id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
10,986 |
6000
PRODUCT
6200
INFORMATION
PROGLYCEM®
brand of diazoxide
Capsules
Suspension, USP
FOR ORAL ADMINISTRATION
Rx ... | custom-source | 2025-02-12T13:44:10.670713 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017425s016lbl.pdf', 'application_number': 17425, 'submission_type': 'SUPPL ', 'submission_number': 16} |
10,984 |
----------
NDA 17407/S-036
Page 4
CATAPRES - clonidine hydrochloride tablet
Boehringer Ingelheim Pharmaceuticals Inc.
Catapres
(clonidine hydrochloride, USP)
Oral Antihypertensive
Tablets of 0.1, 0.2 and 0.3 mg
Prescribing Information
DESCRIPTION
Catapres (c... | custom-source | 2025-02-12T13:44:10.707382 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017407s036lbl.pdf', 'application_number': 17407, 'submission_type': 'SUPPL ', 'submission_number': 36} |
10,987 | 1
NSS-9A (O)
NegGram ®
Suspension1
NALIDIXIC ACID
ORAL SUSPENSION1, USP
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
NegGram (nalidixic acid, USP) and other antibacterial drugs, NegGram should be used only to
treat or prevent infections that are proven or strongly suspected to ... | custom-source | 2025-02-12T13:44:10.767850 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf', 'application_number': 17430, 'submission_type': 'SUPPL ', 'submission_number': 28} |
10,988 | 1
NSS-9A (O)
NegGram ®
Suspension1
NALIDIXIC ACID
ORAL SUSPENSION1, USP
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
NegGram (nalidixic acid, USP) and other antibacterial drugs, NegGram should be used only to
treat or prevent infections that are proven or strongly suspected to ... | custom-source | 2025-02-12T13:44:10.888072 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf', 'application_number': 17430, 'submission_type': 'SUPPL ', 'submission_number': 30} |
10,989 |
Minipress®
Capsules
(prazosin hydrochloride)
For Oral Use
DESCRIPTION
MINIPRESS® (prazosin hydrochloride), a quinazoline derivative, is the first of a new
chemical class of antihypertensives. It is the hydrochloride salt of
1-(4-amino-6,7-dimethoxy- 2-quinazolinyl)-4-... | custom-source | 2025-02-12T13:44:11.213513 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017442s035lbl.pdf', 'application_number': 17442, 'submission_type': 'SUPPL ', 'submission_number': 35} |
10,990 |
Minipress®
Capsules
(prazosin hydrochloride)
For Oral Use
DESCRIPTION
MINIPRESS® (prazosin hydrochloride), a quinazoline derivative, is the first of a new ch... | custom-source | 2025-02-12T13:44:11.231947 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017442s041lbl.pdf', 'application_number': 17442, 'submission_type': 'SUPPL ', 'submission_number': 41} |
10,992 |
NDA 17443/S-/S-043/S-046/S-048/S-049
Page 7
Dantrium (dantrolene sodium) capsules
Dantrium (dantrolene sodium) has a potential for hepatotoxicity, and should not be used
in conditions other than those recommended. Symptomatic hepatitis (fatal and non
fatal) has been reported at... | custom-source | 2025-02-12T13:44:11.319941 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf', 'application_number': 17443, 'submission_type': 'SUPPL ', 'submission_number': 43} |
10,991 |
Minipress®
Capsules
(prazosin hydrochloride)
For Oral Use
DESCRIPTION
MINIPRESS® (prazosin hydrochloride), a quinazoline derivative, is the first of a new chemical
class of antihypertensives. It is the hydrochloride sa... | custom-source | 2025-02-12T13:44:11.324651 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017442 s043lbl.pdf', 'application_number': 17442, 'submission_type': 'SUPPL ', 'submission_number': 43} |
10,994 |
NDA 17443/S-/S-043/S-046/S-048/S-049
Page 7
Dantrium (dantrolene sodium) capsules
Dantrium (dantrolene sodium) has a potential for hepatotoxicity, and should not be used
in conditions other than those recommended. Symptomatic hepatitis (fatal and non
fatal) has been reported at... | custom-source | 2025-02-12T13:44:11.530021 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf', 'application_number': 17443, 'submission_type': 'SUPPL ', 'submission_number': 48} |
10,993 |
NDA 17443/S-/S-043/S-046/S-048/S-049
Page 7
Dantrium (dantrolene sodium) capsules
Dantrium (dantrolene sodium) has a potential for hepatotoxicity, and should not be used
in conditions other than those recommended. Symptomatic hepatitis (fatal and non
fatal) has been reported at... | custom-source | 2025-02-12T13:44:11.564029 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf', 'application_number': 17443, 'submission_type': 'SUPPL ', 'submission_number': 46} |
10,996 | NDA 17-463/S-104
Page 3
Motrin®
Ibuprofen Tablets, USP
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 f... | custom-source | 2025-02-12T13:44:11.739205 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017463s104lbl.pdf', 'application_number': 17463, 'submission_type': 'SUPPL ', 'submission_number': 104} |
10,997 | NDA 17-468/S-019
NDA 17-469/S-031
Page 3
Packaging Insert
1/8% Econopred
1 % Econopred
Plus
(prednisolone acetate ophthalmic suspension)
DESCRIPTION: ECONOPRED and ECONOPRED Plus (Prednisolone Acetate ophthalmic
suspension) are adrenocortical steroid products prepared as sterile ophthalmi... | custom-source | 2025-02-12T13:44:11.912727 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17468slr019,17469slr031_econopred_lbl.pdf', 'application_number': 17468, 'submission_type': 'SUPPL ', 'submission_number': 19} |
10,998 | NDA 17-469/S-040
Page 3
Omnipred™ (prednisolone acetate ophthalmic suspension)
DESCRIPTION: Omnipred™ (prednisolone acetate ophthalmic suspension) is an adrenocortical
steroid product prepared as sterile ophthalmic suspension. The active ingredient is represented by the
chemical structure:
--- CHEMICAL ST... | custom-source | 2025-02-12T13:44:11.987445 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017469s040lbl.pdf', 'application_number': 17469, 'submission_type': 'SUPPL ', 'submission_number': 40} |
10,999 |
1
XXXXXX
ORAP® (Pimozide)
Tablets
GATE
151
187
DESCRIPTION
ORAP
® (pimozide) is an orally active antipsychotic agent of the diphenyl-butylpiperidine
series.
