id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
11,289 |
_______________________________________________________________________________________________________________________________________
HIGHLIGHTS OF PR... | custom-source | 2025-02-12T13:44:52.722897 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018708s020s021lbl.pdf', 'application_number': 18708, 'submission_type': 'SUPPL ', 'submission_number': 20} |
11,288 |
... | custom-source | 2025-02-12T13:44:52.754491 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018705s017lbl.pdf', 'application_number': 18705, 'submission_type': 'SUPPL ', 'submission_number': 17} |
11,290 |
_______________________________________________________________________________________________________________________________________
HIGHLIGHTS OF PR... | custom-source | 2025-02-12T13:44:52.838750 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018708s020s021lbl.pdf', 'application_number': 18708, 'submission_type': 'SUPPL ', 'submission_number': 21} |
11,291 |
MYCELEX®
(clotrimazole) TROCHE
FOR TOPICAL ORAL ADMINISTRATION
DESCRIPTION Each Mycelex® Troche contains 10 mg clotrimazole [1-(o-chloro-α,α-diphenylbenzyl) imidazole], a synthetic antifungal agent, for
topical use in the mouth.
Structural Formula:
Chemical Formula:
C22H17CIN2
The tr... | custom-source | 2025-02-12T13:44:53.154612 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18713slr019_mycelex_lbl.pdf', 'application_number': 18713, 'submission_type': 'SUPPL ', 'submission_number': 19} |
11,292 | N
O
N
c
O
BILTRICIDE®
TABLETS
(praziquantel)
DESCRIPTION
BILTRICIDE® (praziquantel) is a trematodicide provided in tablet form for the oral treatment of
schistosome infections and infections due to liver fluke.
BILTRICIDE® (praziquantel) is 2-(cyclohexylcarbonyl)-1,2,3,6,7, 11b-hexahydro-4H-pyrazino
[2, 1-a] isoquinoli... | custom-source | 2025-02-12T13:44:53.235370 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf', 'application_number': 18714, 'submission_type': 'SUPPL ', 'submission_number': 8} |
11,293 |
BILTRICIDE®
TABLETS
(praziquantel)
DESCRIPTION
BILTRICIDE® (praziquantel) is a trematodicide provided in tablet form for the oral treatment
of schistosome infections and infections due to liver fluke.
BILTRICIDE (praziquantel) is 2-(cyclohexylcarbonyl)-1,2,3,6,7, 11b-hexahydro-4H-pyr... | custom-source | 2025-02-12T13:44:53.262143 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018714s012lbl.pdf', 'application_number': 18714, 'submission_type': 'SUPPL ', 'submission_number': 12} |
11,294 |
BILTRICIDE®
TABLETS
(praziquantel)
MM/14
DESCRIPTION
BILTRICIDE® (praziquantel) is a trematodicide provided in tablet form for the oral treatment
of schistosome infections and infections due to liver fluke.
BILTRICIDE (praziquantel) is 2-(cyclohexylcarbonyl)-1,2,3,6,7, 11b-hexah... | custom-source | 2025-02-12T13:44:53.318736 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018714s013lbl.pdf', 'application_number': 18714, 'submission_type': 'SUPPL ', 'submission_number': 13} |
11,295 | NDA 018723/S-037/S-040/S-043/S-045/S-046
Depakote (divalproex sodium) Tablets for Oral use
FDA Approved Labeling Text dated October 7, 2011
Page 1 of 57
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Depakote safely and effectively. See full prescribing i... | custom-source | 2025-02-12T13:44:53.522047 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf', 'application_number': 18723, 'submission_type': 'SUPPL ', 'submission_number': 37} |
11,296 | NDA 018723/S-037/S-040/S-043/S-045/S-046
Depakote (divalproex sodium) Tablets for Oral use
FDA Approved Labeling Text dated October 7, 2011
Page 1 of 57
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Depakote safely and effectively. See full prescribing i... | custom-source | 2025-02-12T13:44:53.680741 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf', 'application_number': 18723, 'submission_type': 'SUPPL ', 'submission_number': 40} |
11,299 | NDA 018723/S-037/S-040/S-043/S-045/S-046
Depakote (divalproex sodium) Tablets for Oral use
FDA Approved Labeling Text dated October 7, 2011
Page 1 of 57
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Depakote safely and effectively. See full prescribing i... | custom-source | 2025-02-12T13:44:54.023471 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf', 'application_number': 18723, 'submission_type': 'SUPPL ', 'submission_number': 45} |
11,297 |
... | custom-source | 2025-02-12T13:44:54.158922 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018723s041lbl.pdf', 'application_number': 18723, 'submission_type': 'SUPPL ', 'submission_number': 41} |
11,300 | NDA 018723/S-037/S-040/S-043/S-045/S-046
Depakote (divalproex sodium) Tablets for Oral use
FDA Approved Labeling Text dated October 7, 2011
Page 1 of 57
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Depakote safely and effectively. See full prescribing i... | custom-source | 2025-02-12T13:44:54.509461 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf', 'application_number': 18723, 'submission_type': 'SUPPL ', 'submission_number': 46} |
11,301 |
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
... | custom-source | 2025-02-12T13:44:54.539960 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018723s047lbl.pdf', 'application_number': 18723, 'submission_type': 'SUPPL ', 'submission_number': 47} |
11,302 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Depakote safely and effectively. See full prescribing information for
Depakote.
