id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
14,445 |
Page 1 of 5
Optivar (azelastine hydrochloride) Solution/ Drops
[Meda Pharmaceuticals Inc.]
OPTIVAR®
azelastine hydrochloride
ophthalmic solution, 0.05%
DESCRIPTION:
OPTIVAR® (azelastine hydrochloride ophthalmic solution), 0.05% is a sterile ophthalmic
solution containing azelastine hyd... | custom-source | 2025-02-12T13:52:33.305134 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021127s013lbl.pdf', 'application_number': 21127, 'submission_type': 'SUPPL ', 'submission_number': 13} |
14,447 |
Neurontin® (gabapentin) Capsules
Neurontin® (gabapentin) Tablets
Neurontin®(gabapentin) Oral Solution
DESCRIPTION
Neurontin® (gabapentin) Capsules, Neurontin (gabapentin) Tablets, and Neurontin (gabapentin)
Oral Solution are supplied as imprinted hard shell capsules containing 100 mg,
... | custom-source | 2025-02-12T13:52:33.428931 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020235s041,020882s028,021129s027lbl.pdf', 'application_number': 21129, 'submission_type': 'SUPPL ', 'submission_number': 27} |
14,448 |
Neurontin® (gabapentin) Capsules
Neurontin® (gabapentin) Tablets
Neurontin® (gabapentin) Oral Solution
DESCRIPTION
Neurontin® (gabapentin) Capsules, Neurontin (gabapentin) Tablets, and Neurontin (gabapentin)
Oral Solution are supplied as imprinted hard shell capsules containing 100 mg,
3... | custom-source | 2025-02-12T13:52:33.513138 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021129s029lbl.pdf', 'application_number': 21129, 'submission_type': 'SUPPL ', 'submission_number': 29} |
14,449 |
NDA 020235/S-054, S-055, S-056
NDA 020882/S-038, S-039, S-040
NDA 021129/S-035, S-036, S-037
FDA Approved Labeling Text dated 05/01/2013
Page 1 of 37
Neurontin® (gabapentin) Capsules
Neurontin® (gabapentin) Tablets
Neurontin® (gabapentin) Oral S... | custom-source | 2025-02-12T13:52:33.640440 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf', 'application_number': 21129, 'submission_type': 'SUPPL ', 'submission_number': 36} |
14,451 |
HIGHLIGHTS OF PR... | custom-source | 2025-02-12T13:52:33.820833 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s060,020882s043,021129s042lbl.pdf', 'application_number': 21129, 'submission_type': 'SUPPL ', 'submission_number': 42} |
14,452 | 1
__________________________________
ZYVOXTM
linezolid injection
linezolid tablets
linezolid for oral suspension
______________________________________________________
DESCRIPTION
ZYVOX I.V. Injection, ZYVOX Tablets, and ZYVOX for Oral Suspension contain linezolid, which is a synthetic
antibacterial agent of the oxazol... | custom-source | 2025-02-12T13:52:34.167166 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21130lbl.pdf', 'application_number': 21130, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,450 |
... | custom-source | 2025-02-12T13:52:34.170309 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020235s057,020882s041,021129s039lbl.pdf', 'application_number': 21129, 'submission_type': 'SUPPL ', 'submission_number': 39} |
14,453 |
DESCRIPTION
ZYVOX I.V. Injection, ZYVOX Tablets, and ZYVOX for Oral Suspension contain linezolid, which is
a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-
[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide.
The empirical for... | custom-source | 2025-02-12T13:52:34.413434 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21130slr002,21131slr002,21132slr002_zyvox_lbl.pdf', 'application_number': 21130, 'submission_type': 'SUPPL ', 'submission_number': 2} |
14,454 |
1
DESCRIPTION
ZYVOX I.V. Injection, ZYVOX Tablets, and ZYVOX for Oral Suspension contain
linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical
name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]
methyl]-acetamide.
The empirical ... | custom-source | 2025-02-12T13:52:34.823581 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21132se5-003,21131se5-003,21130se5-003_zyvox_lbl.pdf', 'application_number': 21130, 'submission_type': 'SUPPL ', 'submission_number': 3} |
14,456 |
1
ZYVOX ®
linezolid injection
linezolid tablets
linezolid for oral
suspension
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
ZYVOX formulations and other antibacterial drugs, ZYVOX should be used only to treat
or prevent infections that are proven or stron... | custom-source | 2025-02-12T13:52:35.460607 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf', 'application_number': 21130, 'submission_type': 'SUPPL ', 'submission_number': 8} |
14,455 | NDA 21-130/S-006
NDA 21-131/S-007
NDA 21-132/S-006
Page 4
ZYVOX
NDA 21-130, 21-131, 21-132
Proposed Package Insert for MDRSP indication
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYVOX
formulations and other antibacterial drugs, ZYVOX should be used only to t... | custom-source | 2025-02-12T13:52:35.551029 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21130se5-006,21131se5-007,21132se5-006_zyvox_lbl.pdf', 'application_number': 21130, 'submission_type': 'SUPPL ', 'submission_number': 6} |
14,457 | ZYVOXCI
(linezolid) injection
(Iinezolid) tablets
(Iinezolid) for oral
suspension
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
ZYVOX formulations and other antibacterial drgs, ZYVOX should be used only to treat or
prevent infections that are proven or strongly suspected to be c... | custom-source | 2025-02-12T13:52:35.960014 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021130s012,021131s012,021132s012lbl.pdf', 'application_number': 21130, 'submission_type': 'SUPPL ', 'submission_number': 12} |
14,459 |
DOCUMENT INFORMATION PAGE
DARRTS COMMUNICATION
This page is for FDA internal use only. Do NOT send this page with the letter.