The structural formula of pimozide, 1-[1-[4,4-bis(4-fluorophenyl) butyl]-4
piperidinyl]-1,3-dihydro-2H-benzimida... | custom-source | 2025-02-12T13:44:12.402493 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017473s045lbl.pdf', 'application_number': 17473, 'submission_type': 'SUPPL ', 'submission_number': 45} |
11,001 | Reference ID: 3032878
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Reference ID: 3032878
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 | 2025-02-12T13:44:12.413576 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017478s014lbl.pdf', 'application_number': 17478, 'submission_type': 'SUPPL ', 'submission_number': 14} |
11,000 |
1
XXXXXX
ORAP® (Pimozide)
Tablets
GATE
151
187
DESCRIPTION
ORAP
® (pimozide) is an orally active antipsychotic agent of the diphenyl-butylpiperidine
series.
The structural formula of pimozide, 1-[1-[4,4-bis(4-fluorophenyl) butyl]-4
piperidinyl]-1,3-dihydro-2H-benzimida... | custom-source | 2025-02-12T13:44:12.422184 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017473s046lbl.pdf', 'application_number': 17473, 'submission_type': 'SUPPL ', 'submission_number': 46} |
11,003 | Reference ID: 3296493
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Reference ID: 3296493
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 | 2025-02-12T13:44:12.878019 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017512s113,020163s020,020183s019lbl.pdf', 'application_number': 17512, 'submission_type': 'SUPPL ', 'submission_number': 113} |
11,002 |
DIANEAL PD-2 Peritoneal Dialysis Solution
AMBU-FLEX Container For Peritoneal Dialysis
For intraperitoneal administration only
Description
DIANEAL PD-2 peritoneal dialysis solutions in AMBU-FLEX containers are
sterile, nonpyrogenic solutions for intraperitoneal administration only. They
con... | custom-source | 2025-02-12T13:44:13.207089 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017512s108lbl.pdf', 'application_number': 17512, 'submission_type': 'SUPPL ', 'submission_number': 108} |
11,004 |
DIANEAL Peritoneal Dialysis Solution
For intraperitoneal administration only
DIANEA... | custom-source | 2025-02-12T13:44:13.237753 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s120s121lbl.pdf', 'application_number': 17512, 'submission_type': 'SUPPL ', 'submission_number': 120} |
10,995 | 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 | 2025-02-12T13:44:13.397018 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf', 'application_number': 17451, 'submission_type': 'SUPPL ', 'submission_number': 58} |
11,005 |
DIANEAL Peritoneal Dialysis Solution
For intraperitoneal administration only
DIANEA... | custom-source | 2025-02-12T13:44:13.774906 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s122,020163s027,020183s026lbl.pdf', 'application_number': 17512, 'submission_type': 'SUPPL ', 'submission_number': 122} |
11,007 |
Dextrose Injection, USP
in AVIVA Plastic Container
DESCRIPTION
Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid replenishment and
caloric supply in single dose containers for intra... | custom-source | 2025-02-12T13:44:14.035743 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf', 'application_number': 17521, 'submission_type': 'SUPPL ', 'submission_number': 68} |
11,008 | 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 | 2025-02-12T13:44:14.256639 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf', 'application_number': 17522, 'submission_type': 'SUPPL ', 'submission_number': 23} |
11,006 |
SINEQUAN®
(doxepin HCl)
CAPSULES
ORAL CONCENTRATE
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior
(suicidality) in children, adolescents, and ... | custom-source | 2025-02-12T13:44:14.278037 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016798s056,017516s025lbl.pdf', 'application_number': 17516, 'submission_type': 'SUPPL ', 'submission_number': 25} |
11,009 | 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 | 2025-02-12T13:44:14.567065 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf', 'application_number': 17522, 'submission_type': 'SUPPL ', 'submission_number': 26} |
11,011 | Tigan®
(trimethobenzamide hydrochloride)
Capsules/Suppositories/Injectable
DESCRIPTION
Chemically, trimethobenzamide HCl is N-[p-[2-(dimethylamino)ethoxy]benzyl]-
3,4,5-trimethoxybenz- amide monohydrochloride. It has a molecular weight of
424.93 and the following structural formula:
(CH3)2N-CH2CH2O
CH2NHC
OCH3
... | custom-source | 2025-02-12T13:44:14.928094 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf', 'application_number': 17530, 'submission_type': 'SUPPL ', 'submission_number': 21} |
