id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
13,825 |
SPORANOX®
(itraconazole)
INJECTION
Congestive Heart Failure: When itraconazole was administered intravenously to
dogs and healthy human volunteers, negative inotropic effects were seen. If signs
or symptoms of congestive heart failure occur during administration of... | custom-source | 2025-02-12T13:51:19.188515 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s022lbl.pdf', 'application_number': 20966, 'submission_type': 'SUPPL ', 'submission_number': 22} |
13,824 |
1
SPORANOX®
(itraconazole)
INJECTION
Congestive Heart Failure: When itraconazole was administered intravenously to
dogs and healthy human volunteers, negative inotropic effects were seen. If signs
or symptoms of congestive heart failure occur during administration of
SPORANOX® (itraconazole) Injection, cont... | custom-source | 2025-02-12T13:51:19.229119 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s017s018s020lbl.pdf', 'application_number': 20966, 'submission_type': 'SUPPL ', 'submission_number': 18} |
13,826 | 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 | 2025-02-12T13:51:19.231462 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20968lbl.pdf', 'application_number': 20968, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,828 | custom-source | 2025-02-12T13:51:19.616028 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-971_Septocaine_prntlbl.pdf', 'application_number': 20971, 'submission_type': 'ORIG ', 'submission_number': 1} | |
14,033 | SUSTIVATM
(efavirenz) capsules
Rx only
DESCRIPTION
SUSTIVA (efavirenz) is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI).
SUSTIVA is available as capsules for oral administration containing either 50 mg, 100 mg, or
200 mg of efavirenz and the following inactive ingredients: lactose monohyd... | custom-source | 2025-02-12T13:51:19.814027 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20972s13lbl.pdf', 'application_number': 20972, 'submission_type': 'SUPPL ', 'submission_number': 13} |
13,829 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
50 cartridges: 1.7 mL each
50 cartridges: 1.7 mL each
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
2 5 ... | custom-source | 2025-02-12T13:51:19.939682 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020971s017lbl.pdf', 'application_number': 20971, 'submission_type': 'SUPPL ', 'submission_number': 17} |
14,034 | NDAs 20-972 and 21-360
Page 2
SUSTIVA®
(efavirenz) capsules and tablets
Rx only
DESCRIPTION
SUSTIVA® (efavirenz) is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside,
reverse transcriptase inhibitor (NNRTI).
Capsules: SUSTIVA is available as capsules for oral administration containing either 50 mg... | custom-source | 2025-02-12T13:51:20.021264 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr018,21360slr003_sustiva_lbl.pdf', 'application_number': 20972, 'submission_type': 'SUPPL ', 'submission_number': 18} |
14,035 | NDAs 20-972/S-019
21-360/S-004
Page 2
SUSTIVA®
(efavirenz) capsules and tablets
Rx only
DESCRIPTION
SUSTIVA® (efavirenz) is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside,
reverse transcriptase inhibitor (NNRTI).
Capsules: SUSTIVA is available as capsules for oral administration con... | custom-source | 2025-02-12T13:51:20.183607 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr019,21360slr004_sustiva_lbl.pdf', 'application_number': 20972, 'submission_type': 'SUPPL ', 'submission_number': 19} |
14,036 | NDA 20-972/S-021
NDA 21-360/S-005
Page 2
SUSTIVA®
(efavirenz) capsules and tablets
Rx only
DESCRIPTION
SUSTIVA® (efavirenz) is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside,
reverse transcriptase inhibitor (NNRTI).
Capsules: SUSTIVA is available as capsules for oral administration c... | custom-source | 2025-02-12T13:51:20.453253 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr021,21360slr005_sustiva_lbl.pdf', 'application_number': 20972, 'submission_type': 'SUPPL ', 'submission_number': 21} |
14,038 |
SUSTIVA®
1
(efavirenz) capsules and tablets
2
Rx only
3
DESCRIPTION
4
SUSTIVA® (efavirenz) is a human immunodeficiency virus type 1 (HIV-1) specific, non-
5
nucleoside, reverse transcriptase inhibitor (NNRTI).
6
Capsules: SUSTIVA is available as capsules for oral administration containing either
7
50 mg... | custom-source | 2025-02-12T13:51:20.910597 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s024,21360s009lbl.pdf', 'application_number': 20972, 'submission_type': 'SUPPL ', 'submission_number': 24} |
14,037 | NDA 20-972, S-022
NDA 21-360, S-006
Page 3
SUSTIVA®
(efavirenz) capsules and tablets
Rx only
DESCRIPTION
SUSTIVA® (efavirenz) is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside,
reverse transcriptase inhibitor (NNRTI).