Application #(s): NDA 21-130/S-020, NDA 21-131/S-017, NDA 21-132/S-018
CommunicationType:
Correspondence
Communication Group:
sNDA Action
Communication Name: Approval
Communicat... | custom-source | 2025-02-12T13:52:36.026081 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021130s020,021131s017,021132s018lbl.pdf', 'application_number': 21130, 'submission_type': 'SUPPL ', 'submission_number': 20} |
14,458 |
NDA 21-130/S-016/S-017
NDA 21-131/S-013/S-014
NDA 21-132/S-014/S-015
Page 5
ZYVOX ®
(linezolid) injection
(linezolid) tablets
(linezolid) for oral
suspension
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYVOX
fo... | custom-source | 2025-02-12T13:52:36.284615 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021130s016,021131s013,021132s014lbl.pdf', 'application_number': 21130, 'submission_type': 'SUPPL ', 'submission_number': 16} |
14,460 |
_______________________________________________________________________________________________________________________________________
---------------------DOSAGE FORMS AND STRENGTHS-... | custom-source | 2025-02-12T13:52:36.594098 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf', 'application_number': 21130, 'submission_type': 'SUPPL ', 'submission_number': 23} |
14,462 | 1
__________________________________
ZYVOXTM
linezolid injection
linezolid tablets
linezolid for oral suspension
______________________________________________________
DESCRIPTION
ZYVOX I.V. Injection, ZYVOX Tablets, and ZYVOX for Oral Suspension contain linezolid, which is a synthetic
antibacterial agent of the oxazol... | custom-source | 2025-02-12T13:52:36.691418 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21130lbl.pdf', 'application_number': 21131, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,461 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:52:37.606841 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021130s030,021131s029,021132s034lbl.pdf', 'application_number': 21130, 'submission_type': 'SUPPL ', 'submission_number': 35} |
14,463 | NDA 21-130/S-006
NDA 21-131/S-007
NDA 21-132/S-006
Page 4
ZYVOX
NDA 21-130, 21-131, 21-132
Proposed Package Insert for MDRSP indication
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYVOX
formulations and other antibacterial drugs, ZYVOX should be used only to t... | custom-source | 2025-02-12T13:52:37.642290 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21130se5-006,21131se5-007,21132se5-006_zyvox_lbl.pdf', 'application_number': 21131, 'submission_type': 'SUPPL ', 'submission_number': 7} |
14,464 |
1
ZYVOX ®
linezolid injection
linezolid tablets
linezolid for oral
suspension
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
ZYVOX formulations and other antibacterial drugs, ZYVOX should be used only to treat
or prevent infections that are proven or stron... | custom-source | 2025-02-12T13:52:37.782579 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf', 'application_number': 21131, 'submission_type': 'SUPPL ', 'submission_number': 9} |
14,465 |
_______________________________________________________________________________________________________________________________________
---------------------DOSAGE FORMS AND STRENGTHS-... | custom-source | 2025-02-12T13:52:37.820054 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf', 'application_number': 21131, 'submission_type': 'SUPPL ', 'submission_number': 21} |
14,467 | _______________________________________________________________________________________________________________________________________
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ZYVOX
safely and effectively. See full prescribing informati... | custom-source | 2025-02-12T13:52:38.504982 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021130s032,021131s026,021132s031lbl.pdf', 'application_number': 21131, 'submission_type': 'SUPPL ', 'submission_number': 26} |
14,466 |
_______________________________________________________________________________________________________________________________________
---------------------DOSAGE FORMS AND STRENGTHS-... | custom-source | 2025-02-12T13:52:38.885179 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf', 'application_number': 21131, 'submission_type': 'SUPPL ', 'submission_number': 22} |
14,469 |
1
DESCRIPTION
ZYVOX I.V. Injection, ZYVOX Tablets, and ZYVOX for Oral Suspension contain
linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical
name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]
methyl]-acetamide.
The empirical ... | custom-source | 2025-02-12T13:52:38.991499 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21132se5-003,21131se5-003,21130se5-003_zyvox_lbl.pdf', 'application_number': 21132, 'submission_type': 'SUPPL ', 'submission_number': 3} |
14,468 |
DESCRIPTION
ZYVOX I.V. Injection, ZYVOX Tablets, and ZYVOX for Oral Suspension contain linezolid, which is
a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-
[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide.