11,013 |
NDA 17-530/S-024
Page 3
Tigan®
(trimethobenzamide hydrochloride)
Injectable
For Intramuscular Use Only
Not for Use in Pediatric Patients
DESCRIPTION
Chemically,
trimethobenzamide
HCl
is
N-[p-[2-(dimethylamino)ethoxy]benzyl]-3,... | custom-source | 2025-02-12T13:44:14.930791 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017530s024lbl.pdf', 'application_number': 17530, 'submission_type': 'SUPPL ', 'submission_number': 24} |
11,010 | NDA 17-531/S-010
Tigan®
(trimethobenzamide hydrochloride)
Capsules/Suppositories/Injectable
DESCRIPTION
Chemically, trimethobenzamide HCl is N-[p-[2-(dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide
monohydrochloride. It has a molecular weight of 424.93 and the following structural formula:
(CH3)2N-CH2CH2O
CH2N... | custom-source | 2025-02-12T13:44:14.931407 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17531s10lbl.pdf', 'application_number': 17530, 'submission_type': 'SUPPL ', 'submission_number': 18} |
11,012 | Tigan®
(trimethobenzamide hydrochloride)
Capsules/Suppositories/Injectable
DESCRIPTION
Chemically, trimethobenzamide HCl is N-[p-[2-(dimethylamino)ethoxy]benzyl]-
3,4,5-trimethoxybenz- amide monohydrochloride. It has a molecular weight of
424.93 and the following structural formula:
(CH3)2N-CH2CH2O
CH2NHC
OCH3
... | custom-source | 2025-02-12T13:44:14.941224 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf', 'application_number': 17530, 'submission_type': 'SUPPL ', 'submission_number': 23} |
11,017 |
Str
uctural F
ormula
Diaßeta® (glyburide) Tablets USP
1.25, 2.5 and 5 mg
DESCRIPTION
Diaßeta® (glyburide) is an oral blood-glucose-lowering drug of the sulfonylurea class. It is a
white, crystalline compound, formulated as tablets of 1.25 mg, 2.5 mg, and 5 mg... | custom-source | 2025-02-12T13:44:15.299363 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s030lbl.pdf', 'application_number': 17532, 'submission_type': 'SUPPL ', 'submission_number': 30} |
11,014 | NDA 17-531/S-010
Tigan®
(trimethobenzamide hydrochloride)
Capsules/Suppositories/Injectable
DESCRIPTION
Chemically, trimethobenzamide HCl is N-[p-[2-(dimethylamino)ethoxy]benzyl]-3,4,5-
trimethoxybenzamide monohydrochloride. It has a molecular weight of 424.93 and the following
structural formula:
(CH3)2N-... | custom-source | 2025-02-12T13:44:15.401714 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17531S010lbl.pdf', 'application_number': 17531, 'submission_type': 'SUPPL ', 'submission_number': 10} |
11,015 | NDA 17-531/S-012
Page 3
Tigan®
(trimethobenzamide hydrochloride)
Capsules
DESCRIPTION
Chemically, trimethobenzamide HCl is N-[p-[2-(dimethylamino)ethoxy]benzyl]-3,4,5-
trimethoxybenzamide monohydrochloride. It has a molecular weight of 424.93 and the
following structural formula:
(CH3)2N-CH2CH2O
CH2NHC
OCH... | custom-source | 2025-02-12T13:44:15.426711 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017531s012lbl.pdf', 'application_number': 17531, 'submission_type': 'SUPPL ', 'submission_number': 12} |
11,016 |
Che
mical Str
ucture
Diaßeta®
(glyburide USP)
Tablets 1.25, 2.5 and 5 mg
DESCRIPTION
Diaßeta® (glyburide USP) is an oral blood-glucose-lowering drug of the sulfonylurea class. It is a
white, crystalline compound, formulated as tablets of 1.25 mg, 2.5 mg, and 5 mg strengths... | custom-source | 2025-02-12T13:44:15.490456 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s027s028lb.pdf', 'application_number': 17532, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,018 |
Diaßeta® (glyburide) Tablets USP
1.25, 2.5 and 5 mg
DESCRIPTION
Diaßeta® (glyburide) is an oral blood-glucose-lowering drug of the sulfonylurea class. It is a
white, crystal... | custom-source | 2025-02-12T13:44:15.785019 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017532Orig1s034lbl.pdf', 'application_number': 17532, 'submission_type': 'SUPPL ', 'submission_number': 34} |
11,021 | SCH 11460
SECTION 2
DIPROSONE CREAM PAGE 1 DRAFT LABELING
XXXXXXXX
PRODUCT INFORMATION
DIPROSONE®
brand of betamethasone
dipropionate
Cream, USP 0.05%
(potency expressed as betamethasone)
For ... | custom-source | 2025-02-12T13:44:15.993078 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17536s18lbl.pdf', 'application_number': 17536, 'submission_type': 'SUPPL ', 'submission_number': 18} |
11,019 |
Roche Logo
KLONOPIN® TABLETS
(clonazepam)
KLONOPIN® WAFERS
(clonazepam orally disintegrating tablets)
Rx only
DESCRIPTION
Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation
containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation ... | custom-source | 2025-02-12T13:44:16.038734 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017533s045,020813s005lbl.pdf', 'application_number': 17533, 'submission_type': 'SUPPL ', 'submission_number': 45} |
11,020 |
NDA 017533 Klonopin (clonazepam) tablets
FDA Approved Labeling Text October 2013
KLONOPIN TABLETS
(clonazepam)
Rx only
DESCRIPTION
Klonopin, a benzodiazepine, is available as scored tablets with ... | custom-source | 2025-02-12T13:44:16.263633 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017533s053,020813s009lbl.pdf', 'application_number': 17533, 'submission_type': 'SUPPL ', 'submission_number': 53} |
11,022 |
SINEMET
®
(carbidopa levodopa)
Tablets
DESCRIPTION
SINEMET® (carbidopa levodopa) is a combination of carbidopa and levodopa for the treatment of... | custom-source | 2025-02-12T13:44:16.327050 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf', 'application_number': 17555, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,024 |
SINEMET
®
(carbidopa levodopa)
Tablets
DESCRIPTION
SINEMET® (carbidopa levodopa) is a combination of carbidopa and levodopa for the treatment of... | custom-source | 2025-02-12T13:44:16.381415 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf', 'application_number': 17555, 'submission_type': 'SUPPL ', 'submission_number': 71} |
11,023 |
s
tru
ctur
al formul
a
s
tru
ctu
ral formula
FDA Approved Labeling Text for NDA 017555
Dated 1/31/11 company logo
SINEMET®
(carbidopa-levodopa)
Tablets
DESCRIPTION
SINEMET® (carbidopa-levodopa) is a combination of carbidopa and levodopa for the treatment of
Parkinson's disease and syndrome. ... | custom-source | 2025-02-12T13:44:16.432782 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017555s070lbl.pdf', 'application_number': 17555, 'submission_type': 'SUPPL ', 'submission_number': 70} |
11,027 |
DANOCRINE®
Brand of DANAZOL
CAPSULES, USP
DESCRIPTION
DANOCRINE, brand of danazol, is a synthetic steroid derived from ethisterone. It is a
white to pale yellow crystalline powder, practically insoluble or insoluble in water, and
sparingly soluble in alcohol. Chemically, danazol is 17... | custom-source | 2025-02-12T13:44:16.709717 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf', 'application_number': 17557, 'submission_type': 'SUPPL ', 'submission_number': 40} |
11,026 |
DANOCRINE®
Brand of DANAZOL
CAPSULES, USP
DESCRIPTION
DANOCRINE, brand of danazol, is a synthetic steroid derived from ethisterone. It is a
white to pale yellow crystalline powder, practically insoluble or insoluble in water, and
sparingly soluble in alcohol. Chemically, danazol is 17... | custom-source | 2025-02-12T13:44:16.728148 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf', 'application_number': 17557, 'submission_type': 'SUPPL ', 'submission_number': 33} |
11,025 |
----------
HALOG®(Halcinonide Cream, USP) 0.1%
Page 1 of 6
HALOG - halcinonide cream
®
HALOG
(Halcinonide Cream, USP) 0.1%
For Topical Use Only. Not For Ophthalmic, Oral or Intravaginal Use.
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti... | custom-source | 2025-02-12T13:44:16.755899 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017556s038lbl.pdf', 'application_number': 17556, 'submission_type': 'SUPPL ', 'submission_number': 38} |
11,031 |
DITROPAN®
(oxybutynin chloride)
Tablets
DESCRIPTION
Each scored biconvex, engraved blue DITROPAN® (oxybutynin chloride) Tablet
contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d,l
(racemic) 4-diethylamino-2-butynyl phenylcyclohexylg... | custom-source | 2025-02-12T13:44:17.174390 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017577s035lbl.pdf', 'application_number': 17577, 'submission_type': 'SUPPL ', 'submission_number': 35} |
11,029 | 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 | 2025-02-12T13:44:17.175908 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf', 'application_number': 17577, 'submission_type': 'SUPPL ', 'submission_number': 33} |
11,030 |
1
DITROPAN®
(oxybutynin chloride)
Tablets and Syrup
DESCRIPTION
Each scored biconvex, engraved blue DITROPAN® (oxybutynin chloride) Tablet
contains 5 mg of oxybutynin chloride. Each 5 mL of DITROPAN Syrup contains
5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d,l (racemic)
4-diethylamino-2... | custom-source | 2025-02-12T13:44:17.352613 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,020897s018lbl.pdf', 'application_number': 17577, 'submission_type': 'SUPPL ', 'submission_number': 34} |
11,028 |
28-Day Regimen
Rx only Product Logo
Patients should be counseled that this product does not protect against HIV-infection (AIDS) and
other sexually transmitted diseases.
