id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
13,623 | 3
PRESCRIBING INFORMATION
COMBIVIR®
(lamivudine/zidovudine)
Tablets
WARNING
ZIDOVUDINE, ONE OF THE TWO ACTIVE INGREDIENTS IN COMBIVIR, HAS
BEEN ASSOCIATED WITH HEMATOLOGIC TOXICITY INCLUDING
NEUTROPENIA AND SEVERE ANEMIA, PARTICULARLY IN PATIENTS WITH
ADVANCED HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE (S... | custom-source | 2025-02-12T13:50:38.006643 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020857s020lbl.pdf', 'application_number': 20857, 'submission_type': 'SUPPL ', 'submission_number': 20} |
13,624 | NDA 20-857/S-021
Page 3
PRESCRIBING INFORMATION
COMBIVIR®
(lamivudine/zidovudine)
Tablets
WARNING
ZIDOVUDINE, ONE OF THE TWO ACTIVE INGREDIENTS IN COMBIVIR, HAS
BEEN ASSOCIATED WITH HEMATOLOGIC TOXICITY INCLUDING NEUTROPENIA
AND SEVERE ANEMIA, PARTICULARLY IN PATIENTS WITH ADVANCED HUMAN
IMMUNODEFICI... | custom-source | 2025-02-12T13:50:38.195395 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020857s021lbl.pdf', 'application_number': 20857, 'submission_type': 'SUPPL ', 'submission_number': 21} |
13,626 |
HIGHLIGHTS OF PRESCR... | custom-source | 2025-02-12T13:50:38.621231 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020857s028lbl.pdf', 'application_number': 20857, 'submission_type': 'SUPPL ', 'submission_number': 28} |
13,625 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
COMBIVIR safely and effectively. See full prescribing information for
COMBIVIR.
COMBIVIR~ (lamivudine and zidovudine) Tablets iso mg/300 mg
Initial U.S. Approval: 1997
WARNING: RISK OF HEMATOLOGIC TOXICITY, MYO... | custom-source | 2025-02-12T13:50:38.890906 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020857s023lbl.pdf', 'application_number': 20857, 'submission_type': 'SUPPL ', 'submission_number': 23} |
13,627 |
... | custom-source | 2025-02-12T13:50:38.981647 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/20857s030lbl.pdf', 'application_number': 20857, 'submission_type': 'SUPPL ', 'submission_number': 30} |
13,628 | 20859 S009, 011 FDA Approved Labeling Text 12.10.07
1
Sonata®
(zaleplon)
Capsules
CIV
RX only
DESCRIPTION
Zaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class. The chemical name of zaleplon is
N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide. Its empirical formula... | custom-source | 2025-02-12T13:50:38.993745 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020859s011lbl.pdf', 'application_number': 20859, 'submission_type': 'SUPPL ', 'submission_number': 11} |
13,629 | DESCRIPTION
Doxercalciferol, the active ingredient in Hectorol, is a synthetic vitamin D2 analog that
undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-
(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Hectorolis
available as soft gelatin capsules containing 0.5 m... | custom-source | 2025-02-12T13:50:39.920586 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020862s019,021027s013lbl.pdf', 'application_number': 20862, 'submission_type': 'SUPPL ', 'submission_number': 19} |
13,630 |
... | custom-source | 2025-02-12T13:50:39.950782 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020862s023lbl.pdf', 'application_number': 20862, 'submission_type': 'SUPPL ', 'submission_number': 23} |
13,631 |
----------
... | custom-source | 2025-02-12T13:50:39.978484 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020862s024lbl.pdf', 'application_number': 20862, 'submission_type': 'SUPPL ', 'submission_number': 24} |
13,632 |
ggeennzzyym
mee
Hectorol® (doxercalciferol capsules)
APPROVED TEXT OF THE LABELING OF THE DRUG
1
HECTOROL® (doxercalciferol capsules)
2
DESCRIPTION
3
Doxercalciferol, the active ingredient in Hectorol®, is a synthetic vitamin D2 analog that
4
undergoes metabolic activation in vivo to form 1α,2... | custom-source | 2025-02-12T13:50:40.226950 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020862s030lbl.pdf', 'application_number': 20862, 'submission_type': 'SUPPL ', 'submission_number': 30} |
13,636 |
PLETAL®
(PLAY-tal)
(cilostazol) (sil-OS-tah-zol)
Tablets
CONTRAINDICATION
PLETAL is contraindicated in patients with congestive heart... | custom-source | 2025-02-12T13:50:40.317940 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s022lbl.pdf', 'application_number': 20863, 'submission_type': 'SUPPL ', 'submission_number': 22} |
13,634 | NDA 20-863/S-019
Page 3
PLETAL
(PLAY-tal)
(cilostazol) (sil-OS-tah-zol)
Tablets
CONTRAINDICATION
Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with this pharmacologic effect
have caused decreased survival compared to placebo in patients with class III-... | custom-source | 2025-02-12T13:50:40.441204 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020863s019lbl.pdf', 'application_number': 20863, 'submission_type': 'SUPPL ', 'submission_number': 19} |
13,635 | NDA 20-863/S-021
Page 2
PLETAL
(PLAY-tal)
(cilostazol) (sil-OS-tah-zol)
Tablets
CONTRAINDICATION
Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with this pharmacologic effect
have caused decreased survival compared to placebo in patients with class III-... | custom-source | 2025-02-12T13:50:40.616799 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020863s021lbl.pdf', 'application_number': 20863, 'submission_type': 'SUPPL ', 'submission_number': 21} |
13,639 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
MAXALT and MAXALT-MLT safely and effectively. See full
prescribing information for MAXALT and MAXALT-MLT.