The empirical for... | custom-source | 2025-02-12T13:52:39.092528 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21130slr002,21131slr002,21132slr002_zyvox_lbl.pdf', 'application_number': 21132, 'submission_type': 'SUPPL ', 'submission_number': 2} |
14,470 | NDA 21-130/S-006
NDA 21-131/S-007
NDA 21-132/S-006
Page 4
ZYVOX
NDA 21-130, 21-131, 21-132
Proposed Package Insert for MDRSP indication
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYVOX
formulations and other antibacterial drugs, ZYVOX should be used only to t... | custom-source | 2025-02-12T13:52:39.660320 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21130se5-006,21131se5-007,21132se5-006_zyvox_lbl.pdf', 'application_number': 21132, 'submission_type': 'SUPPL ', 'submission_number': 6} |
14,473 |
s
t
ruct
ur
al f or mula
Nitrostat®
(Nitroglycerin Sublingual Tablets, USP)
DESCRIPTION
NITROSTAT is a stabilized sublingual compressed nitroglycerin tablet that contains
0.3 mg, 0.4 mg , or 0.6 mg nitroglycerin; as well as lactose monohydrate, NF; glyceryl
monostearate, NF; pregelatinized starch, NF; ca... | custom-source | 2025-02-12T13:52:39.831024 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021134s005lbl.pdf', 'application_number': 21134, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,471 |
_______________________________________________________________________________________________________________________________________
---------------------DOSAGE FORMS AND STRENGTHS-... | custom-source | 2025-02-12T13:52:39.860098 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf', 'application_number': 21132, 'submission_type': 'SUPPL ', 'submission_number': 23} |
14,472 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:52:39.877950 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021130s030,021131s029,021132s034lbl.pdf', 'application_number': 21132, 'submission_type': 'SUPPL ', 'submission_number': 34} |
14,474 |
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville, MD 20857
NDA 21-135/S-006
Luitpold Pharmaceuticals, Inc.
c/o Sonnenschein Nath & Rosenthal
Attention: Peter S. Reichertz, Esq.
1301 K Street N.W.
Suite 600, East Tower
Washington, D.C. 20005
... | custom-source | 2025-02-12T13:52:40.122972 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21135se2-005ltr.pdf', 'application_number': 21135, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,477 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:52:40.301648 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021135s020lbl.pdf', 'application_number': 21135, 'submission_type': 'SUPPL ', 'submission_number': 20} |
14,475 | NDA 21-135/S-008
Page 4
Venofer®
DESCRIPTION
Venofer® (iron sucrose injection, USP) is a brown, sterile, aqueous, complex of polynuclear iron (III)-
hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of
approximately 34,000 – 60,000 daltons and a proposed structural formula:... | custom-source | 2025-02-12T13:52:40.316747 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s008lbl.pdf', 'application_number': 21135, 'submission_type': 'SUPPL ', 'submission_number': 8} |
14,476 | NDA 21-135/S-015
Page 3
Venofer ®
(iron sucrose injection, USP)
Rx Only
DESCRIPTION
Venofer® (iron sucrose injection, USP) is a brown, sterile, aqueous, complex of polynuclear iron (III)-
hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of
approximately 34,000 – 60,0... | custom-source | 2025-02-12T13:52:40.453897 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s015lbl.pdf', 'application_number': 21135, 'submission_type': 'SUPPL ', 'submission_number': 15} |
14,478 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
VENOFER safely and effectively. See full prescribing information for
VENOFER.
Venofer ® (iron sucrose injection, USP)
Initial U.S. Approval: 2000
-----------------------------RECENT MAJOR CHANGES----... | custom-source | 2025-02-12T13:52:40.647735 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021135s023lbl.pdf', 'application_number': 21135, 'submission_type': 'SUPPL ', 'submission_number': 23} |
14,480 | NDA 21-136/S-001
Page 3
SecreFlo
Secretin for Injection
DESCRIPTION
SecreFlo (secretin) is a pure sterile, nonpyrogenic, lyophilized white cake powder acetate salt of secretin, a
peptide hormone. Secretin has an amino acid sequence identical to the naturally occurring porcine secretin
consisting of... | custom-source | 2025-02-12T13:52:40.691223 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21136s1lbl.pdf', 'application_number': 21136, 'submission_type': 'SUPPL ', 'submission_number': 1} |
14,481 | custom-source | 2025-02-12T13:52:40.745742 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-137_Levolet_Prntlbl.pdf', 'application_number': 21137, 'submission_type': 'ORIG ', 'submission_number': 1} | |
14,479 |
__________________________________________________________________________________
... | custom-source | 2025-02-12T13:52:40.759974 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021135s024lbl.pdf', 'application_number': 21135, 'submission_type': 'SUPPL ', 'submission_number': 24} |
14,482 | custom-source | 2025-02-12T13:52:40.999844 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-140_Imodium_prntlbl.pdf', 'application_number': 21140, 'submission_type': 'ORIG ', 'submission_number': 1} | |
14,484 | FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
100g
NDC 63032-031-00
CFC FREE
Description: Each gram contains
0.5 mg clobetasol propionate USP in
a hydroalcoholic, thermolabile foam.