Description
OVCON® 50, 28-Day (norethindrone and ethinyl estradiol tab... | custom-source | 2025-02-12T13:44:17.378595 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017576s051lbl.pdf', 'application_number': 17576, 'submission_type': 'SUPPL ', 'submission_number': 51} |
11,032 |
DITROPAN
(oxybutynin chloride)
Tablets
DESCRIPTION
Each scored biconvex, engraved blue DITROPAN (oxybutynin chloride) Tablet
contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d,l
(racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The
empirical formula of oxybut... | custom-source | 2025-02-12T13:44:17.678835 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017577s036lbl.pdf', 'application_number': 17577, 'submission_type': 'SUPPL ', 'submission_number': 36} |
11,033 |
DITROPAN
(oxybutynin chloride)
Tablets
DESCRIPTION
Each scored biconvex, engraved blue DITROPAN (oxybutynin chloride) Tablet
contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d,l
(racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The
empirical formu... | custom-source | 2025-02-12T13:44:17.749414 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017577s037lbl.pdf', 'application_number': 17577, 'submission_type': 'SUPPL ', 'submission_number': 37} |
11,034 |
DITROPAN
(oxybutynin chloride)
Tablets
DESCRIPTION
Each scored biconvex, engraved blue DITROPAN (oxybutynin chloride) Tablet
contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d,l
(racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The
empirical formu... | custom-source | 2025-02-12T13:44:17.794438 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017577s038lbl.pdf', 'application_number': 17577, 'submission_type': 'SUPPL ', 'submission_number': 38} |
11,035 |
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 | 2025-02-12T13:44:18.248135 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf', 'application_number': 17581, 'submission_type': 'SUPPL ', 'submission_number': 99} |
11,037 | 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 | 2025-02-12T13:44:18.545468 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf', 'application_number': 17581, 'submission_type': 'SUPPL ', 'submission_number': 106} |
11,036 | 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 | 2025-02-12T13:44:18.556546 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,018164s055, 017581s105lbl.pdf', 'application_number': 17581, 'submission_type': 'SUPPL ', 'submission_number': 105} |
11,038 | (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 | 2025-02-12T13:44:18.662381 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf', 'application_number': 17581, 'submission_type': 'SUPPL ', 'submission_number': 108} |
11,041 |
LOMUSTINE - lomustine capsule, gelatin coated
NextSource Biotechnology, LLC
Lomustine
Capsules
WARNINGS
Lomustine should be administered under the supervision of a qualified physician experienced in the use of cancer
chemotherapeutic agents.
Bone marrow suppression, notably thrombocytopenia and leukopenia, w... | custom-source | 2025-02-12T13:44:18.859654 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017588s039lbl.pdf', 'application_number': 17588, 'submission_type': 'SUPPL ', 'submission_number': 39} |
11,039 |
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 | 2025-02-12T13:44:19.009906 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf', 'application_number': 17581, 'submission_type': 'SUPPL ', 'submission_number': 110} |
11,040 |
CeeNU
(lomustine)
Capsules
WARNINGS
CeeNU (lomustine) should be administered under the supervision of a qualified physician
experienced in the use of cancer chemotherapeutic agents.
Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to
bleeding and overwhelming infe... | custom-source | 2025-02-12T13:44:19.013499 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017588s036lbl.pdf', 'application_number': 17588, 'submission_type': 'SUPPL ', 'submission_number': 36} |
11,042 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not in... | custom-source | 2025-02-12T13:44:19.070281 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017588s042lbl.pdf', 'application_number': 17588, 'submission_type': 'SUPPL ', 'submission_number': 42} |
11,043 | 1
SEPTRA
® Tablets
SEPTRA
® DS (Double Strength) Tablets
SEPTRA
® Suspension
SEPTRA
® Grape Suspension
(trimethoprim and sulfamethoxazole)
DESCRIPTION: SEPTRA (trimethoprim and sulfamethoxazole) is a
synthetic antibacterial combination product. Each SEPTRA
Tablet contains 80 mg trimethoprim and 400 mg sulfa... | custom-source | 2025-02-12T13:44:19.139469 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017376s056,017598s039lbl.pdf', 'application_number': 17598, 'submission_type': 'SUPPL ', 'submission_number': 39} |
11,045 | NDA 17-604/S-040
Page 3
NALFON®
(fenoprofen calcium capsules, USP)
200 mg & 300mg
Rx only
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... | custom-source | 2025-02-12T13:44:19.453616 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017604s040lbl.pdf', 'application_number': 17604, 'submission_type': 'SUPPL ', 'submission_number': 40} |
11,044 | Septra Tablets (trimethoprim and sulfamethoxazole tablets) Tablet
Septra Ds Tablets (trimethoprim and sulfamethoxazole ds tablets) Tablet
Septra Suspension (trimethoprim and sulfamethoxazole suspension) Suspension
Septra Grape Suspension (trimethoprim and sulfamethoxazole grape suspension) Suspension
To red... | custom-source | 2025-02-12T13:44:19.643705 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017376s059,017598s041lbl.pdf', 'application_number': 17598, 'submission_type': 'SUPPL ', 'submission_number': 41} |
11,046 | NALFONCI
(fenoprofen calcium capsules, USP)
200 mg
Rx onl y
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 c... | custom-source | 2025-02-12T13:44:19.648547 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017604s041lbl.pdf', 'application_number': 17604, 'submission_type': 'SUPPL ', 'submission_number': 41} |
11,047 |
NALFON®
(fenoprofen calcium capsules, USP)
200 mg and 400 mg
Rx only
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 | 2025-02-12T13:44:19.685600 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017604s043lbl.pdf', 'application_number': 17604, 'submission_type': 'SUPPL ', 'submission_number': 43} |
11,051 | c
o
mp
an
y
logo
4
HEPARIN SODIUM
5
INJECTION, USP
6
Rx only
7
8
DERIVED FROM PORCINE INTESTINAL MUCOSA.