Depakote (divalproex sodium) Tablets for Oral use
Initial U.S. Approval: 1983
WARNINGS: LIFE THREATENING ADVERSE REACTIONS
See fu... | custom-source | 2025-02-12T13:44:54.904446 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018723s048lbl.pdf', 'application_number': 18723, 'submission_type': 'SUPPL ', 'submission_number': 48} |
11,303 |
... | custom-source | 2025-02-12T13:44:55.245528 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018723s050lbl.pdf', 'application_number': 18723, 'submission_type': 'SUPPL ', 'submission_number': 50} |
11,304 |
... | custom-source | 2025-02-12T13:44:55.283534 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018723s051lbl.pdf', 'application_number': 18723, 'submission_type': 'SUPPL ', 'submission_number': 51} |
11,305 |
... | custom-source | 2025-02-12T13:44:55.457396 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018723s053lbl.pdf', 'application_number': 18723, 'submission_type': 'SUPPL ', 'submission_number': 53} |
11,306 | dn3344v4-proposed-depakote-tab-obesity-nail-ddis-2016-feb-17 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Depakote safely and effectively. See full prescribing information for
Depakote.
Depakote (divalproex sodium) tablets, for oral use
Initial U.S... | custom-source | 2025-02-12T13:44:55.684532 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018723s056lbl.pdf', 'application_number': 18723, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,307 | 1
Bristol-Myers Squibb Company
BuSpar®
(buspirone HCl, USP)
(Patient Instruction Sheet Included)
DESCRIPTION
BuSpar® (buspirone hydrochloride, USP) is an antianxiety agent that is not chemically or
pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs.
Buspirone hydrochlorid... | custom-source | 2025-02-12T13:44:55.739972 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s39s45lbl.pdf', 'application_number': 18731, 'submission_type': 'SUPPL ', 'submission_number': 39} |
11,308 | NDA 18-731/S-043
Page 3
Bristol-Myers Squibb Company
BuSpar®
(buspirone HCl, USP)
(Patient Instruction Sheet Included)
DESCRIPTION
BuSpar® (buspirone hydrochloride, USP) is an antianxiety agent that is not chemically or
pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs.
... | custom-source | 2025-02-12T13:44:55.856175 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s43lbl.pdf', 'application_number': 18731, 'submission_type': 'SUPPL ', 'submission_number': 43} |
11,309 |
company logo
Rx only
BuSpar®
(buspirone HCl, USP)
(Patient Instruction Sheet Included)
DESCRIPTION
BuSpar® (buspirone hydrochloride tablets, USP) is an antianxiety agent that is not
chemically or pharmacologically related to the benzodiazepines, barbiturates, or other
sedat... | custom-source | 2025-02-12T13:44:55.888663 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf', 'application_number': 18731, 'submission_type': 'SUPPL ', 'submission_number': 51} |
11,310 |
TALWIN® Nx CIV
pentazocine and naloxone
hydrochlorides, USP
Analgesic for Oral Use
Only
TALWIN® Nx is intended for oral use only. Severe, potentially lethal, reactions may
result from misuse of TALWIN® Nx by injection either alone or in combination with ... | custom-source | 2025-02-12T13:44:56.065503 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018733s014lbl.pdf', 'application_number': 18733, 'submission_type': 'SUPPL ', 'submission_number': 14} |
11,311 |
Rx only
Exelderm
(sulconazole nitrate)
Cream, 1.0%
For topical use only. Not for ophthalmic use.
DESCRIPTION
EXELDERM (sulconazole nitrate) CREAM, 1.0% is a broad-spectrum antifungal agent intended for
topical application. Sulconazole nitrate, the active ingredient in EXELDERM CREAM, is an imidazole ... | custom-source | 2025-02-12T13:44:56.133416 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18737slr003_exelderm_lbl.pdf', 'application_number': 18737, 'submission_type': 'SUPPL ', 'submission_number': 3} |
11,313 |
Exelderm® (sulconazole nitrate)
Solution, 1.0%
For topical use only. Not for ophthalmic use.
DESCRIPTION
EXELDERM (sulconazole nitrate) SOLUTION, 1.0% is a broad-spectrum antifungal agent intended
for topical application. Sulconazole nit... | custom-source | 2025-02-12T13:44:56.155368 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018738s009lbl.pdf', 'application_number': 18738, 'submission_type': 'SUPPL ', 'submission_number': 9} |
11,312 |
Rx only
Exelderm
(sulconazole nitrate)
Cream, 1.0%
For topical use only. Not for ophthalmic use.
DESCRIPTION
EXELDERM (sulconazole nitrate) CREAM, 1.0% is a broad-spectrum antifungal agent intended for
topical application. Sulconazole nitrate, the active ingredient in EXELDERM CREAM, is an imidazole ... | custom-source | 2025-02-12T13:44:56.188793 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18737slr003_exelderm_lbl.pdf', 'application_number': 18738, 'submission_type': 'SUPPL ', 'submission_number': 7} |
11,314 |
3
DIPROLENE®
1
brand of augmented betamethasone dipropionate ointment*
2
Ointment 0.05% (potency expressed as betamethasone)
3
*Vehicle augments the penetration of the steroid.