The foam also contains cetyl alcohol,
citric acid, ethanol (60%),
polysorbate 60, potassium citrate,
propylene glycol, purified... | custom-source | 2025-02-12T13:52:41.219103 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21142slr009_olux_lbl.pdf', 'application_number': 21142, 'submission_type': 'SUPPL ', 'submission_number': 9} |
14,483 | OLUX Foam, 0.05%
(clobetasol propionate)
Rx Only
For Dermatologic Use Only
Not for Ophthalmic Use
DESCRIPTION
OLUX Foam contains clobetasol propionate, USP, a synthetic corticosteroid, for topical dermatologic
use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight
degree... | custom-source | 2025-02-12T13:52:41.263708 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21142se1-004_Olux_lbl.pdf', 'application_number': 21142, 'submission_type': 'SUPPL ', 'submission_number': 4} |
14,485 | 4.25"
.03"
Copy to die
tolerance
.06"
Bleed
.02"
CORNER
RADIUS
1.58"
Net wt.12 g
Recyclable
Aluminum
Container
CFC FREE
PROFESSIONAL SAMPLE—NOT FOR RESALE
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
Please see full prescribing information.
Warning: FLAMMABLE. AVOID FIRE,
FLAME, OR SMOKING DURING AND
IMMEDIATEL... | custom-source | 2025-02-12T13:52:41.385139 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21142scs010_olux_lbl.pdf', 'application_number': 21142, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,486 |
... | custom-source | 2025-02-12T13:52:41.584811 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021142s019lbl.pdf', 'application_number': 21142, 'submission_type': 'SUPPL ', 'submission_number': 19} |
14,487 | 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 | 2025-02-12T13:52:41.829214 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21143lbl.pdf', 'application_number': 21143, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,488 | NDA 21-144
Page 5
Rev. March 2004
KETEK
(telithromycin) Tablets
To reduce the development of drug-resistant bacteria and maintain the effectiveness of KETEK and
other antibacterial drugs, KETEK should be used only to treat infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION... | custom-source | 2025-02-12T13:52:41.917203 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21144_ketek_lbl.pdf', 'application_number': 21144, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,489 | NDA 21-144/S-011
Page 3
Rev. June 2006
KETEK®
(telithromycin) Tablets
To reduce the development of drug-resistant bacteria and maintain the effectiveness of KETEK and
other antibacterial drugs, KETEK should be used only to treat infections that are proven or strongly
suspected to be caused by bacteria.
... | custom-source | 2025-02-12T13:52:42.109835 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021144s011lbl.pdf', 'application_number': 21144, 'submission_type': 'SUPPL ', 'submission_number': 11} |
14,490 | NDA 21-144/S-012
Rev February 2007
KETEK®
(telithromycin) Tablets
Ketek is contraindicated in patients with myasthenia gravis. There have been reports of fatal and life-
threatening respiratory failure in patients with myasthenia gravis associated with the use of Ketek. (See
CONTRAINDICATIONS.)
... | custom-source | 2025-02-12T13:52:42.130425 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021144s012lbl.pdf', 'application_number': 21144, 'submission_type': 'SUPPL ', 'submission_number': 12} |
14,492 |
... | custom-source | 2025-02-12T13:52:42.354037 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021144s019lbl.pdf', 'application_number': 21144, 'submission_type': 'SUPPL ', 'submission_number': 19} |
14,491 |
Revised XXXXXX 2010
KETEK®
(telithromycin) Tablets
Ketek is contraindicated in patients with myasthenia gravis. There have been reports of fatal
and life-threatening respiratory failure in patients with myasthenia gravis associated with the use
of Ketek. (See CONTRAINDICATIONS.)
To red... | custom-source | 2025-02-12T13:52:42.466410 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021144s014lbl.pdf', 'application_number': 21144, 'submission_type': 'SUPPL ', 'submission_number': 14} |
14,494 | custom-source | 2025-02-12T13:52:42.478318 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-146_Atropine%20Sulfate_prntlbl.pdf', 'application_number': 21146, 'submission_type': 'ORIG ', 'submission_number': 1} | |
14,493 | 1
Bristol-Myers Squibb Labeling VANIQA - July 27, 2000
Rx only
VANIQA™
(eflornithine hydrochloride) Cream, 13.9%
For topical dermatological use only. Not for ophthalmic, oral or intravaginal use.
DESCRIPTION
VANIQATM is a cream containing 13.9% (139 mg/g) of anhydrous eflornithine hydrochloride as
eflornithine... | custom-source | 2025-02-12T13:52:42.528901 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21145lbl.pdf', 'application_number': 21145, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,495 |
___________________________________________... | custom-source | 2025-02-12T13:52:42.643495 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021146s015lbl.pdf', 'application_number': 21146, 'submission_type': 'SUPPL ', 'submission_number': 15} |
14,504 |
company logo
FOR SUBCUTANEOUS USE
DESCRIPTION
Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) is a sterile liquid
preparation of choriogonadotropin alfa (recombinant human Chorionic
Gonadotropin, r-hCG). Choriogonadotropin alfa is a water soluble glycoprotein
consisting of two n... | custom-source | 2025-02-12T13:52:42.847399 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021149s020lbl.pdf', 'application_number': 21149, 'submission_type': 'SUPPL ', 'submission_number': 20} |
14,502 | Ovidrel® (choriogonadotropin alfa)
DRAFT Annotated Package Insert
Item 2, p. 1
Serono, Inc.