9
Available as: Preservative Free or Contains Benzyl Alcohol or Parabens
10
DESCRIPTION:
11
Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called
12
glyc... | custom-source | 2025-02-12T13:44:19.953471 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017029s120,017651s048lbl.pdf', 'application_number': 17651, 'submission_type': 'SUPPL ', 'submission_number': 48} |
11,049 |
Forane ® (isoflurane, USP)
Proposed Package Insert
FORANE (isoflurane, USP)
Liquid For Inhalation
Rx only
DESCRIPTION
FORANE (isoflurane, USP), a nonflammable liquid administered by vaporizing, is a
general inhalation anesthetic drug. It... | custom-source | 2025-02-12T13:44:20.014610 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017624s036lbl.pdf', 'application_number': 17624, 'submission_type': 'SUPPL ', 'submission_number': 36} |
11,048 |
HIGHLIGHTS ... | custom-source | 2025-02-12T13:44:20.130104 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017604s046lbl.pdf', 'application_number': 17604, 'submission_type': 'SUPPL ', 'submission_number': 46} |
11,050 |
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 | 2025-02-12T13:44:20.145962 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017628s067,018084s051lbl.pdf', 'application_number': 17628, 'submission_type': 'SUPPL ', 'submission_number': 67} |
11,054 | FLORONE®
diflorasone diacetate cream, USP
0.05%
Not For Ophthalmic Use
DESCRIPTION
Each gram of FLORONE Cream contains 0.5 mg
diflorasone diacetate in a cream base.
Chemically, diflorasone diacetate is: 6α,9-Difluoro-
11β, 17, 21-trihydroxy-16β-methylpregna-1,4-diene-
3,20-dione 17,21-diacetate.
The structural formula ... | custom-source | 2025-02-12T13:44:20.471695 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17741slr021lbl.pdf', 'application_number': 17741, 'submission_type': 'SUPPL ', 'submission_number': 21} |
11,055 | NDA 17-741/S-022
Page 3
FLORONE®
diflorasone diacetate cream, USP
0.05%
Not For Ophthalmic Use
DESCRIPTION
Each gram of FLORONE Cream contains 0.5 mg diflorasone diacetate in a cream base.
Chemically, diflorasone diacetate is: 6α,9-Difluoro-11β, 17, 21-trihydroxy-16β-methylpregna-1,4-
diene-3,20-dione... | custom-source | 2025-02-12T13:44:20.555835 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17741slr022_florone_lbl.pdf', 'application_number': 17741, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,053 |
ORTHO-NOVUM® Tablets (norethindrone/ethinyl estradiol)
and MODICON® Tablets (norethindrone/ethinyl estradiol)
WARNINGS: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING
Cigarette smoking increases the risk of serious cardiovascular events from
combination oral contraceptive use. This risk incre... | custom-source | 2025-02-12T13:44:20.656550 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050lbl.pdf', 'application_number': 17735, 'submission_type': 'SUPPL ', 'submission_number': 104} |
11,052 |
DrytecTM
(Technetium Tc99m Generator)
For the Production of Sodium Pertechnetate Tc99m Injection
Diagnostic Radiopharmaceutical
For intraven... | custom-source | 2025-02-12T13:44:20.656942 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017693s029lbl.pdf', 'application_number': 17693, 'submission_type': 'SUPPL ', 'submission_number': 29} |
11,058 | NDA 17-765/S-024
Page 2
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NDA 17-765/S-024
Page 3
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drug... | custom-source | 2025-02-12T13:44:20.853072 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17765scp024_cloderm_lbl.pdf', 'application_number': 17765, 'submission_type': 'SUPPL ', 'submission_number': 24} |
11,057 |
s
truc
tur
al formula
NDA 17-760/S-017
Page 3
FML®
(fluorometholone ophthalmic ointment) 0.1%
sterile
DESCRIPTION
FML® (fluorometholone ophthalmic ointment) 0.1 % is a sterile, topical anti-inflammatory agent
for ophthalmic use.
