id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
12,890 |
... | custom-source | 2025-02-12T13:48:54.305064 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf', 'application_number': 20634, 'submission_type': 'SUPPL ', 'submission_number': 67} |
12,893 | 1
PROPOSED TEXT OF THE LABELING FOR LEVAQUIN
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Text of Proposed Labeling
LEVAQUIN® (levofloxacin) Tablets
LEVAQUIN® (levofloxacin) Injection
LEVAQUIN® (levofloxacin In 5% dextrose)... | custom-source | 2025-02-12T13:48:54.677813 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,034lbl.pdf', 'application_number': 20635, 'submission_type': 'SUPPL ', 'submission_number': 33} |
12,896 | LEVAQUIN (levofloxacin) TABLETS
LEVAQUIN (levofloxacin) ORAL SOLUTION
LEVAQUIN (levofloxacin) INJECTION
LEVAQUIN (levofloxacin in 5% dextrose) INJECTION
To reduce the development of drug-resistant bacteria and maintain the effectiveness
of LEVAQUIN (levofloxacin) and other antibacterial drugs, LEVAQUIN should... | custom-source | 2025-02-12T13:48:55.210686 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s040,020635s043,021721s007lbl.pdf', 'application_number': 20635, 'submission_type': 'SUPPL ', 'submission_number': 43} |
12,894 | 1
PROPOSED TEXT OF THE LABELING FOR LEVAQUIN
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Text of Proposed Labeling
LEVAQUIN® (levofloxacin) Tablets
LEVAQUIN® (levofloxacin) Injection
LEVAQUIN® (levofloxacin In 5% dextrose)... | custom-source | 2025-02-12T13:48:55.212924 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,034lbl.pdf', 'application_number': 20635, 'submission_type': 'SUPPL ', 'submission_number': 34} |
12,895 | LEVAQUIN (levofloxacin) TABLETS
LEVAQUIN (levofloxacin) ORAL SOLUTION
LEVAQUIN (levofloxacin) INJECTION
LEVAQUIN (levofloxacin in 5% dextrose) INJECTION
To reduce the development of drug-resistant bacteria and maintain the effectiveness
of LEVAQUIN (levofloxacin) and other antibacterial drugs, LEVAQUIN should... | custom-source | 2025-02-12T13:48:55.221981 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s039,020635s042,021721s006lbl.pdf', 'application_number': 20635, 'submission_type': 'SUPPL ', 'submission_number': 42} |
12,897 |
1
LEVAQUIN® (levofloxacin) TABLETS
LEVAQUIN® (levofloxacin) ORAL SOLUTION
LEVAQUIN® (levofloxacin) INJECTION
LEVAQUIN® (levofloxacin in 5% dextrose) INJECTION
To reduce the development of drug-resistant bacteria and maintain the effectiveness
of LEVAQUIN® (levofloxacin) and other antibacterial drugs, LEVAQUIN s... | custom-source | 2025-02-12T13:48:55.474961 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s044,020635s047,021721s012lbl.pdf', 'application_number': 20635, 'submission_type': 'SUPPL ', 'submission_number': 47} |
12,898 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
LEVAQUIN® safely and effectively. See full prescribing information for
LEVAQUIN®.
LEVAQUIN® (levofloxacin) Tablets
LEVAQUIN® (levofloxacin) Oral Solution
LEVAQUIN® (levofloxacin) Injection, for Intravenou... | custom-source | 2025-02-12T13:48:56.205146 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s050,020635s054,021721s018lbl.pdf', 'application_number': 20635, 'submission_type': 'SUPPL ', 'submission_number': 54} |
12,899 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the in... | custom-source | 2025-02-12T13:48:56.649130 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020634s051,020635s055,021721s019lbl.pdf', 'application_number': 20635, 'submission_type': 'SUPPL ', 'submission_number': 55} |
12,900 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlig... | custom-source | 2025-02-12T13:48:57.140935 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021721s020_020635s57_020634s52_lbl.pdf', 'application_number': 20635, 'submission_type': 'SUPPL ', 'submission_number': 57} |
12,901 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
LEVAQUIN® safely and effectively. See full prescribing information
for LEVAQUIN.