CONFIDENTIAL
FINAL 9/20/2000
Ovidrel
1
(choriogonadotropin alfa for injection)
2
FOR SUBCUTANEOUS USE
3
DESCRIPTION
4
Ovidrel® (choriogonadotropin alfa for injection) is a sterile lyophilized powder composed of
5
choriogonad... | custom-source | 2025-02-12T13:52:42.965455 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21149lbl.pdf', 'application_number': 21149, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,505 | 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 | 2025-02-12T13:52:43.053154 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21150lbl.pdf', 'application_number': 21150, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,498 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information ... | custom-source | 2025-02-12T13:52:43.132603 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021148s035lbl.pdf', 'application_number': 21148, 'submission_type': 'SUPPL ', 'submission_number': 35} |
14,506 | 1
69-5723-00-0.1
ZYRTEC-D 12 HOUR™
(cetirizine hydrochloride 5 mg and
pseudoephedrine hydrochloride 120 mg)
Extended Release Tablets
For Oral Use
DESCRIPTION
ZYRTEC-D 12 HOUR™ (cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg)
Extended Release Tablets for oral administration contain 5 mg of cetiri... | custom-source | 2025-02-12T13:52:43.258085 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21150se8-002_zyrtec_lbl.pdf', 'application_number': 21150, 'submission_type': 'SUPPL ', 'submission_number': 2} |
14,507 |
1
69-5723-00-2
ZYRTEC-D 12 HOUR
(cetirizine hydrochloride 5 mg and
pseudoephedrine hydrochloride 120 mg)
Extended Release Tablets
For Oral Use
DESCRIPTION
ZYRTEC-D 12 HOUR™ (cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg)
Extended Release Tablets for oral administration contai... | custom-source | 2025-02-12T13:52:43.433737 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19835slr016,21150slr005,30346slr011_zyrtec_lbl.pdf', 'application_number': 21150, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,509 |
structural formula
BETAPACE AF
® (sotalol HCl)
6700802
To minimize the risk of induced arrhythmia, patients initiated or re-initiated on Betapace AF
should be placed for a minimum of three days (on their maintenance dose) in a facility that can
provide cardiac resuscitation, continuous electr... | custom-source | 2025-02-12T13:52:43.583282 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021151s009lbl.pdf', 'application_number': 21151, 'submission_type': 'SUPPL ', 'submission_number': 9} |
14,508 | February 7, 2000
1
“WHAT YOU SHOULD KNOW ABOUT BETAPACE AFTM ”
(Bay’ tah pace)
(generic name: sotalol hydrochloride)
This summary contains important patient information that has been reviewed and approved by the U.S.
Food and Drug Administration. This summary is not meant to take the place of your doctor’s instructio... | custom-source | 2025-02-12T13:52:43.781592 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21151lbl.pdf', 'application_number': 21151, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,510 |
NDA 021152/S-002
Page 3
CUTIVATE (fluticasone propionate) Lotion
PharmaDerm, A division of Nycomed US Inc.
Rx Only
FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
DESCRIPTION
CUTIVATE® (fluticasone propionate) Lotion, 0.05% contains fluticasone propio... | custom-source | 2025-02-12T13:52:43.795738 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021152s002lbl.pdf', 'application_number': 21152, 'submission_type': 'SUPPL ', 'submission_number': 2} |
14,511 |
... | custom-source | 2025-02-12T13:52:43.914010 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021152s004lbl.pdf', 'application_number': 21152, 'submission_type': 'SUPPL ', 'submission_number': 4} |
14,512 | NDA 21-153/S-015
Page 3
NEXIUM®
(esomeprazole magnesium)
DELAYED-RELEASE CAPSULES
Rx only
DESCRIPTION
The active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release
Capsules
is
bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-
pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydra... | custom-source | 2025-02-12T13:52:44.105851 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153slr015_nexium_lbl.pdf', 'application_number': 21153, 'submission_type': 'SUPPL ', 'submission_number': 15} |
14,515 | NDA 21-153/S-022
Page 3
NEXIUM®
(esomeprazole magnesium)
DELAYED-RELEASE CAPSULES
Rx only
DESCRIPTION
The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules is bis(5-
methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl)
magnesium trihy... | custom-source | 2025-02-12T13:52:44.209200 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s022lbl.pdf', 'application_number': 21153, 'submission_type': 'SUPPL ', 'submission_number': 22} |