4
For Dermatologic Use Only -
5
Not for Ophthalmic Use
6
DESCRIPTION DIPROLENE® (augmented betame... | custom-source | 2025-02-12T13:44:56.397863 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s016lbl.pdf', 'application_number': 18741, 'submission_type': 'SUPPL ', 'submission_number': 16} |
11,316 |
... | custom-source | 2025-02-12T13:44:56.452833 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018751s023lbledt.pdf', 'application_number': 18751, 'submission_type': 'SUPPL ', 'submission_number': 23} |
11,315 | 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 | 2025-02-12T13:44:56.549729 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18748slr010_loprox_lbl.pdf', 'application_number': 18748, 'submission_type': 'SUPPL ', 'submission_number': 10} |
11,317 |
TENORETIC®
(atenolol and chlorthalidone)
DESCRIPTION
TENORETIC® (atenolol and chlorthalidone) is for the
treatment of hypertension. It combines the antihypertensive
activity of two agents: a beta1-selective (cardioselective)
hydrophilic blocking agent (atenolol, TENORMI... | custom-source | 2025-02-12T13:44:56.662107 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018760s028lbl.pdf', 'application_number': 18760, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,319 | Topicort Ointme
®
nt
(desoximetasone) 0.25%
IC USE ONLY.
OR USE IN EYES.
Topicort (desoximetasone) Ointment 0.25% contains the active synthetic corticosteroid
imarily synthetic
t contains 2.5 mg of Desoximetasone in a base
esquioleate,
, Fatty Acid Pentaerythritol Ester, Aluminum Stearate,
Citric Acid, and... | custom-source | 2025-02-12T13:44:56.716276 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18763slr003_topicort_lbl.pdf', 'application_number': 18763, 'submission_type': 'SUPPL ', 'submission_number': 3} |
11,318 |
s
t
ructural formula
s
tructural formula
TENORETIC®
(atenolol and chlorthalidone)
DESCRIPTION
TENORETIC® (atenolol and chlorthalidone) is for the treatment of hypertension. It combines
the antihypertensive activity of two agents: a beta1-selective (cardioselective) hydrophil... | custom-source | 2025-02-12T13:44:56.824577 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018760s029lbl.pdf', 'application_number': 18760, 'submission_type': 'SUPPL ', 'submission_number': 29} |
11,320 | NDA 18-766/S-013
Page 3
Ansaid
flurbiprofen tablets, USP
Ansaid
(flurbiprofen tablets, USP) 50mg and 10 mg
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 o... | custom-source | 2025-02-12T13:44:57.030735 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018766s013lbl.pdf', 'application_number': 18766, 'submission_type': 'SUPPL ', 'submission_number': 13} |
11,322 | Rx only
VePesid
®
(etoposide)
For Injection and Capsules
DESCRIPTION
VePesid® (etoposide) (also commonly known as VP-16) is a semisynthetic derivative of
podophyllotoxin used in the treatment of certain neoplastic diseases. It is
4'-demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside]. It is very
sol... | custom-source | 2025-02-12T13:44:57.231754 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/019557s028lbl.pdf', 'application_number': 18768, 'submission_type': 'SUPPL ', 'submission_number': 45} |
11,321 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
Th... | custom-source | 2025-02-12T13:44:57.303366 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018766s020lbl.pdf', 'application_number': 18766, 'submission_type': 'SUPPL ', 'submission_number': 20} |
11,326 |
1
PA 3052 AMP
1
INFORMATION FOR THE PHYSICIAN
2
HUMULIN® R
3
REGULAR
4
U-500 (CONCENTRATED)
5
INSULIN HUMAN INJECTION, USP
6
(rDNA ORIGIN)
7
DESCRIPTION
8
Humulin is synthesized in a special non-disease-producing laboratory strain of Escherichia
9
coli bacteria that has been genetically altered by ... | custom-source | 2025-02-12T13:44:57.520702 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s114lbl.pdf', 'application_number': 18780, 'submission_type': 'SUPPL ', 'submission_number': 114} |
11,325 |
1
A1.0 NL 5691 AMP
A1.0 NL 5681 AMP
A2.0 NL 4460 AMP
INFORMATION FOR THE PATIENT
10 mL Vial (1000 Units per vial)
HUMULIN® R
REGULAR
INSULIN HUMAN INJECTION, USP
(rDNA ORIGIN)
100 UNITS PER ML (U-100)
WARNINGS
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM
ANIMAL-SOURCE INSULINS BECAUSE IT IS STRUCTURAL... | custom-source | 2025-02-12T13:44:57.562017 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf', 'application_number': 18780, 'submission_type': 'SUPPL ', 'submission_number': 95} |
11,335 |
1
Submission date: 8/4/04
2.0 PV 3682 AMP
1
INFORMATION FOR THE PATIENT
2
3 ML DISPOSABLE INSULIN DELIVERY DEVICE
3
HUMULIN® N Pen
4
NPH
5
HUMAN INSULIN
6
(rDNA ORIGIN) ISOPHANE SUSPENSION
7
100 UNITS PER ML (U-100)
8
WARNINGS
9
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL-
10
SOURCE INS... | custom-source | 2025-02-12T13:44:57.812610 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18781s079lbl.pdf', 'application_number': 18781, 'submission_type': 'SUPPL ', 'submission_number': 79} |
11,342 |
Heparin Sodium in 5% Dextrose Injection
in Plastic Container
VIAFLEX Plus Container (PL 146 Plastic)
DESCRIPTION
Heparin Sodium in 5% Dextrose Injection is a buffered, sterile, nonpyrogenic solution of