Capsules: SUSTIVA is available as capsules for oral administratio... | custom-source | 2025-02-12T13:51:21.045342 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s022,21360s006lbl.pdf', 'application_number': 20972, 'submission_type': 'SUPPL ', 'submission_number': 22} |
14,039 | NDA 20-972/S-026
NDA 21-360/S-013
Page 3
SUSTIVA®
(efavirenz) capsules and tablets
Rx only
DESCRIPTION
SUSTIVA® (efavirenz) is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside,
reverse transcriptase inhibitor (NNRTI).
Capsules: SUSTIVA is available as capsules for oral administration c... | custom-source | 2025-02-12T13:51:21.171052 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020972s026,021360s013lbl.pdf', 'application_number': 20972, 'submission_type': 'SUPPL ', 'submission_number': 26} |
14,040 | NDA 21-360/S-014
Page 3
NDA 20-972/S-027
SUSTIVA®
(efavirenz) capsules and tablets
Rx only
DESCRIPTION
SUSTIVA® (efavirenz) is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside,
reverse transcriptase inhibitor (NNRTI).
Capsules: SUSTIVA is available as capsules for oral administration ... | custom-source | 2025-02-12T13:51:21.981566 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020972s027lbl.pdf', 'application_number': 20972, 'submission_type': 'SUPPL ', 'submission_number': 27} |
14,041 |
... | custom-source | 2025-02-12T13:51:22.432051 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021360s018,020972s031lbl.pdf', 'application_number': 20972, 'submission_type': 'SUPPL ', 'submission_number': 31} |
14,042 |
... | custom-source | 2025-02-12T13:51:22.518892 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020972s035,021360s023lbl.pdf', 'application_number': 20972, 'submission_type': 'SUPPL ', 'submission_number': 35} |
14,043 |
... | custom-source | 2025-02-12T13:51:22.583661 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020972s038lbl.pdf', 'application_number': 20972, 'submission_type': 'SUPPL ', 'submission_number': 38} |
14,045 | 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 | 2025-02-12T13:51:23.047964 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20973s8lbl.pdf', 'application_number': 20973, 'submission_type': 'SUPPL ', 'submission_number': 8} |
14,047 |
HIG... | custom-source | 2025-02-12T13:51:23.368178 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020973s022lbl.pdf', 'application_number': 20973, 'submission_type': 'SUPPL ', 'submission_number': 22} |
14,044 |
... | custom-source | 2025-02-12T13:51:23.422625 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s041,021360s029lbl.pdf', 'application_number': 20972, 'submission_type': 'SUPPL ', 'submission_number': 41} |
14,046 | NDA 20-973/S-009
Page 4
ACIPHEX®
\|a-se-|feks\
(rabeprazole sodium)
Delayed-Release Tablets
DESCRIPTION
The active ingredient in ACIPHEX® Delayed-Release Tablets is rabeprazole sodium, a substituted benzimidazole that inhibits
gastric acid secretion. Rabeprazole sodium is known chemically as 2-[[[4-(3... | custom-source | 2025-02-12T13:51:23.520524 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20973s009lbl.pdf', 'application_number': 20973, 'submission_type': 'SUPPL ', 'submission_number': 9} |
14,050 |
... | custom-source | 2025-02-12T13:51:24.186763 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020973s032lbl.pdf', 'application_number': 20973, 'submission_type': 'SUPPL ', 'submission_number': 32} |
14,048 |
... | custom-source | 2025-02-12T13:51:24.272421 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020973s025lbl.pdf', 'application_number': 20973, 'submission_type': 'SUPPL ', 'submission_number': 25} |
14,052 | custom-source | 2025-02-12T13:51:24.597837 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Prntlbl.pdf', 'application_number': 20975, 'submission_type': 'SUPPL ', 'submission_number': 3} | |
14,049 |
... | custom-source | 2025-02-12T13:51:24.680344 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020973s028lbl.pdf', 'application_number': 20973, 'submission_type': 'SUPPL ', 'submission_number': 28} |
14,051 |
... | custom-source | 2025-02-12T13:51:24.741303 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf', 'application_number': 20973, 'submission_type': 'SUPPL ', 'submission_number': 35} |
14,053 |
NDA 20-975/S-010
Page 3
September 2007
OptiMARK®
(gadoversetamide injection)
For Intravenous Injection Only
Mallinckrodt Inc.
PRESCRIBING INFORMATION
Rx only
PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION
WARNING... | custom-source | 2025-02-12T13:51:24.982920 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020975s010lbl.pdf', 'application_number': 20975, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,056 |
OptiMARK™ Pharmacy Bulk Package
OptiMARK™ 0.5 mmol/mL
(Gadoversetamide Injection)
PRESCRIBING INFORMATION
Rx only
Mallinckrodt Inc.
August 2013... | custom-source | 2025-02-12T13:51:25.329315 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020975s2302976s24lbl.pdf', 'application_number': 20975, 'submission_type': 'SUPPL ', 'submission_number': 23} |
14,054 | May 2007
OptiMARK~
(gadoversetamide injection)
For Intravenous Injection Only
Mallinckrodt Inc.