14,514 | NDA 21-153/S-021
Page 3
NEXIUM®
(esomeprazole magnesium)
DELAYED-RELEASE CAPSULES
Rx only
DESCRIPTION
The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules is bis(5-
methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl)
magnesium trihydr... | custom-source | 2025-02-12T13:52:44.483122 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s021lbl.pdf', 'application_number': 21153, 'submission_type': 'SUPPL ', 'submission_number': 21} |
14,516 | NDA 21-153/S-024
Page 3
NEXIUM®
(esomeprazole magnesium)
DELAYED-RELEASE CAPSULES
Rx only
DESCRIPTION
The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules is bis(5-
methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl)
magnesium trihy... | custom-source | 2025-02-12T13:52:44.584168 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s024lbl.pdf', 'application_number': 21153, 'submission_type': 'SUPPL ', 'submission_number': 24} |
14,517 | NDA 21-153/S025
Page 3
NEXIUM®
(esomeprazole magnesium)
DELAYED-RELEASE CAPSULES
Rx only
DESCRIPTION
The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules is bis(5-
methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl)
magnesium trihydra... | custom-source | 2025-02-12T13:52:44.698961 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s025lbl.pdf', 'application_number': 21153, 'submission_type': 'SUPPL ', 'submission_number': 25} |
14,513 | NDA 21-153/S-020
Page 3
NEXIUM®
(esomeprazole magnesium)
DELAYED-RELEASE CAPSULES
Rx only
DESCRIPTION
The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules is bis(5-
methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl)
magnesium trihydrate, a co... | custom-source | 2025-02-12T13:52:44.915395 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021153s020lbl.pdf', 'application_number': 21153, 'submission_type': 'SUPPL ', 'submission_number': 20} |
14,518 | NDA 21-153/S-027
NDA 21-689/S-008
Page 3
NEXIUM®
(esomeprazole magnesium)
DELAYED-RELEASE CAPSULES
NEXIUM®
(esomeprazole magnesium)
FOR DELAYED-RELEASE ORAL SUSPENSION
Rx only
DESCRIPTION
The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules and
NEXIUM (esomeprazole ... | custom-source | 2025-02-12T13:52:45.140242 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf', 'application_number': 21153, 'submission_type': 'SUPPL ', 'submission_number': 28} |
14,519 |
40 mg
Twice Daily
-----------------------DOSAGE FORMS AND STRENGTHS-----------------
•
•
NEXIUM Delayed-Release Capsules, 20 mg and 40 mg (3)
NEXIUM For Delayed-Release Oral Suspension, 10 ... | custom-source | 2025-02-12T13:52:45.326518 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s031,021957s003,022101s001lbl.pdf', 'application_number': 21153, 'submission_type': 'SUPPL ', 'submission_number': 31} |
14,520 |
_______________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:52:45.569286 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022101s004,021153s034,021957s007,021689s015lbl.pdf', 'application_number': 21153, 'submission_type': 'SUPPL ', 'submission_number': 34} |
14,521 |
______________________________________________________________________________________________________________... | custom-source | 2025-02-12T13:52:45.730099 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s005,021153s035,021957s008lbl.pdf', 'application_number': 21153, 'submission_type': 'SUPPL ', 'submission_number': 35} |
14,522 |
______________________________________________________________________________________________________________________... | custom-source | 2025-02-12T13:52:45.944969 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s007,021153s038,021957s010lbl.pdf', 'application_number': 21153, 'submission_type': 'SUPPL ', 'submission_number': 38} |
14,523 |
... | custom-source | 2025-02-12T13:52:46.005066 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s040,021957s011,022101s008lbl.pdf', 'application_number': 21153, 'submission_type': 'SUPPL ', 'submission_number': 40} |
14,524 |
... | custom-source | 2025-02-12T13:52:46.271535 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,022101s009lbl.pdf', 'application_number': 21153, 'submission_type': 'SUPPL ', 'submission_number': 42} |
14,526 |
... | custom-source | 2025-02-12T13:52:46.600336 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s044,021957s014,022101s011lbl.pdf', 'application_number': 21153, 'submission_type': 'SUPPL ', 'submission_number': 44} |
14,527 |
... | custom-source | 2025-02-12T13:52:46.827018 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s049,021957s016,022101s013lbl.pdf', 'application_number': 21153, 'submission_type': 'SUPPL ', 'submission_number': 49} |
14,525 |