Heparin Sodium, USP, derived from porcine intestinal mucosa, standardized for
anticoagulant activity, a... | custom-source | 2025-02-12T13:44:57.933866 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018814s032lbl.pdf', 'application_number': 18814, 'submission_type': 'SUPPL ', 'submission_number': 32} |
11,330 |
B1.0NL3055AMP
... | custom-source | 2025-02-12T13:44:58.004295 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018780s148lbl.pdf', 'application_number': 18780, 'submission_type': 'SUPPL ', 'submission_number': 148} |
11,338 |
5
10
15
20
25
30
35
40
45
1
1
PV 5713 AMP
2
... | custom-source | 2025-02-12T13:44:58.044099 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018781s120lbl.pdf', 'application_number': 18781, 'submission_type': 'SUPPL ', 'submission_number': 120} |
11,343 | Page 1
LOTRISONE® Cream, USP
1
LOTRISONE® Lotion
2
(clotrimazole, USP and betamethasone dipropionate, USP)
3
FOR TOPICAL USE ONLY, NOT
FOR
OPHTHALMIC,
ORAL,
OR
4
INTRAVAGINAL USE, NOT RECOMMENDED FOR PATIENTS UNDER THE
5
AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER DERMATITIS
6
DESCRIPTION LOTRISONE Cream and Lo... | custom-source | 2025-02-12T13:44:58.395884 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18827slr025_lotrisone_lbl.pdf', 'application_number': 18827, 'submission_type': 'SUPPL ', 'submission_number': 25} |
11,345 |
LOTRISONE® Cream
LOTRISONE® Lotion
(clotrimazole and betamethasone dipropionate)
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE. NOT RECOMMENDED FOR PATIENTS UNDER THE
AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER DERMATITIS.
DESCRIPTION
... | custom-source | 2025-02-12T13:44:58.423877 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018827s042lbl.pdf', 'application_number': 18827, 'submission_type': 'SUPPL ', 'submission_number': 42} |
11,346 |
... | custom-source | 2025-02-12T13:44:58.519379 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018827s046lbl.pdf', 'application_number': 18827, 'submission_type': 'SUPPL ', 'submission_number': 46} |
11,344 |
LOTRISONE® Cream
LOTRISONE® Lotion
(clotrimazole and betamethasone dipropionate)
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE. NOT RECOMMENDED FOR PATIENTS UNDER THE
AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER DERMATITIS.
DESCRIPTION
LOTRISONE® Cream and Lotion co... | custom-source | 2025-02-12T13:44:58.585849 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018827s038lbl.pdf', 'application_number': 18827, 'submission_type': 'SUPPL ', 'submission_number': 38} |
11,349 | Description
5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes
and Dextrose Injection, Type 3, USP) is a sterile, nonpyrogenic
solution for fluid and electrolyte replenishment and caloric supply
in a single dose container for intravenous administration. Each
100 mL contains 5 g Dextrose Hydrous, USP*,... | custom-source | 2025-02-12T13:44:58.789722 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018840s028lbl.pdf', 'application_number': 18840, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,348 | 1
PRESCRIBING INFORMATION
ZOVIRAX®
(acyclovir)
Capsules
ZOVIRAX®
(acyclovir)
Tablets
ZOVIRAX®
(acyclovir)
Suspension
DESCRIPTION
ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against
herpesviruses. ZOVIRAX Capsules, Tablets, and Suspension are formulations for ... | custom-source | 2025-02-12T13:44:59.024942 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018828s031lbl.pdf', 'application_number': 18828, 'submission_type': 'SUPPL ', 'submission_number': 31} |
11,347 | NDA 18-828/SLR-029
NDA 19-909/SLR-019
NDA 20-089/SLR-018
Page 3
PRESCRIBING INFORMATION
ZOVIRAX®
(acyclovir)
Capsules
ZOVIRAX®
(acyclovir)
Tablets
ZOVIRAX®
(acyclovir)
Suspension
DESCRIPTION
ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against ... | custom-source | 2025-02-12T13:44:59.034578 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18828slr029,19909slr019,20089slr018_zovirax_lbl.pdf', 'application_number': 18828, 'submission_type': 'SUPPL ', 'submission_number': 29} |
11,350 | January 25, 2002
1
SEARLE
Daypro®
(oxaprozin) Caplets
600 mg
DESCRIPTION
Daypro (oxaprozin) is a nonsteroidal anti-inflammatory drug (NSAID), chemically designated as 4,5-diphenyl-2-
oxazole-propionic acid, and has the following chemical structure:
The empirical formula for oxaprozin is C18H15NO3, and the molecular wei... | custom-source | 2025-02-12T13:44:59.094015 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18841s12s16lbl.pdf', 'application_number': 18841, 'submission_type': 'SUPPL ', 'submission_number': 16} |
11,351 | DAYPRO®
(oxaprozin) 600mg Caplets
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 factors for cardiovascular dis... | custom-source | 2025-02-12T13:44:59.306765 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/18841s022lbl.pdf', 'application_number': 18841, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,354 |
CALCIJEX®
(calcitriol injection)
1 mcg/mL
DESCRIPTION
Calcijex (calcitriol injection) is synthetically manufactured calcitriol and is available as a sterile, isotonic,
clear, colorless to yellow, aqueous solution for intravenous injection. Calcijex is available in 1 mL ampuls.
