobac®
Cinoxacin, USP
DESCRIPTION
Cinobac® (Cinoxacin, USP) is a synthetic antibacterial agent for oral administration. Cinoxacin,
a quinolone, is 1-ethyl-1,4-dihydro-4-oxo-[1,3] dioxolo [4,5-g] cinnoline-3-carboxylic acid and
occurs as white or very light-yellow, needle-shaped crystals. Cinobac is avai... | custom-source | 2025-02-12T13:44:32.118963 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18067s29lbl.pdf', 'application_number': 18067, 'submission_type': 'SUPPL ', 'submission_number': 29} |
11,139 | CORGARD® TABLETS
Nadolol Tablets USP
Rx Only
DESCRIPTION
CORGARD (nadolol) is a synthetic nonselective beta-adrenergic receptor blocking agent
designated chemically as 1-(tert-butylamino)-3-[(5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1-
naphthyl)oxy]-2-propanol. Structural formula:
C17H27NO4 MW 309.40
Nadolol... | custom-source | 2025-02-12T13:44:32.352629 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018063s060lbl.pdf', 'application_number': 18063, 'submission_type': 'SUPPL ', 'submission_number': 60} |
11,142 |
NDA 018081/S-046/S-048/S-050/S-052
NDA 018082/S-031/S-033/S-035/S-037
Depakene (valproic acid) capsules and oral solution
FDA Approved Labeling Text dated October 7, 2011
Page 3 of 48
FULL PRESCRIBING INFORMATION
BOXED WARNING
WARNING: LIFE THREATENING ADVERSE REACTIONS
Hepatotoxicity
Hep... | custom-source | 2025-02-12T13:44:32.619272 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf', 'application_number': 18081, 'submission_type': 'SUPPL ', 'submission_number': 50} |
11,143 |
NDA 018081/S-046/S-048/S-050/S-052
NDA 018082/S-031/S-033/S-035/S-037
Depakene (valproic acid) capsules and oral solution
FDA Approved Labeling Text dated October 7, 2011
Page 3 of 48
FULL PRESCRIBING INFORMATION
BOXED WARNING
WARNING: LIFE THREATENING ADVERSE REACTIONS
Hepatotoxicity
Hep... | custom-source | 2025-02-12T13:44:32.706254 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf', 'application_number': 18081, 'submission_type': 'SUPPL ', 'submission_number': 52} |
11,141 |
... | custom-source | 2025-02-12T13:44:32.788057 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s049,018082s034lbl.pdf', 'application_number': 18081, 'submission_type': 'SUPPL ', 'submission_number': 49} |
11,144 |
... | custom-source | 2025-02-12T13:44:33.020885 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s056lbl.pdf', 'application_number': 18081, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,146 |
HIGHLIGHTS OF PRESC... | custom-source | 2025-02-12T13:44:33.255378 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s059,018082s042lbl.pdf', 'application_number': 18081, 'submission_type': 'SUPPL ', 'submission_number': 59} |
11,145 |
HIGHLI... | custom-source | 2025-02-12T13:44:33.477197 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s058,018082s041lbl.pdf', 'application_number': 18081, 'submission_type': 'SUPPL ', 'submission_number': 58} |
11,148 |
NDA 018081/S-046/S-048/S-050/S-052
NDA 018082/S-031/S-033/S-035/S-037
Depakene (valproic acid) capsules and oral solution
FDA Approved Labeling Text dated October 7, 2011
Page 3 of 48
FULL PRESCRIBING INFORMATION
BOXED WARNING
WARNING: LIFE THREATENING ADVERSE REACTIONS
Hepatotoxicity
Hep... | custom-source | 2025-02-12T13:44:33.568815 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf', 'application_number': 18082, 'submission_type': 'SUPPL ', 'submission_number': 31} |
11,149 |
NDA 018081/S-046/S-048/S-050/S-052
NDA 018082/S-031/S-033/S-035/S-037
Depakene (valproic acid) capsules and oral solution
FDA Approved Labeling Text dated October 7, 2011
Page 3 of 48
FULL PRESCRIBING INFORMATION
BOXED WARNING
WARNING: LIFE THREATENING ADVERSE REACTIONS
Hepatotoxicity
Hep... | custom-source | 2025-02-12T13:44:33.758983 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf', 'application_number': 18082, 'submission_type': 'SUPPL ', 'submission_number': 33} |
11,150 |
... | custom-source | 2025-02-12T13:44:34.371403 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081S056lbl.pdf', 'application_number': 18082, 'submission_type': 'SUPPL ', 'submission_number': 39} |
11,152 |