PRESCRIBING INFORMATION
Rx only
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in
patients with:
. acute or chronic severe renal insufficienc... | custom-source | 2025-02-12T13:51:25.480907 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020937s011,020976s011,020975s012lbl.pdf', 'application_number': 20975, 'submission_type': 'SUPPL ', 'submission_number': 12} |
14,055 |
OptiMARK™ 0.5 mmol/mL
(Gadoversetamide Injection)
PRESCRIBING INFORMATION
Rx only
Mallinckrodt Inc.
September 2010
OptiMARK™
(gadoversetamide injection)
For Intravenous Injection Only
Mallinckrodt Inc.
WARNING: NE... | custom-source | 2025-02-12T13:51:25.569082 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020975s017lbl.pdf', 'application_number': 20975, 'submission_type': 'SUPPL ', 'submission_number': 17} |
14,057 |
... | custom-source | 2025-02-12T13:51:25.735474 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s02420975s2520976s26lbl.pdf', 'application_number': 20975, 'submission_type': 'SUPPL ', 'submission_number': 25} |
14,058 | custom-source | 2025-02-12T13:51:25.752493 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark_prntlbl.pdf', 'application_number': 20976, 'submission_type': 'ORIG ', 'submission_number': 1} | |
14,060 | May 2007
OptiMARK~
(gadoversetamide injection)
For Intravenous Injection Only
Mallinckrodt Inc.
PRESCRIBING INFORMATION
Rx only
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in
patients with:
. acute or chronic severe renal insufficienc... | custom-source | 2025-02-12T13:51:25.978497 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020937s011,020976s011,020975s012lbl.pdf', 'application_number': 20976, 'submission_type': 'SUPPL ', 'submission_number': 11} |
14,059 | NDA 20-937/20-975/20-976/S-009
Page 3
OptiMARK® 0.5mmol/ml
(Gadoversetamide Injection)
PRESCRIBING INFORMATION
Mallinckrodt Inc.
January 2003
DESCRIPTION
OptiMARK® (gadoversetamide injection) is a formulation of a nonionic gadolinium chelate of
dieth... | custom-source | 2025-02-12T13:51:26.091381 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020937,020975,020976s009lbl.pdf', 'application_number': 20976, 'submission_type': 'SUPPL ', 'submission_number': 9} |
14,062 |
... | custom-source | 2025-02-12T13:51:26.251906 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s02420975s2520976s26lbl.pdf', 'application_number': 20976, 'submission_type': 'SUPPL ', 'submission_number': 26} |
14,061 |
OptiMARK™ 0.5 mmol/mL
(Gadoversetamide Injection)
PRESCRIBING INFORMATION
Rx only
Mallinckrodt Inc.
September 2010
OptiMARK™
(gadoversetamide injection)
For Intravenous Injection Only
Mallinckrodt Inc.
WARNING: NE... | custom-source | 2025-02-12T13:51:26.405165 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020976s016lbl.pdf', 'application_number': 20976, 'submission_type': 'SUPPL ', 'submission_number': 16} |
14,064 | ZIAGEN® (abacavir sulfate) Tablets
ZIAGEN® (abacavir sulfate) Oral Solution
3
PRESCRIBING INFORMATION
ZIAGEN®
(abacavir sulfate)
Tablets
ZIAGEN®
(abacavir sulfate)
Oral Solution
WARNING
FATAL HYPERSENSITIVITY REACTIONS HAVE BEEN ASSOCIATED WITH
THERAPY WITH ZIAGEN. PATIENTS DEVELOPING SIGNS OR SY... | custom-source | 2025-02-12T13:51:26.550541 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s8lbl.pdf', 'application_number': 20977, 'submission_type': 'SUPPL ', 'submission_number': 8} |
14,065 |
ZIAGEN®
(abacavir sulfate) Tablets
ZIAGEN®
(abacavir sulfate) Oral Solution
WARNING
FATAL HYPERSENSITIVITY REACTIONS HAVE BEEN ASSOCIATED WITH
THERAPY WITH ZIAGEN. PATIENTS DEVELOPING SIGNS OR SYMPTOMS OF
HYPERSENSITIVITY
(WHICH
INCLUDE
FEVER;
SKIN
RASH;
FATIGUE;
GASTROINTESTINAL SYMPTOMS SUCH AS NAU... | custom-source | 2025-02-12T13:51:26.742805 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20978slr012,20977slr010_ziagen_lbl.pdf', 'application_number': 20977, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,063 |
PRESCRIBING INFORMATION
ZIAGEN®
(abacavir sulfate)
Tablets
ZIAGEN®
(abacavir sulfate)
Oral Solution
WARNING
FATAL HYPERSENSITIVITY REACTIONS HAVE BEEN ASSOCIATED WITH