MAXA... | custom-source | 2025-02-12T13:50:40.866605 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf', 'application_number': 20864, 'submission_type': 'SUPPL ', 'submission_number': 17} |
13,637 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
PLETAL safely and effectively. See full prescribing information for
PLETAL.
PLETAL (cilostazol) tablets, for oral use.
Initial U.S. Approval: 1999
WARNING: CONTRAINDICATED IN HEART FAILURE
PATIENTS
S... | custom-source | 2025-02-12T13:50:40.887620 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s023lbl.pdf', 'application_number': 20863, 'submission_type': 'SUPPL ', 'submission_number': 23} |
13,640 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
MAXALT and MAXALT-MLT safely and effectively. See full
prescribing information for MAXALT and MAXALT-MLT.
MAXA... | custom-source | 2025-02-12T13:50:41.026552 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf', 'application_number': 20864, 'submission_type': 'SUPPL ', 'submission_number': 18} |
13,638 | 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 | 2025-02-12T13:50:41.046682 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20864lbl.pdf', 'application_number': 20864, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,641 | 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 | 2025-02-12T13:50:41.166976 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20864lbl.pdf', 'application_number': 20865, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,642 | c
o
mpany logo
MAXALT®
(RIZATRIPTAN BENZOATE)
TABLETS
MAXALT-MLT®
(RIZATRIPTAN BENZOATE)
ORALLY DISINTEGRATING TABLETS
DESCRIPTION
MAXALT* contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) ... | custom-source | 2025-02-12T13:50:41.237542 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020865s014lbl.pdf', 'application_number': 20865, 'submission_type': 'SUPPL ', 'submission_number': 14} |
13,643 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
MAXALT and MAXALT-MLT safely and effectively. See full
prescribing information for MAXALT and MAXALT-MLT.
MAXA... | custom-source | 2025-02-12T13:50:41.359803 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf', 'application_number': 20865, 'submission_type': 'SUPPL ', 'submission_number': 16} |
13,644 |
... | custom-source | 2025-02-12T13:50:41.529474 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020866s008lbl.pdf', 'application_number': 20866, 'submission_type': 'SUPPL ', 'submission_number': 8} |
13,645 |
... | custom-source | 2025-02-12T13:50:41.618823 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020866s009lbl.pdf', 'application_number': 20866, 'submission_type': 'SUPPL ', 'submission_number': 9} |
13,647 |
Flagyl® ER
metronidazole extended release tablets
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
Flagyl ER and other antibacterial drugs, Flagyl ER should be used only to treat or prevent
infections that are proven or strongly suspected to be caused ... | custom-source | 2025-02-12T13:50:41.689147 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020868s008lbl.pdf', 'application_number': 20868, 'submission_type': 'SUPPL ', 'submission_number': 8} |
13,646 | Flagyl® ER
(metronidazole extended release tablets)
750 mg
WARNING
Metronidazole has been shown to be carcinogenic in mice and rats. (See PRECAUTIONS.)
Unnecessary use of drug should be avoided. Its use should be reserved for conditions
described in the INDICATIONS AND USAGE section below.
DESCRIPTION
Metronidazole is ... | custom-source | 2025-02-12T13:50:41.719380 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020868s005lbl.pdf', 'application_number': 20868, 'submission_type': 'SUPPL ', 'submission_number': 5} |
13,651 | NDA 20869/S040
Page 3
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
COSOPT safely and effectively. See full prescribing information
for COSOPT.
COSOPT® (dorzolamide hydrochloride-timolol maleate ophthalmic
solution)
Initial U.S. Approval: 1998
---------... | custom-source | 2025-02-12T13:50:42.018910 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020869s040lbl.pdf', 'application_number': 20869, 'submission_type': 'SUPPL ', 'submission_number': 40} |
13,649 |
NDA 20-869/S-034
Page 3
COSOPT®
(dorzolamide hydrochloride-timolol maleate ophthalmic solution)
Sterile Ophthalmic Solution
DESCRIPTION
COSOPT... | custom-source | 2025-02-12T13:50:42.206928 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020869s034lbl.pdf', 'application_number': 20869, 'submission_type': 'SUPPL ', 'submission_number': 34} |
13,648 | NDA 20-869/S-020
Page 3
COSOPT®
(dorzolamide hydrochloride-timolol maleate ophthalmic solution)
Sterile Ophthalmic Solution
DESCRIPTION
COSOPT® (dorzolamide hydrochloride-timolol maleate ophthalmic solution) is the combination of
a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blo... | custom-source | 2025-02-12T13:50:42.259095 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020869s020lbl.pdf', 'application_number': 20869, 'submission_type': 'SUPPL ', 'submission_number': 20} |
13,650 |
NDA 20869/S-036
Page 4
COSOPT®
(dorzolamide hydrochloride-timolol maleate ophthalmic solution)
Sterile Ophthalmic Solution
... | custom-source | 2025-02-12T13:50:42.260834 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020869s036lbl.pdf', 'application_number': 20869, 'submission_type': 'SUPPL ', 'submission_number': 36} |
13,655 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the info... | custom-source | 2025-02-12T13:50:42.575219 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020872s018,021963s002lbl.pdf', 'application_number': 20872, 'submission_type': 'SUPPL ', 'submission_number': 18} |
13,654 | 1
Rev. September 2005
ALLEGRA®
(fexofenadine hydrochloride)
Tablets
DESCRIPTION
Fexofenadine hydrochloride, the active ingredient of ALLEGRA, is a histamine H1-receptor
antagonist with the chemical name (±)-4-[1 hydroxy-4-[4-(hydroxydiphenylmethyl)-1-
piperidinyl]-butyl]-α, α-dimethyl benzeneacetic acid h... | custom-source | 2025-02-12T13:50:42.690541 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020872s015lbl.pdf', 'application_number': 20872, 'submission_type': 'SUPPL ', 'submission_number': 15} |
13,652 | 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 | 2025-02-12T13:50:42.692533 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20870lbl.pdf', 'application_number': 20870, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,653 | NDA 20-870/S-013
Page 3
CombiPatch®
(estradiol/norethindrone acetate transdermal system)
Rx only
Prescribing Information
WARNING
Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia.