Each 1 mL contains calcitriol, ... | custom-source | 2025-02-12T13:44:59.432118 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018874s022lbl.pdf', 'application_number': 18874, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,353 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information... | custom-source | 2025-02-12T13:44:59.648588 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf', 'application_number': 18858, 'submission_type': 'SUPPL ', 'submission_number': 41} |
11,355 | STERILE
INDOCIN~I.V.
(Indomethacin for Injection)
Rx only No. 511
DESCRIPTION
Sterile INDOCIN* LV. (Indomethacin for Injection) for intravenous administration is lyophilized
indomethacin for injection. Each vial contains indomethacin for injection equivalent to 1 mg
indomethacin as a white to yellow lyophilized powder ... | custom-source | 2025-02-12T13:44:59.827129 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018878s024lbl.pdf', 'application_number': 18878, 'submission_type': 'SUPPL ', 'submission_number': 24} |
11,356 | Figure 1: DELFLEX® Conventional with stay•safe® Exchange Set– 2.5% Dextrose,
Low Mg/Low Ca
Figure 2: DELFLEX® Conventional with stay•safe® Exchange Set – 4.25% Dextrose,
Low Mg/Standard Ca
Reference ID: 3683488
This label may not be the latest approved by FDA.
For current labeling information, please ... | custom-source | 2025-02-12T13:44:59.924786 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018883Orig1s057,020171Orig1s039lbl.pdf', 'application_number': 18883, 'submission_type': 'SUPPL ', 'submission_number': 57} |
11,352 |
... | custom-source | 2025-02-12T13:45:00.009306 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018851s025lbl.pdf', 'application_number': 18851, 'submission_type': 'SUPPL ', 'submission_number': 25} |
11,357 |
Boehringer Ingelheim
Catapres-TTS
®
(clonidine)
Catapres-TTS® -1
Catapres-TTS® -2
Catapres-TTS® -3
Transdermal Therapeutic System
Programmed delivery in vivo of 0.1, 0.2, or 0.3 mg clonidine per day, for one week.
Rx only
Prescribing Informat... | custom-source | 2025-02-12T13:45:00.346464 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018891s025lbl.pdf', 'application_number': 18891, 'submission_type': 'SUPPL ', 'submission_number': 25} |
11,359 |
Intravenous Solutions
Rx only
with Heparin Sodium Injection
12,500 or 25,000 USP Units of Heparin Sodium in
0.45% Sodium Chloride Injection
Flexible Plastic Container
DESCRIPTION
Intravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are... | custom-source | 2025-02-12T13:45:00.426834 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018916s057lbl.pdf', 'application_number': 18916, 'submission_type': 'SUPPL ', 'submission_number': 57} |
11,360 | Reference ID: 2912664
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Reference ID: 2912664
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Reference ID: ... | custom-source | 2025-02-12T13:45:00.470218 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018917s025lbl.pdf', 'application_number': 18917, 'submission_type': 'SUPPL ', 'submission_number': 25} |
11,358 |
company logo
Catapres-TTS
®
(clonidine)
Catapres-TTS® -1
Catapres-TTS® -2
Catapres-TTS® -3
Transdermal Therapeutic System
Programmed delivery in vivo of 0.1, 0.2, or 0.3 mg clonidine per day, for one week.
Rx only
Prescribing Information
DES... | custom-source | 2025-02-12T13:45:00.540645 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018891s028lbl.pdf', 'application_number': 18891, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,361 |
07-19-75-231
Baxter
Lactated Ringer’s Irrigation
in ARTHROMATIC Plastic Container
DESCRIPTION
Lactated Ringer’s Irrigation is a sterile, nonpyrogenic, isotonic solution in a single dose
ARTHROMATIC plastic container f... | custom-source | 2025-02-12T13:45:00.699895 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018921s031lbl.pdf', 'application_number': 18921, 'submission_type': 'SUPPL ', 'submission_number': 31} |
11,363 |
CALAN®
(verapamil hydrochloride)
For Intravenous Injection
DESCRIPTION
CALAN (verapamil HCl) is a calcium antagonist or slow-channel inhibitor available as a sterile
solution for intravenous injection in 5-mg (2 ml) ampules, 5-mg (2 ml) and 10-mg (4 ml)
syringes, and 5-mg (2 ml... | custom-source | 2025-02-12T13:45:02.098293 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018925s008lbl.pdf', 'application_number': 18925, 'submission_type': 'SUPPL ', 'submission_number': 8} |
11,365 | Page 3
Tegretol®
carbamazepine USP
Chewable Tablets of 100 mg - red-speckled, pink
Tablets of 200 mg – pink
Suspension of 100 mg/5 mL
Tegretol®-XR
(carbamazepine extended-release tablets)
100 mg, 200 mg, 400 mg
Rx only
Prescribing Information
WARNING
APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN... | custom-source | 2025-02-12T13:45:02.233415 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf', 'application_number': 18927, 'submission_type': 'SUPPL ', 'submission_number': 35} |
11,362 | NDA 18-922/S-021
Page 3
Lodine
(etodolac capsules 200 and 300 mg, and etodolac tablets 400 and 500 mg)
] only
DescriptionDESCRIPTION
Lodine (etodolac capsules and tablets) is a member of the pyranocarboxylic acid group of
nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains et... | custom-source | 2025-02-12T13:45:02.321699 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018922s021lbl.pdf', 'application_number': 18922, 'submission_type': 'SUPPL ', 'submission_number': 21} |
11,366 |
company logo
Tegretol®