THERAPY WITH ZIAGEN. PATIENTS DEVELOPING SIGNS OR SYMPTOMS OF
HYPERSENSITIVITY (WHICH INCLUDE FEVER; SKIN RASH; FATIGUE;
GASTROINTEST... | custom-source | 2025-02-12T13:51:26.858507 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s7,20978s8lbl.pdf', 'application_number': 20977, 'submission_type': 'SUPPL ', 'submission_number': 7} |
14,067 | NDA 20-977/S-014
NDA 20-978/S-016
Page 3
PRESCRIBING INFORMATION
ZIAGEN®
(abacavir sulfate)
Tablets
ZIAGEN®
(abacavir sulfate)
Oral Solution
WARNINGS
Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity reactions have
been associated with ZIAGEN (abacavir sulfate). Hypersensitivity ... | custom-source | 2025-02-12T13:51:26.970705 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020977s014,020978s016lbl.pdf', 'application_number': 20977, 'submission_type': 'SUPPL ', 'submission_number': 14} |
14,066 | NDA 20-977/S-012
NDA 20-978/S-014
Page 5
PRESCRIBING INFORMATION
ZIAGEN®
(abacavir sulfate)
Tablets
ZIAGEN®
(abacavir sulfate)
Oral Solution
WARNINGS
Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity reactions have
been associated with ZIAGEN (abacavir sulfate). Hypersensitivity ... | custom-source | 2025-02-12T13:51:27.048910 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s012,20978s014lbl.pdf', 'application_number': 20977, 'submission_type': 'SUPPL ', 'submission_number': 12} |
14,068 |
HIGHLIGHTS OF PRESCRIBING ... | custom-source | 2025-02-12T13:51:27.323543 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s017,020978s020lbl.pdf', 'application_number': 20977, 'submission_type': 'SUPPL ', 'submission_number': 17} |
14,070 |
HIGHLIGHTS OF PRESCRIBING INFO... | custom-source | 2025-02-12T13:51:27.751426 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020977s023,020978s027lbl.pdf', 'application_number': 20977, 'submission_type': 'SUPPL ', 'submission_number': 23} |
14,069 |
HIGHLIGHTS OF PRESCR... | custom-source | 2025-02-12T13:51:27.875826 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s019,020978s022lbl.pdf', 'application_number': 20977, 'submission_type': 'SUPPL ', 'submission_number': 19} |
14,071 |
PRESCRIBING INFORMATION
ZIAGEN®
(abacavir sulfate)
Tablets
ZIAGEN®
(abacavir sulfate)
Oral Solution
WARNING
FATAL HYPERSENSITIVITY REACTIONS HAVE BEEN ASSOCIATED WITH
THERAPY WITH ZIAGEN. PATIENTS DEVELOPING SIGNS OR SYMPTOMS OF
HYPERSENSITIVITY (WHICH INCLUDE FEVER; SKIN RASH; FATIGUE;
GASTROINTEST... | custom-source | 2025-02-12T13:51:27.917209 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s7,20978s8lbl.pdf', 'application_number': 20978, 'submission_type': 'SUPPL ', 'submission_number': 8} |
14,072 | ZIAGEN® (abacavir sulfate) Tablets
ZIAGEN® (abacavir sulfate) Oral Solution
3
PRESCRIBING INFORMATION
ZIAGEN®
(abacavir sulfate)
Tablets
ZIAGEN®
(abacavir sulfate)
Oral Solution
WARNING
FATAL HYPERSENSITIVITY REACTIONS HAVE BEEN ASSOCIATED WITH
THERAPY WITH ZIAGEN. PATIENTS DEVELOPING SIGNS OR SY... | custom-source | 2025-02-12T13:51:28.043856 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s8lbl.pdf', 'application_number': 20978, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,073 |
ZIAGEN®
(abacavir sulfate) Tablets
ZIAGEN®
(abacavir sulfate) Oral Solution
WARNING
FATAL HYPERSENSITIVITY REACTIONS HAVE BEEN ASSOCIATED WITH
THERAPY WITH ZIAGEN. PATIENTS DEVELOPING SIGNS OR SYMPTOMS OF
HYPERSENSITIVITY
(WHICH
INCLUDE
FEVER;
SKIN
RASH;
FATIGUE;
GASTROINTESTINAL SYMPTOMS SUCH AS NAU... | custom-source | 2025-02-12T13:51:28.145794 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20978slr012,20977slr010_ziagen_lbl.pdf', 'application_number': 20978, 'submission_type': 'SUPPL ', 'submission_number': 12} |
14,074 | NDA 20-977/S-012
NDA 20-978/S-014
Page 5
PRESCRIBING INFORMATION
ZIAGEN®
(abacavir sulfate)
Tablets
ZIAGEN®
(abacavir sulfate)
Oral Solution
WARNINGS
Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity reactions have
been associated with ZIAGEN (abacavir sulfate). Hypersensitivity ... | custom-source | 2025-02-12T13:51:28.259729 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s012,20978s014lbl.pdf', 'application_number': 20978, 'submission_type': 'SUPPL ', 'submission_number': 14} |