... | custom-source | 2025-02-12T13:44:34.802440 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s061,018082s044lbl.pdf', 'application_number': 18082, 'submission_type': 'SUPPL ', 'submission_number': 44} |
11,147 |
... | custom-source | 2025-02-12T13:44:34.971393 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf', 'application_number': 18081, 'submission_type': 'SUPPL ', 'submission_number': 60} |
11,153 |
... | custom-source | 2025-02-12T13:44:35.462418 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s062,018082s045lbl.pdf', 'application_number': 18082, 'submission_type': 'SUPPL ', 'submission_number': 45} |
11,155 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
DEPAKENE safely and effectively. See full prescribing information for
DEPAKENE.
DEPAKENE (valproic acid), capsules, USP, for oral use
DEPAKENE (valproic acid) oral solution, USP
Initial U.S. Approval... | custom-source | 2025-02-12T13:44:35.949319 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018081s064,018082s047lbl.pdf', 'application_number': 18082, 'submission_type': 'SUPPL ', 'submission_number': 47} |
11,156 |
1
TOLECTIN® DS
(tolmetin sodium)
Capsules
TOLECTIN® 600
(tolmetin sodium)
Tablets
For Oral Administration
Cardiovascular Risk
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic
events, myocardial infarction, and stroke, which can be fatal. This risk may
increase with duration of ... | custom-source | 2025-02-12T13:44:35.977821 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017628s067,018084s051lbl.pdf', 'application_number': 18084, 'submission_type': 'SUPPL ', 'submission_number': 51} |
11,154 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
DEPAKENE safely and effectively. See full prescribing information for
DEPAKENE.
DEPAKENE (valproic acid), capsules, USP, for oral use
DEPAKENE (valproic acid) oral solution, USP
Initial U.S. Approval: 1978
... | custom-source | 2025-02-12T13:44:36.391021 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s063,018082s046lbl.pdf', 'application_number': 18082, 'submission_type': 'SUPPL ', 'submission_number': 46} |
11,151 |
... | custom-source | 2025-02-12T13:44:36.474036 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf', 'application_number': 18082, 'submission_type': 'SUPPL ', 'submission_number': 43} |
11,157 |
1
TOLECTIN DS
(tolmetin sodium)
Capsules
TOLECTIN 600
(tolmetin sodium)
Tablets
For Oral Administration
Cardiovascular Risk
•
NSAIDs may cause an increased risk of serious cardiovascular thrombotic
events, myocardial infarction, and stroke, which can be fatal. This risk may
increase with duration of... | custom-source | 2025-02-12T13:44:36.527933 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018084s052,017628s068lbl.pdf', 'application_number': 18084, 'submission_type': 'SUPPL ', 'submission_number': 52} |
11,158 | 9010842
1
STERILE OPHTHALMIC SOLUTION
TIMOPTIC®
0.25% AND 0.5%
(TIMOLOL MALEATE
OPHTHALMIC SOLUTION)
DESCRIPTION
TIMOPTIC* (timolol maleate ophthalmic solution) is a non-selective beta-adrenergic receptor blocking
agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol... | custom-source | 2025-02-12T13:44:36.582943 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18086S54lbl.pdf', 'application_number': 18086, 'submission_type': 'SUPPL ', 'submission_number': 54} |
11,162 | 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 | 2025-02-12T13:44:36.768332 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016023s039,018101s014lbl.pdf', 'application_number': 18101, 'submission_type': 'SUPPL ', 'submission_number': 14} |
11,159 | NDA 18-086/S-060
Page 3
STERILE OPHTHALMIC SOLUTION
TIMOPTIC®
0.25% AND 0.5%
(TIMOLOL MALEATE
OPHTHALMIC SOLUTION)
DESCRIPTION
TIMOPTIC (timolol maleate ophthalmic solution) is a non-selective beta-adrenergic receptor blocking
agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadia... | custom-source | 2025-02-12T13:44:36.823631 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18086scs060_timoptic_lbl.pdf', 'application_number': 18086, 'submission_type': 'SUPPL ', 'submission_number': 60} |
11,161 | Endo logo (scripted)
ENDO LABORATORIES
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.