carbamazepine USP
Chewable Tablets of 100 mg - red-speckled, pink
Tablets of 200 mg – pink
Suspension of 100 mg/5 mL
Tegretol®-XR
(carbamazepine extended-release tablets)
100 mg, 200 mg, 400 mg
Rx only
Prescribing Information
WARNINGS
SERIOUS DERMATOLOGIC REACTIONS AND... | custom-source | 2025-02-12T13:45:02.537322 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf', 'application_number': 18927, 'submission_type': 'SUPPL ', 'submission_number': 41} |
11,367 |
company logo
Tegretol®
carbamazepine USP
Chewable Tablets of 100 mg - red-speckled, pink
Tablets of 200 mg – pink
Suspension of 100 mg/5 mL
Tegretol®-XR
(carbamazepine extended-release tablets)
100 mg, 200 mg, 400 mg
Rx only
Prescribing Information
WARNINGS
SERIOUS DERMATOLOGIC REACTIONS AND... | custom-source | 2025-02-12T13:45:02.788409 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf', 'application_number': 18927, 'submission_type': 'SUPPL ', 'submission_number': 42} |
11,368 |
N 016608/S-103
N 018281/S-051
N 020234/S-035
N 018927/S-044
FDA Approved labeling dated 01/16/2014
Page 1
Tegretol®
carbamazepine USP
Chewable Tablets of 100 mg - red-speckled, pink
Tablets of 200 mg – pink
Suspension of 100 mg/5 mL
Tegretol®-XR
(carbamazepine extended-release tablets)
... | custom-source | 2025-02-12T13:45:02.999115 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf', 'application_number': 18927, 'submission_type': 'SUPPL ', 'submission_number': 44} |
11,369 |
NDA 016608/S-107
NDA 018281/S-055
NDA 018927/S-048
NDA 020234/S-040
FDA Approved Labeling Text dated 12/11/2012
Page 1 company logo
Tegretol®
carbamazepine USP
Chewable Tablets of 100 mg - red-speckled, pink
Tablets of 200 mg – pink
Suspension of 100 mg/5 mL
Tegretol®-XR
(carbamazepine extended... | custom-source | 2025-02-12T13:45:03.007589 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf', 'application_number': 18927, 'submission_type': 'SUPPL ', 'submission_number': 48} |
11,371 | NDA 18-936/S-064
Approved Labeling Enclosure
Page 1
1
ENCLOSURE
[Note: Below is the Agency’s final labeling for Prozac to incorporate the new
pediatric major depressive disorder and obsessive compulsive disorder changes
to the Prozac labeling.]
PROZAC®
FLUOXETINE HYDROCHLORIDE
DESCRIPTION
Prozac® (fluoxetine hydrochlor... | custom-source | 2025-02-12T13:45:03.677607 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018936s064lbl.pdf', 'application_number': 18936, 'submission_type': 'SUPPL ', 'submission_number': 64} |
11,372 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to ... | custom-source | 2025-02-12T13:45:04.455588 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf', 'application_number': 18936, 'submission_type': 'SUPPL ', 'submission_number': 77} |
11,374 |
1
1
2
3
4
5
PV 5324 DPP
PROZAC®
FLUOXETINE CAPSULES, USP
FLUOXETINE ORAL SOLUTION, USP
FLUOXETINE DELAYED-RELEASE CAPSULES, USP
WARNING
6
Suicidality and Antidepressant Drugs — Antidepressants increased the risk compared to
7
placebo of suicidal thinking and behavior (suicidality) in children, adolescent... | custom-source | 2025-02-12T13:45:04.467692 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf', 'application_number': 18936, 'submission_type': 'SUPPL ', 'submission_number': 82} |
11,373 |
1
1
2
3
4
5
PV 5324 DPP
PROZAC®
FLUOXETINE CAPSULES, USP
FLUOXETINE ORAL SOLUTION, USP
FLUOXETINE DELAYED-RELEASE CAPSULES, USP
WARNING
6
Suicidality and Antidepressant Drugs — Antidepressants increased the risk compared to
7
placebo of suicidal thinking and behavior (suicidality) in children, adolescent... | custom-source | 2025-02-12T13:45:04.469980 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf', 'application_number': 18936, 'submission_type': 'SUPPL ', 'submission_number': 81} |
11,375 |
1
PV 5326 DPP
1
PROZAC®
2
FLUOXETINE CAPSULES, USP
3
FLUOXETINE ORAL SOLUTION, USP
4
FLUOXETINE DELAYED-RELEASE CAPSULES, USP
5
WARNING
6
Suicidality and Antidepressant Drugs — Antidepressants increased the risk compared to
7
placebo of suicidal thinking and behavior (suicidality) in children, adolescen... | custom-source | 2025-02-12T13:45:04.734519 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s084,020101s039,021235s011lbl.pdf', 'application_number': 18936, 'submission_type': 'SUPPL ', 'submission_number': 84} |
11,376 |
1
PV 5971 UCP
SARAFEM®
fluoxetine hydrochloride
WARNING
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 disorder (MDD) a... | custom-source | 2025-02-12T13:45:05.681581 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s086lbl.pdf', 'application_number': 18936, 'submission_type': 'SUPPL ', 'submission_number': 86} |
11,378 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
Thes... | custom-source | 2025-02-12T13:45:06.000149 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091lbl.pdf', 'application_number': 18936, 'submission_type': 'SUPPL ', 'submission_number': 91} |
11,377 |
1
1.0 NL PV 5327 DPP
2
PROZAC®
3
FLUOXETINE CAPSULES, USP
4
FLUOXETINE ORAL SOLUTION, USP
5
FLUOXETINE DELAYED-RELEASE CAPSULES, USP
6
WARNING
7
Suicidality and Antidepressant Drugs — Antidepressants increased the risk compared to
8
placebo of suicidal thinking and behavior (suicidality) in... | custom-source | 2025-02-12T13:45:06.001980 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s088,020101s042,021235s014lbl.pdf', 'application_number': 18936, 'submission_type': 'SUPPL ', 'submission_number': 88} |
11,384 | Document Information Page
This page is for FDA internal use only. Do NOT send this page with the letter.