14,075 | 3
PRESCRIBING INFORMATION
ZIAGEN®
(abacavir sulfate)
Tablets
ZIAGEN®
(abacavir sulfate)
Oral Solution
WARNINGS
Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity reactions have
been associated with ZIAGEN (abacavir sulfate). Hypersensitivity to abacavir is a
multi-organ clinical synd... | custom-source | 2025-02-12T13:51:28.471246 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s013,20978s015lbl.pdf', 'application_number': 20978, 'submission_type': 'SUPPL ', 'submission_number': 15} |
14,077 |
HIGHLIGHTS OF PRESCRIB... | custom-source | 2025-02-12T13:51:28.646659 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s024,020978s028lbl.pdf', 'application_number': 20978, 'submission_type': 'SUPPL ', 'submission_number': 28} |
14,076 | 3
PRESCRIBING INFORMATION
ZIAGEN®
(abacavir sulfate)
Tablets
ZIAGEN®
(abacavir sulfate)
Oral Solution
WARNINGS
Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity reactions have
been associated with ZIAGEN (abacavir sulfate). Hypersensitivity to abacavir is a
multi-organ clinical synd... | custom-source | 2025-02-12T13:51:28.814301 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020977s016,020978s019lbl.pdf', 'application_number': 20978, 'submission_type': 'SUPPL ', 'submission_number': 19} |
14,079 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
HYCAMTIN capsules safely and effectively. See full prescribing
information for HYCAMTIN capsules.
HYCAMTIN
® (topotecan) Capsules
Initial U.S. Approval: 1996
WARNING: BONE MARROW SUPPRESSION
See full pr... | custom-source | 2025-02-12T13:51:28.894092 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020981lbl.pdf', 'application_number': 20981, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,078 | 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 | 2025-02-12T13:51:29.016264 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020980s005lbl.pdf', 'application_number': 20980, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,080 |
HIGHLIGHTS OF... | custom-source | 2025-02-12T13:51:29.217768 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020981s002lbl.pdf', 'application_number': 20981, 'submission_type': 'SUPPL ', 'submission_number': 2} |
14,081 |
HIGHLIGHTS OF PRESCR... | custom-source | 2025-02-12T13:51:29.479133 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020981s005lbl.pdf', 'application_number': 20981, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,082 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to
use VENTOLIN HFA Inhalation Aerosol safely and effectively.
See full prescribing information for VENTOLIN HFA
Inhalation Aerosol.
VENTOLIN HFA
®
(albuterol sulfate) Inhalation Aerosol
Initial U.S. Approval: 1981... | custom-source | 2025-02-12T13:51:29.519285 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020983s016lbl.pdf', 'application_number': 20983, 'submission_type': 'SUPPL ', 'submission_number': 16} |
14,083 |
... | custom-source | 2025-02-12T13:51:29.676756 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020983s032lbl.pdf', 'application_number': 20983, 'submission_type': 'SUPPL ', 'submission_number': 32} |
14,084 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:51:29.733417 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20984lbl.pdf', 'application_number': 20984, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,086 | NDA 20-985/S-004
Page 3
Carac Cream, 0.5%
(fluorouracil cream)
FOR TOPICAL DERMATOLOGICAL USE ONLY
(NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE)
DESCRIPTION
Carac (fluorouracil cream) Cream, 0.5%, contains fluorouracil for topical dermatologic use.
Chemically, fluorouracil is 5-fluoro-2,4(1H,... | custom-source | 2025-02-12T13:51:29.910053 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20985slr004_carac_lbl.pdf', 'application_number': 20985, 'submission_type': 'SUPPL ', 'submission_number': 4} |
14,085 |
RAPLON
™
(rapacuronium bromide) for Injection Organon
Organon Inc.