• HCl
NH2
Amantadine hydrochloride ... | custom-source | 2025-02-12T13:44:36.882917 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf', 'application_number': 18101, 'submission_type': 'SUPPL ', 'submission_number': 9} |
11,160 | NDA 18-086/S-070
NDA 18-086/S-072
Page 3
STERILE OPHTHALMIC SOLUTION
TIMOPTIC®
0.25% AND 0.5%
(TIMOLOL MALEATE
OPHTHALMIC SOLUTION)
DESCRIPTION
TIMOPTIC* (timolol maleate ophthalmic solution) is a non-selective beta-adrenergic receptor blocking agent.
Its chemical name is (-)-1-(tert-butylamino)-3-[(4... | custom-source | 2025-02-12T13:44:36.920739 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018086s070s072lbl.pdf', 'application_number': 18086, 'submission_type': 'SUPPL ', 'submission_number': 70} |
11,163 |
logo
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.
• HCl
Chemical Structure
Amantadine hydroch... | custom-source | 2025-02-12T13:44:37.072088 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016023s040,018101s015lbl.pdf', 'application_number': 18101, 'submission_type': 'SUPPL ', 'submission_number': 15} |
11,166 | Azmacort
Azmacort
Azmacort
Azmacort®®®®
(triamcinolone acetonide)
(triamcinolone acetonide)
(triamcinolone acetonide)
(triamcinolone acetonide)
Inhalation Aerosol
Inhalation Aerosol
Inhalation Aerosol
Inhalation Aerosol
Rx Only
Rx Only
Rx Only
Rx Only
For Oral Inhalation Only
For Oral Inhalati... | custom-source | 2025-02-12T13:44:37.303193 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018117s042lbl.pdf', 'application_number': 18117, 'submission_type': 'SUPPL ', 'submission_number': 42} |
11,165 | Page 1
Rev. May 2003
Rx only
Azmacort®
(triamcinolone acetonide)
Inhalation Aerosol
For Oral Inhalation Only
Shake Well Before Using
DESCRIPTION
Triamcinolone acetonide, USP, the active ingredient in Azmacort® Inhalation Aerosol, is a
corticosteroid with a molecular weight of 434.5 and... | custom-source | 2025-02-12T13:44:37.382764 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr033_azmacort_lbl.pdf', 'application_number': 18117, 'submission_type': 'SUPPL ', 'submission_number': 33} |
11,164 | Page 1
Rev. September 2002
Rx only
Azmacort®
(triamcinolone acetonide)
Inhalation Aerosol
For Oral Inhalation Only
Shake Well Before Using
DESCRIPTION
Triamcinolone acetonide, USP, the active ingredient in Azmacort® Inhalation Aerosol, is a
corticosteroid with a molecular weight of 434... | custom-source | 2025-02-12T13:44:37.437909 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr032_azmacort_lbl.pdf', 'application_number': 18117, 'submission_type': 'SUPPL ', 'submission_number': 32} |
11,167 |
1
ATIVAN (lorazepam) Injection
Rx only
DESCRIPTION
Lorazepam, a benzodiazepine with antianxiety, sedative, and anticonvulsant effects, is
intended for the intramuscular or intravenous routes of administration. It has the
chemical formula: 7-chloro-5(2-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,
4-benzodiazep... | custom-source | 2025-02-12T13:44:37.449484 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018140s028lbl.pdf', 'application_number': 18140, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,170 |
FELDENE®
(piroxicam)
CAPSULES
10 mg and 20 mg
For Oral Use
Cardiovascular Risk
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with
cardiovascular... | custom-source | 2025-02-12T13:44:37.730717 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf', 'application_number': 18147, 'submission_type': 'SUPPL ', 'submission_number': 33} |
11,171 |
FELDENE®
(piroxicam)
CAPSULES
10 mg and 20 mg
For Oral Use
Cardiovascular Risk