... | custom-source | 2025-02-12T13:52:46.834425 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s043_02195sS013_02210s010lbl.pdf', 'application_number': 21153, 'submission_type': 'SUPPL ', 'submission_number': 43} |
14,528 | SB-265805/Prescribing Information
00003
April 3, 2003 version
PRESCRIBING INFORMATION
FACTIVE® brand of gemifloxacin mesylate tablets.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
FACTIVE and other antibacterial drugs, FACTIVE should be used only to treat infections
that are pr... | custom-source | 2025-02-12T13:52:46.941442 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021158lbl.pdf', 'application_number': 21158, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,529 | Page 1 of 31
PRESCRIBING INFORMATION
1
2
FACTIVE®
3
(gemifloxacin mesylate) Tablets
4
5
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
6
FACTIVE and other antibacterial drugs, FACTIVE should be used only to treat
7
infections that are proven or strongly suspecte... | custom-source | 2025-02-12T13:52:47.291910 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021158s007lbl.pdf', 'application_number': 21158, 'submission_type': 'SUPPL ', 'submission_number': 7} |
14,532 |
WARNING:
Fluoroquinolones, including FACTIVE®, are associated with an increased risk of
tendinitis and tendon rupture in all ages. This risk is further increased in older patients
usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with
kidney, heart or lung ... | custom-source | 2025-02-12T13:52:47.476863 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021158s022lbl.pdf', 'application_number': 21158, 'submission_type': 'SUPPL ', 'submission_number': 22} |
14,531 |
s
t
ru
ct
ural
formu
la
PRESCRIBING I... | custom-source | 2025-02-12T13:52:47.737041 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021158s021lbl.pdf', 'application_number': 21158, 'submission_type': 'SUPPL ', 'submission_number': 21} |
14,530 |
PRESCRIBING INFORMATION
FACTIVE®
(gemifloxacin mesylate) Tablets
WARNING:
Fluoroquinolones, including FACTIVE®, are associated with an increased risk of
tendinitis and tendon rupture in all ages. This risk is further increased in older
patients usually over 60 years of age, in p... | custom-source | 2025-02-12T13:52:47.776967 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021158s012lbl.pdf', 'application_number': 21158, 'submission_type': 'SUPPL ', 'submission_number': 12} |
14,534 |
NDA 21-162/S-019/S-020
Page 3 Boehringer Ingelheim
Micardis HCT
(telmisartan and hydrochlorothiazide)
Tablets, 40 mg/12.5 mg
80 mg/12.5 mg and 80 mg/25 mg
Rx only
Prescribing Information
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, dru... | custom-source | 2025-02-12T13:52:47.906636 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021162s019s020lbl.pdf', 'application_number': 21162, 'submission_type': 'SUPPL ', 'submission_number': 20} |
14,535 |
s
tr
uct
ur
a
l
formula
company logo
Micardis® HCT
(telmisartan and hydrochlorothiazide)
Tablets, 40 mg/12.5 mg
80 mg/12.5 mg and 80 mg/25 mg
Rx only
Prescribing Information
USE IN PREGNANCY
When used in pregnancy during the secon... | custom-source | 2025-02-12T13:52:48.189612 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s030lbl.pdf', 'application_number': 21162, 'submission_type': 'SUPPL ', 'submission_number': 30} |
14,533 |
... | custom-source | 2025-02-12T13:52:48.217280 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021158s023lbl.pdf', 'application_number': 21158, 'submission_type': 'SUPPL ', 'submission_number': 23} |
14,537 |
s
tr
uct
ur
a
l
formula
company logo
Micardis® HCT
(telmisartan and hydrochlorothiazide)
Tablets, 40 mg/12.5 mg
80 mg/12.5 mg and 80 mg/25 mg
Rx only
Prescribing Information
WARNING: FETAL TOXICITY
When pregnancy is detected, disco... | custom-source | 2025-02-12T13:52:48.317425 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s034lbl.pdf', 'application_number': 21162, 'submission_type': 'SUPPL ', 'submission_number': 34} |
14,536 |
s
tr
uc
tu
ra
l
form
ul
a
s
tr
uct
ur
a
l
formula
company logo
Micardis® HCT
(telmisartan and hydrochlorothiazide)
Tablets, 40 mg/12.5 mg
80 mg/12.5 mg and 80 mg/25 mg
Rx only
Prescribing Information
USE IN PREGNANCY
When used in p... | custom-source | 2025-02-12T13:52:48.414560 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021162s029s031lbl.pdf', 'application_number': 21162, 'submission_type': 'SUPPL ', 'submission_number': 31} |
14,538 |
Micardis® HCT
(telmisartan and hydrochlorothiazide)
Tablets, 40 mg/12.5 mg
80 mg/12.5 mg and 80 mg/25 mg
Rx only
Prescribing Information
WARNING: FETAL TOXICITY
•
When pregnancy is detected, discontinue MICARDIS HCT as soon as possible.