West Orange, NJ 07052
5310167 8/99 14
Reference ID: 2867722
Revision 1
1
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
st
ruc
tu
ra
l
fo
r... | custom-source | 2025-02-12T13:51:30.043285 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020984s003lbl.pdf', 'application_number': 20984, 'submission_type': 'SUPPL ', 'submission_number': 3} |
14,091 |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993
NDA 19-938/S-064
APPROVAL LETTER
NDA 19-959/S-067
NDA 19-991/S-068
NDA 20-986/S-055
NovoNordisk Inc
Attention: Mary Ann ... | custom-source | 2025-02-12T13:51:30.064740 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s064,019959s067,019991s068,020986s055ltr.pdf', 'application_number': 20986, 'submission_type': 'SUPPL ', 'submission_number': 55} |
14,087 | Page 1
NDA 20-986
Submitted to FDA June 7, 2000
NovoLogTM
Insulin Aspart (rDNA origin) Injection
DESCRIPTION
NovoLogTM (insulin aspart [rDNA origin] injection) is a human insulin analogue that is a rapid-acting,
parenteral blood glucose-lowering agent. NovoLogTM is homologous with regular human insulin with
the excepti... | custom-source | 2025-02-12T13:51:30.117153 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20986lbl.pdf', 'application_number': 20986, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,096 | PROTONIX
(pantoprazole sodium)
Delayed-Release Tablets
DESCRIPTION
The active ingredient in PROTONIX (pantoprazole sodium) Delayed-Release Tablets is a substituted
benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole
sesquihydrate, a compound that inhibits gas... | custom-source | 2025-02-12T13:51:30.172872 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20987lbl.pdf', 'application_number': 20987, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,097 | NDA 20-987/S-023
Page 3
PROTONIX
(pantoprazole sodium)
Delayed-Release Tablets
only
DESCRIPTION
The active ingredient in PROTONIX (pantoprazole sodium) Delayed-Release Tablets is a substituted
benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-
benzimidazole sesq... | custom-source | 2025-02-12T13:51:30.403948 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr023_protonix_lbl.pdf', 'application_number': 20987, 'submission_type': 'SUPPL ', 'submission_number': 17} |
14,098 | NDA 20-987/S-022
Page 3
PROTONIX
(pantoprazole sodium)
Delayed-Release Tablets
only
DESCRIPTION
The active ingredient in PROTONIX (pantoprazole sodium) Delayed-Release Tablets is a substituted
benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-
benzimidazole sesq... | custom-source | 2025-02-12T13:51:30.503119 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr022_protonix_lbl.pdf', 'application_number': 20987, 'submission_type': 'SUPPL ', 'submission_number': 22} |
14,100 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
PROTONIX safely and effectively. See full prescribing information for
PROTONIX.
PROTONIX (pantoprazole sodium) delayed-release tablets
PROTONIX (pantoprazole sodium) for ... | custom-source | 2025-02-12T13:51:30.614843 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020987s038,022020s003lbl.pdf', 'application_number': 20987, 'submission_type': 'SUPPL ', 'submission_number': 38} |
14,099 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
PROTONIX safely and ef... | custom-source | 2025-02-12T13:51:30.822846 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022020s002,020987s036s037lbl.pdf', 'application_number': 20987, 'submission_type': 'SUPPL ', 'submission_number': 37} |
14,101 |
HIGHLIGHTS OF PRESCRIBING INFORM... | custom-source | 2025-02-12T13:51:30.948361 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022020s004,020987s039lbl.pdf', 'application_number': 20987, 'submission_type': 'SUPPL ', 'submission_number': 39} |
14,103 |
... | custom-source | 2025-02-12T13:51:31.133388 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022020s011-020987s049lbl.pdf', 'application_number': 20987, 'submission_type': 'SUPPL ', 'submission_number': 49} |
14,102 |
... | custom-source | 2025-02-12T13:51:31.316875 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s043,022020s006lbl.pdf', 'application_number': 20987, 'submission_type': 'SUPPL ', 'submission_number': 43} |
14,105 | NDA 20-988/S-025
Page 3
PROTONIX I.V.
(pantoprazole sodium)
for Injection
only
DESCRIPTION
The active ingredient in PROTONIX I.V. (pantoprazole sodium) for Injection is a substituted
benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-
benzimidazole, a compound ... | custom-source | 2025-02-12T13:51:31.449121 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr025_protonix_lbl.pdf', 'application_number': 20988, 'submission_type': 'SUPPL ', 'submission_number': 25} |
14,107 | NDA 20-988/S-032
Page 3
PROTONIX® I.V.
(pantoprazole sodium)
for Injection
] only
DESCRIPTION
The active ingredient in PROTONIX® I.V. (pantoprazole sodium) for Injection is a substituted
benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-
benzimidazole, a compound th... | custom-source | 2025-02-12T13:51:31.628350 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020988s032lbl.pdf', 'application_number': 20988, 'submission_type': 'SUPPL ', 'submission_number': 32} |
14,104 | NDA 20-988/S-019
Page 3
PROTONIX I.V.