Application #(s):
NDA 18-961/S-012
Document Type:
Supplement Letter
Document Group:
Approval Letters
Document Name:
Approval letter based on enclosed/submitted labeling text
Letter Code:
SNDA-I1
COMIS Decision:
AP:... | custom-source | 2025-02-12T13:45:06.787163 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18961s12lbl.pdf', 'application_number': 18961, 'submission_type': 'SUPPL ', 'submission_number': 12} |
11,379 |
Bipolar I Disorder
fluoxetine once daily (initial
mg of oral
(2.5)
dose)
olanzapine and 20
mg of fluoxetine
once daily (initial
dose)
Treatment
Oral in co... | custom-source | 2025-02-12T13:45:06.982367 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf', 'application_number': 18936, 'submission_type': 'SUPPL ', 'submission_number': 100} |
11,385 |
1
1
EC-NAPROSYN® (naproxen delayed-release tablets)
2
NAPROSYN® (naproxen tablets)
3
ANAPROX®/ANAPROX®DS (naproxen sodium tablets)
4
NAPROSYN®(naproxen suspension)
5
Rx only
6
7
8
9
DESCRIPTION
10
Naproxen is a member of the arylacetic acid group of nonsteroidal anti-inflammatory
11
d... | custom-source | 2025-02-12T13:45:07.232912 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf', 'application_number': 18965, 'submission_type': 'SUPPL ', 'submission_number': 10} |
11,380 |
... | custom-source | 2025-02-12T13:45:07.720339 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s102lbl.pdf', 'application_number': 18936, 'submission_type': 'SUPPL ', 'submission_number': 102} |
11,387 | NDA 17-581/S-106, 18-164/S-056, 18-965/S-014, 20-067/S-011
Page 3
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 car... | custom-source | 2025-02-12T13:45:07.764955 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf', 'application_number': 18965, 'submission_type': 'SUPPL ', 'submission_number': 14} |
11,386 | 1
1
EC-NAPROSYN® (naproxen delayed-release tablets)
2
NAPROSYN® (naproxen tablets)
3
ANAPROX®/ANAPROX® DS (naproxen sodium tablets)
4
NAPROSYN® (naproxen suspension)
5
Rx only
6
Cardiovascular Risk
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic
events, myocardial infarction, ... | custom-source | 2025-02-12T13:45:07.838874 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,018164s055, 017581s105lbl.pdf', 'application_number': 18965, 'submission_type': 'SUPPL ', 'submission_number': 13} |
11,390 | 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 | 2025-02-12T13:45:08.638615 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf', 'application_number': 18965, 'submission_type': 'SUPPL ', 'submission_number': 20} |
11,389 |
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 | 2025-02-12T13:45:08.990980 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf', 'application_number': 18965, 'submission_type': 'SUPPL ', 'submission_number': 18} |
11,388 | (RoChe)
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 | 2025-02-12T13:45:09.125744 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf', 'application_number': 18965, 'submission_type': 'SUPPL ', 'submission_number': 16} |
11,391 |
NAPROSYN (naproxen) Suspension
Rx only
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND
GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious cardi... | custom-source | 2025-02-12T13:45:09.210974 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018965s022s023lbl.pdf', 'application_number': 18965, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,392 | NDA 18-972/S-030
Page 3
Cordarone
(amiodarone HCl)
TABLETS
Rx only
DESCRIPTION
Cordarone is a member of a new class of antiarrhythmic drugs with predominantly Class III (Vaughan
Williams’ classification) effects, available for oral administration as pink, scored tablets containing
200 mg of amioda... | custom-source | 2025-02-12T13:45:09.389917 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18972s030lbl.pdf', 'application_number': 18972, 'submission_type': 'SUPPL ', 'submission_number': 30} |
11,394 |
NDA 18-972/S-038/039
Page 3
Cordarone®
(amiodarone HCl)
Tablets
Rx only
DESCRIPTION
Cordarone (amiodarone HCl) is a member of a new class of antiarrhythmic drugs with
predominantly Class III (Vaughan Williams' classification) effects, available for oral
administr... | custom-source | 2025-02-12T13:45:09.727490 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf', 'application_number': 18972, 'submission_type': 'SUPPL ', 'submission_number': 39} |
11,393 |
NDA 18-972/S-038/039
Page 3
Cordarone®
(amiodarone HCl)
Tablets
Rx only
DESCRIPTION
Cordarone (amiodarone HCl) is a member of a new class of antiarrhythmic drugs with
predominantly Class III (Vaughan Williams' classification) effects, available for oral
administr... | custom-source | 2025-02-12T13:45:09.747651 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf', 'application_number': 18972, 'submission_type': 'SUPPL ', 'submission_number': 38} |
11,395 |
Cordarone®
(amiodarone HCl)
TABLETS
Rx only
DESCRIPTION