(See WARNINGS, Cardiovascular disorders and Dementia.)
The ... | custom-source | 2025-02-12T13:50:42.779192 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20870s013lbl.pdf', 'application_number': 20870, 'submission_type': 'SUPPL ', 'submission_number': 13} |
13,658 | ANGIOMAX
(bivalirudin) Injection
DESCRIPTION
Angiomax™ (bivalirudin) is a specific and reversible direct thrombin inhibitor. The active
substance is a synthetic, 20 amino acid peptide. The chemical name is D-phenylalanyl-L-prolyl-
L-arginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-aspartyl-L-phe... | custom-source | 2025-02-12T13:50:42.975284 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20873lbl.pdf', 'application_number': 20873, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,659 | LUNELLE Monthly Contraceptive Injection
medroxyprogesterone acetate and estradiol cypionate injectable suspension
Patients should be counseled that this product does not protect against HIV
infection (AIDS) and other sexually transmitted diseases.
DESCRIPTION
LUNELLE Monthly Contraceptive Injection contains medroxypr... | custom-source | 2025-02-12T13:50:43.112456 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20874lbl.pdf', 'application_number': 20874, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,656 |
Allegra Allergy 24hr IRC
8.09.11
ALG_$2_IRC_DD0070266-01 Package Labeling
Version 2:
IRC placed on existing PDP Package Labeling
IRC peeled open
Expiration Date: xx/xx/xx This coupon good only on
purchase of any Allegra® 24hr 30ct or higher. Any other
use constitutes fraud. Coupon not transferable. Limit o... | custom-source | 2025-02-12T13:50:43.453361 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s025lbl.pdf', 'application_number': 20872, 'submission_type': 'SUPPL ', 'submission_number': 25} |
13,660 | NDA 21-216, NDA 20-235/S-015, NDA 20-882/S-002, NDA 21-129/S-005
Page 1
FDA approved labeling text (dated 10/12/00)
Neurontin® (gabapentin) capsules,
Neurontin® (gabapentin) tablets
Neurontin® (gabapentin) oral solution
DESCRIPTION
Neurontin® (gabapentin) capsules, Neurontin® (gabapentin) tablets, and Neurontin®
(gabap... | custom-source | 2025-02-12T13:50:43.501750 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21216lbl.pdf', 'application_number': 20882, 'submission_type': 'SUPPL ', 'submission_number': 2} |
13,661 | NDA 20-235/S-029; NDA 20-882/S-015; NDA 21-129/S-016
FDA Approved Labeling Text dated February 2005
Page 1 of 29
Neurontin® (gabapentin) Capsules
Neurontin® (gabapentin) Tablets
Neurontin®(gabapentin) Oral Solution
DESCRIPTION
Neurontin® (gabapentin) Capsules, Neurontin® (gabapentin) Tablets, and Neu... | custom-source | 2025-02-12T13:50:43.689694 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20235s029,20882s015,21129s016lbl.pdf', 'application_number': 20882, 'submission_type': 'SUPPL ', 'submission_number': 15} |
13,657 | 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 | 2025-02-12T13:50:43.744091 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s031bl.pdf', 'application_number': 20872, 'submission_type': 'SUPPL ', 'submission_number': 31} |
13,663 |
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 | 2025-02-12T13:50:43.855890 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf', 'application_number': 20882, 'submission_type': 'SUPPL ', 'submission_number': 39} |
13,662 |
NDA 020235/S-050
NDA 020882/S-035
NDA 021129/S-033
FDA Approved Labeling Text dated 8/10/2011
Page 1
Neurontin® (gabapentin) Capsules
Neurontin® (gabapentin) Tablets
Neurontin® (gabapentin) Oral Solution
DESCRIPTION
Neurontin® (gabapentin) Capsules, Neurontin (gabapentin) Tablets, an... | custom-source | 2025-02-12T13:50:43.985910 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s050,020882s035,021129s033lbl.pdf', 'application_number': 20882, 'submission_type': 'SUPPL ', 'submission_number': 35} |
13,664 | ACOVATM (argatroban) Injection
DESCRIPTION
Argatroban is a synthetic direct thrombin inhibitor derived from L-arginine. The chemical
name for argatroban is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-
methyl-8-quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid,
monohydrate. Arga... | custom-source | 2025-02-12T13:50:44.075582 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20883lbl.pdf', 'application_number': 20883, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,665 |
NDA 20-883/S-014
Page 4
PRESCRIBING INFORMATION
ARGATROBAN
Injection
DESCRIPTION
Argatroban is a synthetic direct thrombin inhibitor derived from L-arginine. The chemical
name for Argatroban is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-... | custom-source | 2025-02-12T13:50:44.181198 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020883s014lbl.pdf', 'application_number': 20883, 'submission_type': 'SUPPL ', 'submission_number': 14} |
13,666 |
... | custom-source | 2025-02-12T13:50:44.433391 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020883s016lbl.pdf', 'application_number': 20883, 'submission_type': 'SUPPL ', 'submission_number': 16} |
13,667 | 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 | 2025-02-12T13:50:44.466885 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20884s1lbl.pdf', 'application_number': 20884, 'submission_type': 'SUPPL ', 'submission_number': 1} |
13,668 | NDA 20--84/S-012
Page 2
Note to Pharmacist: Dispense in this unit-of-use container. If repackaging is requested, use USP
tight containers with not more than 60 capsules per container.