(pantoprazole sodium)
for Injection
only
DESCRIPTION
The active ingredient in PROTONIX I.V. (pantoprazole sodium) for Injection is a substituted
benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-
benzimidazole, a compound ... | custom-source | 2025-02-12T13:51:31.687341 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr019_protonix_lbl.pdf', 'application_number': 20988, 'submission_type': 'SUPPL ', 'submission_number': 19} |
14,106 |
NDA 020988
NDA 020988/S-027
NDA 020988/S-070
SUPPLEMENT APPROVAL
FULFILLMENT OF POSTMARKETING REQUIREMENTS
Wyeth Pharmaceuticals LLC
Attention: Nestor Duci
Senior Manager, Pfizer Global Regulatory Sciences
66 Hudson Boulevard East
New York, NY 10001
Dear Nestor Duci:
Please refer to your supplemen... | custom-source | 2025-02-12T13:51:31.965321 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020988Orig1s027s070lbl.pdf', 'application_number': 20988, 'submission_type': 'SUPPL ', 'submission_number': 27} |
14,108 |
_______________________________________________________________________________________________________________________________________
_____... | custom-source | 2025-02-12T13:51:31.985738 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s041lbl.pdf', 'application_number': 20988, 'submission_type': 'SUPPL ', 'submission_number': 41} |
14,110 | NDA 20-989 S006
Page 3
EVOXAC® Capsules
(cevimeline hydrochloride)
DESCRIPTION
Cevimeline is cis-2'-methylspiro {1-azabicyclo [2.2.2] octane-3, 5' –[1,3] oxathiolane} hydrochloride,
hydrate (2:1). Its empirical formula is C10H17NOS.HCI.1/2H20, and its structural formula is:
CEVIMELINE HAS A MOLECULAR WE... | custom-source | 2025-02-12T13:51:32.097388 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020989s006lbl.pdf', 'application_number': 20989, 'submission_type': 'SUPPL ', 'submission_number': 6} |
14,109 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:51:32.183026 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020988s045lbl.pdf', 'application_number': 20988, 'submission_type': 'SUPPL ', 'submission_number': 45} |
14,112 | 1
[FDA Approved Labeling for Zoloft® for the Treatment of Social Anxiety Disorder
Attachment to FDA Approval Letter for NDA 19-839/S-045]
69-4721-00-4.2
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
DESCRIPTION
ZOLOFT® (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) for o... | custom-source | 2025-02-12T13:51:32.543630 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020990s011lbl.pdf', 'application_number': 20990, 'submission_type': 'SUPPL ', 'submission_number': 11} |
14,111 | 1
ATTACHMENT
NDA 20-990 ZOLOFT ORAL CONCENTRATE
FINAL LABELING
Note: Below is the final labeling for Zoloft Oral Concentrate. We note your agreement to this
labeling in a telephone conversation dated November 30, 1999, between Mr. Paul David, of
this Agency, and Dr. Martha Brumfield of Pfiizer. In addition to the labe... | custom-source | 2025-02-12T13:51:32.546971 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20990lbl.pdf', 'application_number': 20990, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,114 |
1
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
Suicidality in Children and Adolescents
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term
studies in children and adolescents with Major Depressive Disorder (MDD) and other
psychiatric di... | custom-source | 2025-02-12T13:51:32.859960 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf', 'application_number': 20990, 'submission_type': 'SUPPL ', 'submission_number': 19} |
14,116 |
1
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
Suicidality in Children and Adolescents
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term
studies in children and adolescents with Major Depressive Disorder (MDD) and other
psychiatric di... | custom-source | 2025-02-12T13:51:33.129058 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf', 'application_number': 20990, 'submission_type': 'SUPPL ', 'submission_number': 26} |
14,113 |
1
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
DESCRIPTION
ZOLOFT® (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) for oral
administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following
chemical name: (1S-cis)-4-(3... | custom-source | 2025-02-12T13:51:33.453805 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf', 'application_number': 20990, 'submission_type': 'SUPPL ', 'submission_number': 13} |
14,115 |
1
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
Suicidality in Children and Adolescents
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term
studies in children and adolescents with Major Depressive Disorder (MDD) and other
psychiatric di... | custom-source | 2025-02-12T13:51:33.460790 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf', 'application_number': 20990, 'submission_type': 'SUPPL ', 'submission_number': 20} |
14,117 |
SERTRALINE HYDROCHLORIDE
Tablets and Oral Concentrate
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) and ot... | custom-source | 2025-02-12T13:51:33.783143 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027lbl.pdf', 'application_number': 20990, 'submission_type': 'SUPPL ', 'submission_number': 27} |
14,118 |
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
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
depr... | custom-source | 2025-02-12T13:51:33.865139 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019839s070,020990s032lbl.pdf', 'application_number': 20990, 'submission_type': 'SUPPL ', 'submission_number': 32} |
14,119 |
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
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
depr... | custom-source | 2025-02-12T13:51:34.238596 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf', 'application_number': 20990, 'submission_type': 'SUPPL ', 'submission_number': 34} |
14,120 |
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
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 (... | custom-source | 2025-02-12T13:51:34.257268 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf', 'application_number': 20990, 'submission_type': 'SUPPL ', 'submission_number': 37} |