Chemical Name
Fluorometholone: 9-Fluoro-... | custom-source | 2025-02-12T13:44:20.925511 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017760s017lbl.pdf', 'application_number': 17760, 'submission_type': 'SUPPL ', 'submission_number': 17} |
11,059 | NDA 17-766/S-029
Page 5
Y36-002-547
PACKAGE INSERT
5.4% NephrAmine® (Essential Amino Acid Injection)
Protect from light until use. Rx only
DESCRIPTION
5.4% NephrAmine (Essential Amino Acid Injection) is a sterile, nonpyrogenic solution
containing crystalline essential amino acids... | custom-source | 2025-02-12T13:44:20.972167 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17766scs029_nephramine_lbl.pdf', 'application_number': 17766, 'submission_type': 'SUPPL ', 'submission_number': 29} |
11,056 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
| custom-source | 2025-02-12T13:44:20.981800 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17760s9lbl.pdf', 'application_number': 17760, 'submission_type': 'SUPPL ', 'submission_number': 9} |
11,063 | Ativan®
CIV
(lorazepam)
Tablets
Rx only
DESCRIPTION
Ativan (lorazepam), an antianxiety agent, has the chemical formula, 7-chloro-5-
(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one:
C15H10Cl2N2O2
MW: 321.16
It is a nearly white powder almost insoluble in water. Each A... | custom-source | 2025-02-12T13:44:21.180972 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017794s034s035lbl.pdf', 'application_number': 17794, 'submission_type': 'SUPPL ', 'submission_number': 35} |
11,062 |
GLUCOTROL®
(glipizide)
TABLETS
For Oral Use
DESCRIPTION
GLUCOTROL (glipizide) is an oral blood-glucose-lowering drug of the sulfonylurea class.
The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-
carboxamido)ethyl]phenyl]sulfonyl]u... | custom-source | 2025-02-12T13:44:21.222685 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017783s020lbl.pdf', 'application_number': 17783, 'submission_type': 'SUPPL ', 'submission_number': 20} |
11,060 | NDC 0234-0575-40
Lot number and expiration date printed on bottom of container.
Laundering/Cleaning Instructions.
Chlorhexidine gluconate skin cleansers will cause stains if used with
chlorine releasing products. Rinse completely and use only
non-chlorine detergents. See website for more details.
www.hibiclens.com
5... | custom-source | 2025-02-12T13:44:21.282807 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017768s042lbl.pdf', 'application_number': 17768, 'submission_type': 'SUPPL ', 'submission_number': 42} |
11,061 | SCH 11460
SECTION 2
DIPROSONE LOTION PAGE 1 DRAFT LABELING
XXXXXXXX
PRODUCT
INFORMATION
DIPROSONE®
brand of betamethasone
dipropionate
Lotion, USP 0.05% w/w
(potency expressed as betamethasone)
... | custom-source | 2025-02-12T13:44:21.322443 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17781s15lbl.pdf', 'application_number': 17781, 'submission_type': 'SUPPL ', 'submission_number': 15} |
11,064 |
company logo
Miacalcin®
(calcitonin-salmon)
Injection, Synthetic
Rx only
DESCRIPTION
Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in
mammals and by the ultimobranchial gland of birds and fish.
Miacalcin® (calcitonin-salmon) Injection, Synthetic is... | custom-source | 2025-02-12T13:44:21.524673 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017808s034lbl.pdf', 'application_number': 17808, 'submission_type': 'SUPPL ', 'submission_number': 34} |
11,065 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all t... | custom-source | 2025-02-12T13:44:21.698245 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017808s035lbl.pdf', 'application_number': 17808, 'submission_type': 'SUPPL ', 'submission_number': 35} |
11,066 |
... | custom-source | 2025-02-12T13:44:21.778854 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017808s036lbl.pdf', 'application_number': 17808, 'submission_type': 'SUPPL ', 'submission_number': 36} |
11,067 | NDA 16-059/S-096, 17-814/S-039, 18-332/S-029
Page 3
CAPSULES, ORAL SUSPENSION
and SUPPOSITORIES
INDOCIN®
(INDOMETHACIN)
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... | custom-source | 2025-02-12T13:44:21.827939 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf', 'application_number': 17814, 'submission_type': 'SUPPL ', 'submission_number': 39} |
11,068 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highli... | custom-source | 2025-02-12T13:44:21.996167 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf', 'application_number': 17814, 'submission_type': 'SUPPL ', 'submission_number': 41} |
11,069 |
1
HALOG OINTMENT
(Halcinonide Ointment, 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 d... | custom-source | 2025-02-12T13:44:22.062959 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17824s024lbl.pdf', 'application_number': 17824, 'submission_type': 'SUPPL ', 'submission_number': 24} |
11,070 |
... | custom-source | 2025-02-12T13:44:22.234309 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf', 'application_number': 17830, 'submission_type': 'SUPPL ', 'submission_number': 14} |
11,071 |