Aggrenox
(aspirin/extended-release dipyridamole)
25 mg/200 mg capsules
Rx only
Prescribing Information
DESCRIPTION
A... | custom-source | 2025-02-12T13:50:44.506650 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020884s012lbl.pdf', 'application_number': 20884, 'submission_type': 'SUPPL ', 'submission_number': 12} |
13,669 | NDA 20-884/S-014
Page 3
Note to Pharmacist: Dispense in this unit-of-use container. If repackaging is requested, use USP tight
containers with not more than 60 capsules per container.
Aggrenox®
(aspirin/extended-release dipyridamole)
25 mg/200 mg capsules
Rx only
Prescribing Information
DESCRIPTION... | custom-source | 2025-02-12T13:50:44.607112 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020884s014lbl.pdf', 'application_number': 20884, 'submission_type': 'SUPPL ', 'submission_number': 14} |
13,670 | Panretin
(alitretinoin)
gel 0.1%
(For topical use only)
Description
Panretin gel 0.1% contains alitretinoin and is intended for topical application only. The
chemical name is 9-cis-retinoic acid and the structural formula is as follows:
Chemically, alitretinoin is related to vitamin A. It is a yellow powder with ... | custom-source | 2025-02-12T13:50:44.699138 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20886lbl.pdf', 'application_number': 20886, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,671 | 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 | 2025-02-12T13:50:44.884406 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20887lbl.pdf', 'application_number': 20887, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,672 | 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 | 2025-02-12T13:50:44.898781 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20889s2lbl.pdf', 'application_number': 20889, 'submission_type': 'SUPPL ', 'submission_number': 2} |
13,673 | ANTHRA PHARMACEUTICALS, INC.
AD 32
NDA 20,892
1
Valstar
(valrubicin)
Sterile Solution for Intravesical Instillation
For Intravesical Use Only
Not for IV or IM Use
DESCRIPTION
Valrubicin (N-trifluoroacetyladriamycin-14-valerate), a semisynthetic analog of the anthracycline
doxorubicin, is a cytotoxic agent with the ... | custom-source | 2025-02-12T13:50:45.018014 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20892lbl.pdf', 'application_number': 20892, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,674 |
VALSTAR ®
(valrubicin)
Sterile Solution for Intravesical Instillation
For Intravesical Use Only
Not for IV or IM Use
Rx Only
DESCRIPTION
Valrubicin (N-trifluoroacetyladriamycin-14-valerate), a semisynthetic analog ... | custom-source | 2025-02-12T13:50:45.078925 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020892s013lbl.pdf', 'application_number': 20892, 'submission_type': 'SUPPL ', 'submission_number': 13} |
13,675 | 1
69-5485-00-2
VIAGRA®
(sildenafil citrate)
Tablets
DESCRIPTION
VIAGRA®, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective
inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro... | custom-source | 2025-02-12T13:50:45.369370 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/viagralabel2.pdf', 'application_number': 20895, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,677 | 69-5485-00-7.2
VIAGRA®
(sildenafil citrate)
Tablets
DESCRIPTION
VIAGRA®, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor
of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Sildenafil citrate is designated chemically as 1... | custom-source | 2025-02-12T13:50:45.373848 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20895s11s15s18lbl.pdf', 'application_number': 20895, 'submission_type': 'SUPPL ', 'submission_number': 18} |
13,676 | 69-5485-00-7.2
VIAGRA®
(sildenafil citrate)
Tablets
DESCRIPTION
VIAGRA®, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor
of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Sildenafil citrate is designated chemically as 1... | custom-source | 2025-02-12T13:50:45.453760 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20895s11s15s18lbl.pdf', 'application_number': 20895, 'submission_type': 'SUPPL ', 'submission_number': 15} |
13,678 | NDA 20-895/S-020
Page 3
VIAGRA®
(sildenafil citrate)
Tablets
DESCRIPTION
VIAGRA®, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor
of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Sildenafil citrate is designated chemi... | custom-source | 2025-02-12T13:50:45.546108 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020895s20lbl.pdf', 'application_number': 20895, 'submission_type': 'SUPPL ', 'submission_number': 20} |
13,681 |
1
VIAGRA®
(sildenafil citrate)
Tablets
DESCRIPTION
VIAGRA®, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective
inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Sildenafil citrate is designated chemically as 1-[[3-(6,7-dih... | custom-source | 2025-02-12T13:50:45.768736 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020895s026lbl.pdf', 'application_number': 20895, 'submission_type': 'SUPPL ', 'submission_number': 26} |