Cordarone (amiodarone HCl) is a member of a new class of antiarrhythmic drugs with
predominantly Class III (Vaughan Williams' classification) effects, available for oral
administration as pink, scored tablets containing 200 mg of amiodarone hydrochloride.... | custom-source | 2025-02-12T13:45:09.858271 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s041lbl.pdf', 'application_number': 18972, 'submission_type': 'SUPPL ', 'submission_number': 41} |
11,396 |
Cordarone®
(amiodarone HCl)
TABLETS
Rx only
DESCRIPTION
Cordarone (amiodarone HCl) is a member of a class of antiarrhythmic drugs with
predominantly Class III (Vaughan Williams’ classification) effects, available for oral
administration as pink, scored tablets containing 200 mg of amiodarone hydro... | custom-source | 2025-02-12T13:45:09.906917 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018972s042lbl.pdf', 'application_number': 18972, 'submission_type': 'SUPPL ', 'submission_number': 42} |
11,397 |
1
Cordarone®
(amiodarone HCl)
TABLETS
DESCRIPTION
Cordarone (amiodarone HCl) is a member of a class of antiarrhythmic drugs with
predominantly Class III (Vaughan Williams’ classification) effects, available for oral
administration as pink, scored tablets containing 200 mg of amiodarone hydrochloride. The
inact... | custom-source | 2025-02-12T13:45:10.138518 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018972s047lbl.pdf', 'application_number': 18972, 'submission_type': 'SUPPL ', 'submission_number': 47} |
11,399 |
Cordarone®
(amiodarone HCl)
TABLETS
DESCRIPTION
Cordarone (amiodarone HCl) is a member of a class of antiarrhythmic drugs with
predominantly Class III (Vaughan Williams’ classification) effects, available for oral
administ... | custom-source | 2025-02-12T13:45:10.304123 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018972s051lbl.pdf', 'application_number': 18972, 'submission_type': 'SUPPL ', 'submission_number': 51} |
11,400 |
levatol® tablets
(penbutolol sulfate)
20 mg
Rx Only
DESCRIPTION
levatol® (penbutolol sulfate) is a synthetic ß-receptor antagonist for oral administration. The
chemical name of penbutolol sulfate is (S)-1-tert-butylamino-3-(o-cyclopentylphenoxy)-2
propanol sulfate. It is provided as... | custom-source | 2025-02-12T13:45:10.348556 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018976s012lbl.pdf', 'application_number': 18976, 'submission_type': 'SUPPL ', 'submission_number': 12} |
11,401 | *
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 | 2025-02-12T13:45:10.724713 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf', 'application_number': 18985, 'submission_type': 'SUPPL ', 'submission_number': 53} |
11,398 |
Cordarone®
(amiodarone HCl)
TABLETS
DESCRIPTION
Cordarone (amiodarone HCl) is a member of a class of antiarrhythmic drugs with
predominantly Class III (Vaughan Williams’ classification) effects, available for oral
administrati... | custom-source | 2025-02-12T13:45:10.847563 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018972s050lbl.pdf', 'application_number': 18972, 'submission_type': 'SUPPL ', 'submission_number': 50} |
11,402 | 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 | 2025-02-12T13:45:11.105803 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,018985s063lbl.pdf', 'application_number': 18985, 'submission_type': 'SUPPL ', 'submission_number': 63} |
11,405 | 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 | 2025-02-12T13:45:11.141576 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18989scp056_advil_lbl.pdf', 'application_number': 18989, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,404 | 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 | 2025-02-12T13:45:11.153089 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18989scp056_advil_lbl.pdf', 'application_number': 18989, 'submission_type': 'SUPPL ', 'submission_number': 55} |
11,403 | 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 | 2025-02-12T13:45:11.275670 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18989s53lbl.pdf', 'application_number': 18989, 'submission_type': 'SUPPL ', 'submission_number': 53} |
11,408 | ----------
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can
cause injury and even death to the developing fetus. When pregnancy is detected,
VASOTEC should be discontinued as soon as possible. (See WARNINGS,
Fetal/Neonatal Morbidity and Mortality).
V... | custom-source | 2025-02-12T13:45:11.411237 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018998s071lbl.pdf', 'application_number': 18998, 'submission_type': 'SUPPL ', 'submission_number': 71} |
11,407 | 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 | 2025-02-12T13:45:11.466588 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018989Orig1s084lbl.pdf', 'application_number': 18989, 'submission_type': 'SUPPL ', 'submission_number': 84} |
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