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with
cardiovascular... | custom-source | 2025-02-12T13:44:37.812939 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf', 'application_number': 18147, 'submission_type': 'SUPPL ', 'submission_number': 39} |
11,169 |
s
t
ruc
tur
al
for
mul
a
FELDENE®
(piroxicam)
CAPSULES
10 mg and 20 mg
For Oral Use
Cardiovascular Risk
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase with d... | custom-source | 2025-02-12T13:44:37.913560 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018147s032lbl.pdf', 'application_number': 18147, 'submission_type': 'SUPPL ', 'submission_number': 32} |
11,168 | NDA 18-147/S-029
Page 3
FELDENE®
(piroxicam)
CAPSULES
10 mg and 20 mg
For Oral Use
Cardiovascular Risk
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patient’s
with ... | custom-source | 2025-02-12T13:44:37.919583 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018147s029lbl.pdf', 'application_number': 18147, 'submission_type': 'SUPPL ', 'submission_number': 29} |
11,172 |
FELDENE®
(piroxicam)
CAPSULES
10 mg and 20 mg
For Oral Use
Cardiovascular Risk
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with
cardiovascular... | custom-source | 2025-02-12T13:44:38.076210 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf', 'application_number': 18147, 'submission_type': 'SUPPL ', 'submission_number': 42} |
11,173 |
Loniten®
minoxidil tablets, USP
WARNINGS
LONITEN Tablets contain the powerful antihypertensive agent, minoxidil, which may
produce serious adverse effects. It can cause pericardial effusion, occasionally
progressing to tamponade, and a... | custom-source | 2025-02-12T13:44:38.167778 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf', 'application_number': 18154, 'submission_type': 'SUPPL ', 'submission_number': 26} |
11,174 |
NDA 18163 FDA Approved Labeling text 11.4.10
Restoril™
(temazepam)
Capsules USP company logo
Rx only
DESCRIPTION
Restoril™ (temazepam) is a benzodiazepine hypnotic agent. The chemical name is 7-chloro
1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodi... | custom-source | 2025-02-12T13:44:38.324763 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018163s054lbl.pdf', 'application_number': 18163, 'submission_type': 'SUPPL ', 'submission_number': 54} |
11,176 |
1
2
EC-NAPROSYN® (naproxen delayed-release tablets)
3
NAPROSYN® (naproxen tablets)
4
ANAPROX®/ANAPROX® DS (naproxen sodium tablets)
5
NAPROSYN® (naproxen suspension) Roche Logo
6
Rx only
Cardiovascular Risk
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic
even... | custom-source | 2025-02-12T13:44:38.440872 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf', 'application_number': 18164, 'submission_type': 'SUPPL ', 'submission_number': 60} |
11,175 | 18163/S-058 S-059 FDA Approved Labeling Text 2.25.08
Page 1 of 15
Restoril™
(temazepam)
Capsules USP
Rx only
DESCRIPTION
Restoril™ (temazepam) is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-
1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural ... | custom-source | 2025-02-12T13:44:38.488312 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018163s058s059lbl.pdf', 'application_number': 18163, 'submission_type': 'SUPPL ', 'submission_number': 59} |
11,177 | EC-NAPROSYN (naproxen delayed-release tablets)
NAPROSYN (naproxen tablets)
ANAPROX/ANAPROX DS (naproxen sodium tablets)
NAPROSYN (naproxen suspension)
Rx only
Cardiovascular Risk
NSAIDs may cause an increased risk of serious cardiovascular thrombotic