13,679 | NDA 20-895/S-021
Page 3
LAB-0221-2.4
VIAGRA®
(sildenafil citrate)
Tablets
DESCRIPTION
VIAGRA®, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor
of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Sildenafil citrate i... | custom-source | 2025-02-12T13:50:45.868229 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020895s021lbl.pdf', 'application_number': 20895, 'submission_type': 'SUPPL ', 'submission_number': 21} |
13,682 |
VIAGRA®
(sildenafil citrate)
Tablets
DESCRIPTION
VIAGRA®, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective
inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Sildenafil citrate is designated chemically as... | custom-source | 2025-02-12T13:50:45.966740 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020895s033lbl.pdf', 'application_number': 20895, 'submission_type': 'SUPPL ', 'submission_number': 33} |
13,680 | NDA 20-895/S-023
Page 3
VIAGRA®
(sildenafil citrate)
Tablets
DESCRIPTION
VIAGRA®, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor
of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Sildenafil citrate is designated che... | custom-source | 2025-02-12T13:50:46.051120 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020895s023lbl.pdf', 'application_number': 20895, 'submission_type': 'SUPPL ', 'submission_number': 23} |
13,683 |
... | custom-source | 2025-02-12T13:50:46.233867 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020895s045lbl.pdf', 'application_number': 20895, 'submission_type': 'SUPPL ', 'submission_number': 45} |
13,684 | XELODA®
(capecitabine)
TABLETS
DESCRIPTION: XELODA (capecitabine) is a fluoropyrimidine carbamate with antineoplastic
activity. It is an orally administered systemic prodrug of 5’-deoxy-5-fluorouridine (5’-DFUR) which is
converted to 5-fluorouracil.
The chemical name for capecitabine is 5’-deoxy-5-fluoro-N-[(pentyloxy)... | custom-source | 2025-02-12T13:50:47.154838 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20896S6lbl.pdf', 'application_number': 20896, 'submission_type': 'SUPPL ', 'submission_number': 9} |
13,686 | HLR 02/21/03
C:\Data\My Documents\NDAs\20896\SLR-012\PI 022103 Clean Copy.doc
1
XELODA®
(capecitabine)
TABLETS
WARNING
XELODA Warfarin Interaction: Patients receiving concomitant capecitabine and oral coumarin-
derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin
time) monitored... | custom-source | 2025-02-12T13:50:47.835022 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20896slr012_xeloda_lbl.pdf', 'application_number': 20896, 'submission_type': 'SUPPL ', 'submission_number': 12} |
13,687 |
... | custom-source | 2025-02-12T13:50:47.882280 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020896s036lbl.pdf', 'application_number': 20896, 'submission_type': 'SUPPL ', 'submission_number': 36} |
13,688 |
... | custom-source | 2025-02-12T13:50:48.171105 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020896s037lbl.pdf', 'application_number': 20896, 'submission_type': 'SUPPL ', 'submission_number': 37} |
13,690 |
1
DITROPAN®
(oxybutynin chloride)
Tablets and Syrup
DESCRIPTION
Each scored biconvex, engraved blue DITROPAN® (oxybutynin chloride) Tablet
contains 5 mg of oxybutynin chloride. Each 5 mL of DITROPAN Syrup contains
5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d,l (racemic)
4-diethylamino-2... | custom-source | 2025-02-12T13:50:48.316925 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,020897s018lbl.pdf', 'application_number': 20897, 'submission_type': 'SUPPL ', 'submission_number': 18} |
13,689 | NDA 17-577 DITROPAN (oxybutynin chloride) Tablets (Final Draft submitted 4/9/2003)
NDA 18-211 DITROPAN (oxybutynin chloride) Syrup (Final Draft submitted 4/9/2003)
1
DITROPAN®
(oxybutynin chloride)
Tablets and Syrup
DESCRIPTION
Each scored biconvex, engraved blue DITROPAN (oxybutynin chloride) Tablet contains
5 mg o... | custom-source | 2025-02-12T13:50:48.360767 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf', 'application_number': 20897, 'submission_type': 'SUPPL ', 'submission_number': 9} |
13,685 | HLR 9/7/01
C:\Data\My Documents\NDAs\20896\SE7_010_Phase4\Xeloda_Taxotere PI 090701_clean.doc
1
1
XELODA®
2
(capecitabine)
3
TABLETS
4
WARNING
XELODA Warfarin Interaction: Patients receiving concomitant capecitabine and oral coumarin-
derivative anticoagulant therapy should have their anticoagulant response (INR or pro... | custom-source | 2025-02-12T13:50:50.060111 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20896S1011lbl.pdf', 'application_number': 20896, 'submission_type': 'SUPPL ', 'submission_number': 10} |
13,691 |
DITROPAN XL®
(oxybutynin chloride)
Extended Release Tablets
DESCRIPTION
DITROPAN XL® (oxybutynin chloride) is an antispasmodic, anticholinergic agent.