14,122 |
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
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
depr... | custom-source | 2025-02-12T13:51:34.442953 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf', 'application_number': 20990, 'submission_type': 'SUPPL ', 'submission_number': 40} |
14,121 |
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
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
depr... | custom-source | 2025-02-12T13:51:34.635821 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019839s079,020990s038lbl.pdf', 'application_number': 20990, 'submission_type': 'SUPPL ', 'submission_number': 38} |
14,123 | NDA 20-992 Cenestin™ (synthetic conjugated estrogens, A) Tablets
Physicians Package Insert
Page: 1
Date printed: Mar 23, 1999
Cenestin™
(synthetic conjugated estrogens, A) Tablets
] only
PRESCRIBING INFORMATION
DESCRIPTION
Synthetic conjugated estrogens, A tablets contain a blend of nine (9) synthetic estrogenic substa... | custom-source | 2025-02-12T13:51:34.859913 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20992lbl.pdf', 'application_number': 20992, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,124 | NDA 20-992 Cenestin™ (synthetic conjugated estrogens, A) Tablets
Proposed Physicians Package Insert
Page: 4
Date printed: Jun 21, 2002
Cenestin®
(synthetic conjugated estrogens, A) Tablets
Rx only
DESCRIPTION
Synthetic conjugated estrogens, A tablets contain a blend of nine (9) synthetic estrogeni... | custom-source | 2025-02-12T13:51:34.910034 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20992s16lbl.pdf', 'application_number': 20992, 'submission_type': 'SUPPL ', 'submission_number': 16} |
14,125 |
_________________
_________________
__________________
_________________
_____________... | custom-source | 2025-02-12T13:51:35.075873 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020992s034lbl.pdf', 'application_number': 20992, 'submission_type': 'SUPPL ', 'submission_number': 34} |
14,127 | 01/05/99 4:16 PM draft label
1
CELEBREX™
1
(celecoxib capsules)
2
3
4
DESCRIPTION
5
6
CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)-3-
7
(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl substituted
8
pyrazole. It has the following ch... | custom-source | 2025-02-12T13:51:35.219796 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20998lbl.pdf', 'application_number': 20998, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,126 | 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 | 2025-02-12T13:51:35.254208 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20997lbl.pdf', 'application_number': 20997, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,128 | 1
CELEBREX™
(celecoxib capsules)
DESCRIPTION
CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)-3-
(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl substituted pyrazole.
It has the following chemical structure:
CH3
N
N
CF3
S
NH2
O
O
The empirical formula for celecoxib is C17H14F... | custom-source | 2025-02-12T13:51:35.674371 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21156lbl.pdf', 'application_number': 20998, 'submission_type': 'SUPPL ', 'submission_number': 7} |
14,129 | NDA 20-998/S-009
Page 3
CELEBREX
(celecoxib capsules)
DESCRIPTION
CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-
1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. It has the following
chemical structure:
CH3
N
N
CF3
S
NH... | custom-source | 2025-02-12T13:51:35.825923 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20998s009lbl.pdf', 'application_number': 20998, 'submission_type': 'SUPPL ', 'submission_number': 9} |
14,130 | Document Information Page
This page is for FDA internal use only. Do NOT send this page with the letter.
Application #(s):
NDA 20-998/S-010
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 | 2025-02-12T13:51:35.843622 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20998s10lbl.pdf', 'application_number': 20998, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,131 | NDA 20-998/S-016
Page 3
CELEBREX
celecoxib capsules
DESCRIPTION
CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-
pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. It has the following chemical
structure:
CH3
N
N
CF3
S
NH2
O
O
Th... | custom-source | 2025-02-12T13:51:35.957921 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20998slr016_celebrex_lbl.pdf', 'application_number': 20998, 'submission_type': 'SUPPL ', 'submission_number': 16} |
14,132 | NDA 20-998/S-018
NDA 20-998/S-019
Page 3
CELEBREX®
celecoxib capsules
Cardiovascular Risk
• CELEBREX may cause an increased risk of serious cardiovascular thrombotic events, myocardial
infarction, and stroke, which can be fatal. All NSAIDs may have a similar risk. This risk may
increase with duration of us... | custom-source | 2025-02-12T13:51:36.329315 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020998s018,019lbl.pdf', 'application_number': 20998, 'submission_type': 'SUPPL ', 'submission_number': 19} |
14,134 |
1
CELEBREX®
celecoxib capsules
Cardiovascular Risk
• CELEBREX may cause an increased risk of serious cardiovascular thrombotic
events, myocardial infarction, and stroke, which can be fatal. All NSAIDs may
have a similar risk. This risk may increase with duration of use. Patients with
cardiov... | custom-source | 2025-02-12T13:51:36.509223 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020998s026lbl.pdf', 'application_number': 20998, 'submission_type': 'SUPPL ', 'submission_number': 26} |
14,133 |
1
1
2
3
4
5
CELEBREX®
6
celecoxib capsules
7
8
Cardiovascular Risk
9
• CELEBREX may cause an increased risk of serious cardiovascular thrombotic
10
events, myocardial infarction, and stroke, which can be fatal. All NSAIDs may
11
have a similar risk. This risk may increase with dur... | custom-source | 2025-02-12T13:51:36.592978 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020998s021lbl.pdf', 'application_number': 20998, 'submission_type': 'SUPPL ', 'submission_number': 21} |
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