events, myocardial infarction, and stroke, which can b... | custom-source | 2025-02-12T13:44:38.715495 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf', 'application_number': 18164, 'submission_type': 'SUPPL ', 'submission_number': 61} |
11,178 |
EC-NAPROSYN (naproxen delayed-release tablets)
NAPROSYN (naproxen tablets)
ANAPROX/ANAPROX DS (naproxen sodium tablets)
Rx only
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND
GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) ca... | custom-source | 2025-02-12T13:44:38.835326 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,020067s019lbl.pdf', 'application_number': 18164, 'submission_type': 'SUPPL ', 'submission_number': 62} |
11,179 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do n... | custom-source | 2025-02-12T13:44:39.032503 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf', 'application_number': 18185, 'submission_type': 'SUPPL ', 'submission_number': 55} |
11,180 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do n... | custom-source | 2025-02-12T13:44:39.055073 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf', 'application_number': 18185, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,181 | custom-source | 2025-02-12T13:44:39.158021 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-200S024_Midamor_Prntlbl.pdf', 'application_number': 18201, 'submission_type': 'SUPPL ', 'submission_number': 37} | |
11,183 | NDA 17-577 DITROPAN (oxybutynin chloride) Tablets (Final Draft submitted 4/9/2003)
NDA 18-211 DITROPAN (oxybutynin chloride) Syrup (Final Draft submitted 4/9/2003)
1
DITROPAN®
(oxybutynin chloride)
Tablets and Syrup
DESCRIPTION
Each scored biconvex, engraved blue DITROPAN (oxybutynin chloride) Tablet contains
5 mg o... | custom-source | 2025-02-12T13:44:39.377705 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf', 'application_number': 18211, 'submission_type': 'SUPPL ', 'submission_number': 14} |
11,184 | custom-source | 2025-02-12T13:44:39.391672 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf', 'application_number': 18225, 'submission_type': 'SUPPL ', 'submission_number': 19} | |
11,182 | NDA 18-202/S-021
Page 3
Cytadren® Tablets
aminoglutethimide tablets USP
Rx only
Prescribing Information
DESCRIPTION
Cytadren, aminoglutethimide tablets USP, is an inhibitor of adrenocortical steroid synthesis, available
as 250-mg tablets for oral administration. Its chemical name is 3-(4-aminophenyl)... | custom-source | 2025-02-12T13:44:39.420485 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018202s021lbl.pdf', 'application_number': 18202, 'submission_type': 'SUPPL ', 'submission_number': 21} |
11,185 |
NDA 18225/S-024
Page 3
BUMEX
Brand of
bumetanide
TABLETS
WARNING
Bumex (bumetanide) is a potent diuretic which, if given in excessive amounts, can lead to a
profound diuresis with water and electrolyte depletion. Therefore, careful medical supervisi... | custom-source | 2025-02-12T13:44:39.455022 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018225s024lbl.pdf', 'application_number': 18225, 'submission_type': 'SUPPL ', 'submission_number': 24} |
11,186 |
1
HALOG-E CREAM
(Halcinonide Cream, USP) 0.1%
For Topical Use Only.
Not For Ophthalmic Use.
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-
inflammatory and antipruritic agents. The steroids in this class include halcinonide.
Halcinonide is designate... | custom-source | 2025-02-12T13:44:39.885606 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18234s020lbl.pdf', 'application_number': 18234, 'submission_type': 'SUPPL ', 'submission_number': 20} |
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