Each DITROPAN XL Extended Release Tablet contains 5 mg, 10 mg, or 15 mg of
oxybutynin chloride U... | custom-source | 2025-02-12T13:50:50.244460 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020897s024lbl.pdf', 'application_number': 20897, 'submission_type': 'SUPPL ', 'submission_number': 24} |
13,693 |
DITROPAN XL®
(oxybutynin chloride)
Extended Release Tablets
DESCRIPTION
DITROPAN XL® (oxybutynin chloride) is an antispasmodic, anticholinergic agent. Each
DITROPAN XL® Extended Release Tablet contains 5 mg, 10 mg, or 15 mg of oxybutynin
chloride USP, formulated as a once-a-day controlled-release table... | custom-source | 2025-02-12T13:50:50.249719 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020897s031lbl.pdf', 'application_number': 20897, 'submission_type': 'SUPPL ', 'submission_number': 31} |
13,692 |
DITROPAN XL®
(oxybutynin chloride)
Extended Release Tablets
DESCRIPTION
DITROPAN XL® (oxybutynin chloride) is an antispasmodic, anticholinergic agent. Each
DITROPAN XL® Extended Release Tablet contains 5 mg, 10 mg, or 15 mg of oxybutynin
chloride USP, formulated as a once-a-day controlled-release tablet for o... | custom-source | 2025-02-12T13:50:50.297568 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020897s028lbl.pdf', 'application_number': 20897, 'submission_type': 'SUPPL ', 'submission_number': 28} |
13,696 |
----------
THYROGEN - thyrotropin alfa injection, powder, for solution
THYROGEN - thyrotropin alfa
Genzyme Corporation
DESCRIPTION
Thyrogen® (thyrotropin alfa for injection) contains a highly purified recombinant form of human
thyroid stimulating hormone (TSH), a glycoprotein which is prod... | custom-source | 2025-02-12T13:50:50.587781 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020898s038lbl.pdf', 'application_number': 20898, 'submission_type': 'SUPPL ', 'submission_number': 38} |
13,697 | (Logo) Thyrogen
thyrotropin alfa for injection
DESCRIPTION
Thyrogen® (thyrotropin alfa for injection) contains a highly purified recombinant form of
human thyroid stimulating hormone (TSH), a glycoprotein which is produced by
recombinant DNA technology. Thyrotropin alfa is synthesized in a genetically modified
C... | custom-source | 2025-02-12T13:50:50.878808 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020898s051lbl.pdf', 'application_number': 20898, 'submission_type': 'SUPPL ', 'submission_number': 51} |
13,694 | ggeennzzyym
mee
Thyrogen(thyrotropin alfa for injection)
PROPOSED TEXT OF THE LABELING OF THE DRUG
August 2003
Proprietary and Confidential
Page 1
(Logo) Thyrogen
1
(thyrotropin alfa for injection)
2
DESCRIPTION
3
Thyrogen® (thyrotropin alfa for injection) contains a highly purified recombinant form of
4
human ... | custom-source | 2025-02-12T13:50:50.920116 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20898slr021_Thyrogen_lbl.pdf', 'application_number': 20898, 'submission_type': 'SUPPL ', 'submission_number': 21} |
13,695 | (Logo) Thyrogen
thyrotropin alfa for injection
DESCRIPTION
Thyrogen® (thyrotropin alfa for injection) contains a highly purified recombinant form of
human thyroid stimulating hormone (TSH), a glycoprotein which is produced by
recombinant DNA technology. Thyrotropin alfa is synthesized in a genetically modified
C... | custom-source | 2025-02-12T13:50:51.022893 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020898s029lbl.pdf', 'application_number': 20898, 'submission_type': 'SUPPL ', 'submission_number': 29} |
13,698 | OPTISON™
(Perflutren Protein-Type A Microspheres Injectable Suspension, USP)
DESCRIPTION
OPTISON™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) is a
sterile non-pyrogenic suspension of microspheres of human serum albumin with
perflutren for contrast enhancement during the indicated ultrasou... | custom-source | 2025-02-12T13:50:51.066360 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020899s007lbl.pdf', 'application_number': 20899, 'submission_type': 'SUPPL ', 'submission_number': 7} |
13,699 | MetroLotion
®
Rx only
(metronidazole lotion)
Topical Lotion, 0.75%
FOR TOPICAL USE ONLY
(NOT FOR OPHTHALMIC USE)
DESCRIPTION
MetroLotion® (metronidazole lotion) Topical Lotion contains metronidazole,
USP, at a concentration of 7.5 mg per gram (0.75% w/w) in a lotion consist-
ing of benzyl alcohol, carbomer 941, cyclome... | custom-source | 2025-02-12T13:50:51.152302 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20901slr002_metrolotion_lbl.pdf', 'application_number': 20901, 'submission_type': 'SUPPL ', 'submission_number': 2} |
13,700 | CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER: 020902
PRINTED LABELING
| custom-source | 2025-02-12T13:50:51.226920 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020902A_Pepcid_prntlbl.pdf', 'application_number': 20902, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,701 | 1
J:\Shared\BUSKA\REBETOL\21617628.rtf
F-21617628
PRODUCT
INFORMATION
REBETRON™
Combination Therapy
containing
REBETOL® (ribavirin, USP) Capsules
and
INTRON® A (interferon alfa-2b, recombinant) Injection
CONTRAINDICATIONS AND WARNINGS
Combination REBETOL/INTRON A therapy is contraindicated in women who are pregna... | custom-source | 2025-02-12T13:50:51.446068 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20903s1lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 2} |
13,704 | 4
F-XXXXXXXX
PRODUCT
INFORMATION
REBETOL® (ribavirin, USP) Capsules
• REBETOL monotherapy is not effective for the treatment of chronic hepatitis C virus
infection and should not be used alone for this indication. (See WARNINGS).