... | custom-source | 2025-02-12T13:44:22.371599 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf', 'application_number': 17830, 'submission_type': 'SUPPL ', 'submission_number': 16} |
11,072 |
... | custom-source | 2025-02-12T13:44:22.373197 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf', 'application_number': 17830, 'submission_type': 'SUPPL ', 'submission_number': 19} |
11,073 |
... | custom-source | 2025-02-12T13:44:22.448879 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf', 'application_number': 17830, 'submission_type': 'SUPPL ', 'submission_number': 30} |
11,077 | REGLAN - metoclopramide tablet
Alaven Pharmaceutical LLC
----------
reglan tablets (metoclopramide tablets, USP)
Rx Only
WARNING
TARDIVE DYSKINESIA
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder
that is often irreversible. The risk of developing tardive dyskinesia incr... | custom-source | 2025-02-12T13:44:22.738464 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s052lbl.pdf', 'application_number': 17854, 'submission_type': 'SUPPL ', 'submission_number': 52} |
11,075 |
s
t
ructu
ral formu
l a
Didronel®
(etidronate disodium)
DESCRIPTION:
Didronel® tablets contain 400 mg of etidronate disodium, the disodium salt of (1
hydroxyethylidene) diphosphonic acid, for oral administration. Th... | custom-source | 2025-02-12T13:44:22.844065 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017831s058lbl.pdf', 'application_number': 17831, 'submission_type': 'SUPPL ', 'submission_number': 58} |
11,074 | Procter & Gamble Pharmaceuticals
Revised May 2005
Didronel®
(etidronate disodium)
DESCRIPTION: Didronel tablets contain either 200 mg or 400 mg of etidronate disodium,
the disodium salt of (1-hydroxyethylidene) diphosphonic acid, for oral administration. This
compound, also known as EHDP, regulates bone met... | custom-source | 2025-02-12T13:44:22.861497 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017831s054lbl.pdf', 'application_number': 17831, 'submission_type': 'SUPPL ', 'submission_number': 54} |
11,076 |
reglan® tablets (metoclopramide tablets, USP)
Rx Only
WARNING: TARDIVE DYSKINESIA
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement
disorder that is often irreversible. The risk of developing tardive dyskinesia increases
with duration of treatment and t... | custom-source | 2025-02-12T13:44:22.960566 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s051,021793s004lbl.pdf', 'application_number': 17854, 'submission_type': 'SUPPL ', 'submission_number': 51} |
11,078 |
reglan® tablets (metoclopramide tablets, USP)
Rx Only
WARNING: TARDIVE DYSKINESIA
Treatment with metoclopramide can cause tardive dyskinesia, a serious
movement disorder that is often irreversible. The risk of developing tardive
dyskinesia increases with duration of treatment and total cumulative d... | custom-source | 2025-02-12T13:44:23.120372 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017854s058lbl.pdf', 'application_number': 17854, 'submission_type': 'SUPPL ', 'submission_number': 58} |
11,081 |
Page 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do no... | custom-source | 2025-02-12T13:44:23.246031 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017858Orig1s035lbl.pdf', 'application_number': 17858, 'submission_type': 'SUPPL ', 'submission_number': 35} |
11,079 | Topicort Emollie
®
nt Cream
(desoximetasone) 0.25%
ollient Cream
FOR DERMATOLOGIC USE ONLY.
OR USE IN EYES.
5% and Topicort® LP
orticosteroid
rily synthetic
Each gram of TOPICORT Emollient Cream 0.25% contains 2.5 mg of Desoximetasone
r USP,
ryl Alcohol NF,
Desoximetasone
Water USP,
il USP, Cetostearyl... | custom-source | 2025-02-12T13:44:23.270035 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17856slr024,18309slr013_topicort_lbl.pdf', 'application_number': 17856, 'submission_type': 'SUPPL ', 'submission_number': 24} |
11,082 |
REGLAN Injection (metoclopramide injection, USP)
Rx only
WARNING: TARDIVE DYSKINESIA
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement
disorder that is often irreversible. The risk of developing tardive dyskinesia increases with
duration of treatment and total cumulativ... | custom-source | 2025-02-12T13:44:23.375197 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017862s061lbl.pdf', 'application_number': 17862, 'submission_type': 'SUPPL ', 'submission_number': 61} |
11,080 |
Page 1 of 10
HIGHLIGHTS OF PRESCRIBING INFORMATION
T... | custom-source | 2025-02-12T13:44:23.445654 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017858Orig1s034lbl.pdf', 'application_number': 17858, 'submission_type': 'SUPPL ', 'submission_number': 34} |
11,085 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all... | custom-source | 2025-02-12T13:44:23.669138 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017874s038lbl.pdf', 'application_number': 17874, 'submission_type': 'SUPPL ', 'submission_number': 38} |
11,083 | 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 | 2025-02-12T13:44:23.703337 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/017874s18s27lbl.pdf', 'application_number': 17874, 'submission_type': 'SUPPL ', 'submission_number': 18} |
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