•
Drugs that act directly on the renin-angiotensi... | custom-source | 2025-02-12T13:52:48.568881 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s035lbl.pdf', 'application_number': 21162, 'submission_type': 'SUPPL ', 'submission_number': 35} |
14,541 | DESCRIPTION: CLARINEX (desloratadine) Tablets are light blue, round, film coated tablets con-
taining 5 mg desloratadine, an antihistamine, to be administered orally. It also contains the fol-
lowing excipients: dibasic calcium phosphate dihydrate USP, microcrystalline cellulose NF, corn
starch NF, talc USP, carnauba ... | custom-source | 2025-02-12T13:52:48.683536 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21165lbl.pdf', 'application_number': 21165, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,540 | Artwork Release
1st Proofread
______________________
______________________
________
Print Name
Signature
Date
2nd Proofread
______________________
______________________
________
Print Name
Signature
Date
Project Leader
______________________
______________________
________
Print Name
Signature
Date
MEDICATION DELIVER... | custom-source | 2025-02-12T13:52:48.747058 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21163s011lbl.pdf', 'application_number': 21163, 'submission_type': 'SUPPL ', 'submission_number': 11} |
14,539 | custom-source | 2025-02-12T13:52:48.756512 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21163lbl.pdf', 'application_number': 21163, 'submission_type': 'ORIG ', 'submission_number': 1} | |
14,544 |
5000718-1137
E01306 ARev2 01/2008
EstroGel® 0.06%
(estradiol gel)
WARNINGS
ENDOMETRIAL CANCER
Adequate diagnostic measures, including endometrial sampling when indicated, should be
undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal
vaginal bleeding. (See... | custom-source | 2025-02-12T13:52:49.134309 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021166s007lbl.pdf', 'application_number': 21166, 'submission_type': 'SUPPL ', 'submission_number': 7} |
14,543 | 1
1
500123
1E Rev 2/2004
ESTROGEL® 0.06%
(estradiol gel)
2
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate
diagnostic measures, including endometrial sampling when indicated, should be
undertaken to rule out malignancy in all cases of u... | custom-source | 2025-02-12T13:52:49.151864 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21166_estrogel_lbl.pdf', 'application_number': 21166, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,542 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
CLARINEX® safely and effectively. See full prescribing
information for CLARINEX.
CLARINEX® Tablets, RediTabs and Oral Solution(desloratadine)
for oral use
Initial U.S. Approval: 2001
----------------------... | custom-source | 2025-02-12T13:52:49.246976 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021165s014lbl.pdf', 'application_number': 21165, 'submission_type': 'SUPPL ', 'submission_number': 14} |
14,545 |
... | custom-source | 2025-02-12T13:52:49.379676 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021166s010lbl.pdf', 'application_number': 21166, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,547 | FDA Approved Labeling Text for NDA 21-168
Page 1 of 18
August 4, 2000
(No. 7126)
NEW
DEPAKOTE® ER
DIVALPROEX SODIUM
EXTENDED-RELEASE TABLETS
Rx Only
BOX WARNING:
HEPATOTOXICITY:
HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS RECEIVING VALPROIC ACID
AND ITS DERIVATIVES. EXPERIENCE HAS INDICATED THAT C... | custom-source | 2025-02-12T13:52:49.526121 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21168lbl.pdf', 'application_number': 21168, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,546 | T2000-08
89008101
Vivelle®
estradiol transdermal system
Continuous delivery for twice-weekly application
Rx only
Prescribing Information
ESTROGENS
HAVE
BEEN
REPORTED
TO
INCREASE
THE
RISK
OF
ENDOMETRIAL CARCINOMA IN POSTMENOPAUSAL WOMEN.
Close clinical surveillance of all women taking estrogens is important. Ade... | custom-source | 2025-02-12T13:52:49.763180 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf', 'application_number': 21167, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,548 |
Package Insert
Page 1
(No. 3826 and 7126)
NEW
DEPAKOTE® ER
DIVALPROEX SODIUM
EXTENDED-RELEASE TABLETS
Rx Only
BOX WARNING:
HEPATOTOXICITY:
HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS RECEIVING VALPROIC ACID
AND ITS DERIVATIVES. EXPERIENCE HAS INDICATED THAT CHILDREN UNDER... | custom-source | 2025-02-12T13:52:49.939876 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21168s1lbl.pdf', 'application_number': 21168, 'submission_type': 'SUPPL ', 'submission_number': 1} |
14,549 | DN0797V3 CR23-00674
August 14, 2003
Page 1
(No. 3826 and, 7126)
03-5235-R4-Rev. December, 2002 NEW
DEPAKOTE® ER
DIVALPROEX SODIUM
EXTENDED-RELEASE TABLETS
Rx Only
BOX WARNING:
HEPATOTOXICITY:
HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS RECEIVING VALPROIC ACID
AND ITS DERIVATIVES. EXPERIENCE HAS IN... | custom-source | 2025-02-12T13:52:50.003753 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21168se5-007_depakote_lbl.pdf', 'application_number': 21168, 'submission_type': 'SUPPL ', 'submission_number': 7} |
14,551 | Final Agreed Upon Labeling
Page 1 of 23
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Depakote ER safely and effectively. See full prescribing information for
Depakote ER.
Depakote ER (divalproex sodium) extended release tablets for oral
adminis... | custom-source | 2025-02-12T13:52:50.937967 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021168s015lbl.pdf', 'application_number': 21168, 'submission_type': 'SUPPL ', 'submission_number': 15} |
14,553 | NDA 021168/S-016/S-017/S-020/S-022
Depakote ER (divalproex sodium) Tablet, Extended Release for Oral use
FDA Approved Labeling Text dated October 7, 2011
Page 1 of 66
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Depakote ER safely and effectively. See f... | custom-source | 2025-02-12T13:52:51.258255 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf', 'application_number': 21168, 'submission_type': 'SUPPL ', 'submission_number': 20} |
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