• The primary toxicity of ribavirin is hemolytic anemia. The anemia associated with
R... | custom-source | 2025-02-12T13:50:51.819967 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 12} |
13,702 | NDA 20-903/S-005
Page 3
Attachment:
1. Clean copy of May 17, 2000 Final Printed Labeling.
F-21676144
MEDICATION
GUIDE
(pen)
REBETRON™
Combination Therapy
containing
REBETOL®
(ribavirin, USP) Capsules
and
INTRON® A
(interferon alfa-2b, recombinant)
Injection
You and your partner must not become pregnant while either of ... | custom-source | 2025-02-12T13:50:51.993787 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s5lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 5} |
13,703 | ProposedPI_boxed warning
Page 3 of 22
F-21617687
PRODUCT
INFORMATION
REBETRON™
Combination Therapy containing
REBETOL® (ribavirin, USP) Capsules and
INTRON® A (interferon alfa-2b, recombinant) Injection
CONTRAINDICATIONS AND WARNINGS
Combination REBETOL/INTRON A therapy is contraindicated in women who are
pregnant and... | custom-source | 2025-02-12T13:50:52.447555 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s10lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 10} |
13,706 | ProposedPI_boxed warning
Page 3 of 25
F-XXXXXXXX
PRODUCT
INFORMATION
REBETRON™
Combination Therapy containing
REBETOL® (ribavirin, USP) Capsules and
INTRON® A (interferon alfa-2b, recombinant) Injection
CONTRAINDICATIONS AND WARNINGS
Combination REBETOL/INTRON A therapy is contraindicated in women who are
pregnant ... | custom-source | 2025-02-12T13:50:52.716954 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s14lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 14} |
13,705 |
6
1
PRODUCT
2
INFORMATION
3
REBETRON™
4
Combination Therapy
5
containing
6
REBETOL® (ribavirin, USP) Capsules
7
and
8
INTRON® A (interferon alfa-2b, recombinant) Injection
9
10
11
CONTRAINDICATIONS AND WARNINGS
12
Combination REBETOL/INTRON A therapy is contraindicated in females w... | custom-source | 2025-02-12T13:50:52.719984 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s13lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 13} |
13,707 | NDA 20-903/S-023
Page 4
4
PRODUCT
INFORMATION
REBETRON™
Combination Therapy
containing
REBETOL® (ribavirin, USP) Capsules
and
INTRON® A (interferon alfa-2b, recombinant) Injection
CONTRAINDICATIONS AND WARNINGS
Combination REBETOL/INTRON A therapy is contraindicated in females who are ... | custom-source | 2025-02-12T13:50:53.185348 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20903s23lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 23} |
13,709 | PAGE 4
F-XXXXXXXX
PRODUCT
INFORMATION
REBETOL® (ribavirin, USP) Capsules and Oral Solution
•
REBETOL monotherapy is not effective for the treatment of chronic hepatitis C virus
infection and should not be used alone for this indication. (See WARNINGS).
•
The primary toxicity of ribavirin is h... | custom-source | 2025-02-12T13:50:53.511927 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903slr032_rebetol_lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 32} |
13,710 | NDA 20-903/S-033
Page 4
PRODUCT
INFORMATION
REBETRON™
Combination Therapy
containing
REBETOL® (ribavirin, USP) Capsules
and
INTRON® A (interferon alfa-2b, recombinant) Injection
CONTRAINDICATIONS AND WARNINGS
Combination REBETOL/INTRON A therapy is contraindicated in females who are
pregnant a... | custom-source | 2025-02-12T13:50:54.159627 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20903slr033_rebetron_lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 33} |
13,708 |
PRODUCT
INFORMATION
REBETOL® (ribavirin, USP) Capsules
•
REBETOL monotherapy is not effective for the treatment of chronic hepatitis C virus infection and
should not be used alone for this indication. (See WARNINGS).
•
The primary toxicity of ribavirin is hemolytic anemia. The anemia associated... | custom-source | 2025-02-12T13:50:54.395689 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903slr029_rebetol_lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 29} |
13,712 | NDA 20-903/S-039
Page 3
03-28-07-final draft PI
F-XXXXXXXX
PRODUCT
INFORMATION
REBETOL® (ribavirin, USP) Capsules and Oral Solution
•
REBETOL MONOTHERAPY IS NOT EFFECTIVE FOR THE TREATMENT OF CHRONIC HEPATITIS C VIRUS
INFECTION AND SHOULD NOT BE USED ALONE FOR THIS INDICATION. (SEE WARNINGS).
•
TH... | custom-source | 2025-02-12T13:50:54.615084 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020903s039lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 39} |
13,711 | NDA 20-903
SLR 034
4
F-XXXXXXXX
PRODUCT
INFORMATION
REBETOL® (ribavirin, USP) Capsules and Oral Solution
• REBETOL monotherapy is not effective for the treatment of chronic hepatitis C
virus infection and should not be used alone for this indication. (See WARNINGS).
• The primary toxicity of riba... | custom-source | 2025-02-12T13:50:54.758120 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20903slr034_rebetol_lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 34} |
13,713 |
112807.final draft PI -F-XXXXXXXX
PRODUCT
INFORMATION
REBETOL® (ribavirin, USP) Capsules and Oral Solution
•
REBETOL MONOTHERAPY IS NOT EFFECTIVE FOR THE TREATMENT OF CHRONIC HEPATITIS C VIRUS
INFECTION AND SHOULD NOT BE USED ALONE FOR THIS INDICATION. (SEE WARNINGS.)
•
THE PRIMARY TOXICITY OF RIBAVIRIN ... | custom-source | 2025-02-12T13:50:54.910543 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020903s040lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 40} |
13,715 |
110609. Final draft PI
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
REBETOL safely and effectively. See full pre... | custom-source | 2025-02-12T13:50:55.569518 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 45} |
13,714 |
110609. Final draft PI
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
REBETOL safely and effectively. See full pre... | custom-source | 2025-02-12T13:50:55.736757 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 42} |
13,716 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
REBETOL safely and effectively. See full prescribing information
for REBETOL.
REBETOL (... | custom-source | 2025-02-12T13:50:56.541540 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020903s046,021546s002lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 46} |
13,717 | USPI-MTL-89081306
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
REBETOL safely and effectively. See full prescribing information
for REBETOL.
REBETOL® (ribavirin USP) capsules, for oral use
REBETOL® (ribavirin USP) oral solution
Initial U.S. Approval: ... | custom-source | 2025-02-12T13:50:56.672436 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s052,021546s008lbl.pdf', 'application_number': 20903, 'submission_type': 'SUPPL ', 'submission_number': 52} |
13,718 | 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 | 2025-02-12T13:50:56.705444 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20905lbl.pdf', 'application_number': 20905, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,719 | NDA 20-905/S-006
NDA 20-905/S-007
Page 4
Rev. XXX
ARAVA Tablets
(leflunomide)
10 mg, 20 mg, 100 mg
Rx only
CONTRAINDICATIONS AND WARNINGS
PREGNANCY MUST BE EXCLUDED BEFORE THE START OF TREATMENT WITH
ARAVA. ARAVA IS CONTRAINDICATED IN PREGNANT WOMEN, OR WOMEN OF
CHILDBEARING POTENTIAL WHO ARE NOT US... | custom-source | 2025-02-12T13:50:56.779519 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20905slr007,20905se1-006_arava_lbl.pdf', 'application_number': 20905, 'submission_type': 'SUPPL ', 'submission_number': 6} |
13,721 | ARAVA® Tablets
(leflunomide)
10 mg, 20 mg, 100 mg
Rx only
CONTRAINDICATIONS AND WARNINGS
Pregnancy
Pregnancy must be excluded before the start of treatment with ARAVA. ARAVA is
contraindicated in pregnant women, or women of childbearing potential who are not using
reliable contraception. (see CONTRAINDIC... | custom-source | 2025-02-12T13:50:57.132270 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020905s020lbl.pdf', 'application_number': 20905, 'submission_type': 'SUPPL ', 'submission_number': 20} |
13,720 | NDA 20-905/S-016
Page 3
ARAVA® Tablets
(leflunomide)
10 mg, 20 mg, 100 mg
Rx only
CONTRAINDICATIONS AND WARNINGS
PREGNANCY MUST BE EXCLUDED BEFORE THE START OF TREATMENT WITH
ARAVA. ARAVA IS CONTRAINDICATED IN PREGNANT WOMEN, OR WOMEN OF
CHILDBEARING POTENTIAL WHO ARE NOT USING RELIABLE CONTRACEPTION.... | custom-source | 2025-02-12T13:50:57.209099 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020905s016lbl.pdf', 'application_number': 20905, 'submission_type': 'SUPPL ', 'submission_number': 16} |
13,723 |
... | custom-source | 2025-02-12T13:50:57.363835 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020905s027lbl.pdf', 'application_number': 20905, 'submission_type': 'SUPPL ', 'submission_number': 27} |
13,722 |
ARAVA Tablets
(leflunomide)
10 mg, 20 mg, 100 mg
Rx only
CONTRAINDICATIONS AND WARNINGS
Pregnancy
Pregnancy must be excluded before the start of treatment with ARAVA. ARAVA is
contraindicated in pregnant women, or women of childbearing potential who are not using
reliable cont... | custom-source | 2025-02-12T13:50:57.467730 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020905s025lbl.pdf', 'application_number': 20905, 'submission_type': 'SUPPL ', 'submission_number': 25} |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.