LEVAQUIN® (levofloxacin) Tablet, Film Coated for Oral use
LEVAQUIN® (levofloxacin) Solution for Oral use
LEVAQUIN® (levofloxac... | custom-source | 2025-02-12T13:48:57.380059 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf', 'application_number': 20635, 'submission_type': 'SUPPL ', 'submission_number': 68} |
12,902 | NDA 20-636/S-022
NDA 20-933/S-012
Page 3
Viramune®
(nevirapine) Tablets
Viramune®
(nevirapine) Oral Suspension
Rx only
WARNING
Severe, life-threatening, and in some cases fatal hepatotoxicity, including fulminant
and cholestatic hepatitis, hepatic necrosis and hepatic failure, has been reported in
... | custom-source | 2025-02-12T13:48:57.477955 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20636slr022_viramune_lbl.pdf', 'application_number': 20636, 'submission_type': 'SUPPL ', 'submission_number': 22} |
12,903 | ATTENTION PHARMACISTS: Detach “Medication Guide” and dispense with the
product.
1
2
3
Viramune®
(nevirapine) Tablets
Viramune®
(nevirapine) Oral Suspension
4
5
6
Rx only
WARNING
Severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in the first 18
7
weeks, has been reported ... | custom-source | 2025-02-12T13:48:57.568533 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020636s026,020933s015lbl.pdf', 'application_number': 20636, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,906 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
VIRAMUNE safely and effectively. See full ... | custom-source | 2025-02-12T13:48:57.988626 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020636s044,020933s035lbl.pdf', 'application_number': 20636, 'submission_type': 'SUPPL ', 'submission_number': 44} |
12,904 |
HIGHLIGHTS OF PRE... | custom-source | 2025-02-12T13:48:58.188525 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020933s022,020636s032lbl.pdf', 'application_number': 20636, 'submission_type': 'SUPPL ', 'submission_number': 32} |
12,905 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
VIRAMUNE safely and effectively. See full prescribing information for
VIRAMUNE.
Viramune® (nevirapine) tablets 200 mg
Viramune® (nevirapine) oral suspension 50 mg/5 mL
Initial U.S. Approval: 1996
WARNING:... | custom-source | 2025-02-12T13:48:58.248006 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020933s028,020636s037lbl.pdf', 'application_number': 20636, 'submission_type': 'SUPPL ', 'submission_number': 37} |
12,907 |
1
SEROQUEL
(quetiapine fumarate) TABLETS
DESCRIPTION
SEROQUEL (quetiapine fumarate) is a psychotropic agent belonging
to a chemical class, the dibenzothiazepine derivatives. The chemical
designation
is
2-[2-(4-dibenzo
[b,f]
[1,4]thiazepin-11-yl-1-
piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It... | custom-source | 2025-02-12T13:48:58.364627 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639se1-017,016_seroquel_lbl.pdf', 'application_number': 20639, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,908 | 1
Rev 06/05
SIC 30139-00
SEROQUEL®
(quetiapine fumarate)
TABLETS
Rx only
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with atypical antipsychotic
drugs are at an increased risk of death compared to placebo. Analyses of s... | custom-source | 2025-02-12T13:48:58.471871 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020639s023lbl.pdf', 'application_number': 20639, 'submission_type': 'SUPPL ', 'submission_number': 23} |
12,909 | NDA 20-639 S-026
Final Agreed Upon Labeling
1
Rev
SIC
SEROQUEL®
(quetiapine fumarate)
TABLETS
RX ONLY
Increased Mortality in Elderly Patients with Dementia-
Related Psychosis
Elderly patients with dementia-related psychosis treated
with atypical antipsychotic drugs are at an increased risk
of death ... | custom-source | 2025-02-12T13:48:58.587443 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020639s026lbl.pdf', 'application_number': 20639, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,910 |
_____________________________________________________________________________________________________________________
Final Agreed-Upon Labeling
HIGHLIGH... | custom-source | 2025-02-12T13:48:59.075131 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf', 'application_number': 20639, 'submission_type': 'SUPPL ', 'submission_number': 37} |
12,911 |
... | custom-source | 2025-02-12T13:48:59.767572 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020639s045s046lbl.pdf', 'application_number': 20639, 'submission_type': 'SUPPL ', 'submission_number': 45} |
12,912 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
The... | custom-source | 2025-02-12T13:49:00.091433 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020639s052lbl.pdf', 'application_number': 20639, 'submission_type': 'SUPPL ', 'submission_number': 52} |
12,913 |
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL
THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights ... | custom-source | 2025-02-12T13:49:00.092181 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf', 'application_number': 20639, 'submission_type': 'SUPPL ', 'submission_number': 53} |
12,914 |
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL
THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights ... | custom-source | 2025-02-12T13:49:00.231647 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf', 'application_number': 20639, 'submission_type': 'SUPPL ', 'submission_number': 58} |
12,917 | F-19649873
1711
PRODUCT
INFORMATION
CLARITIN®
brand of loratadine
TABLETS, SYRUP, and
RAPIDLY-DISINTEGRATING TABLETS
DESCRIPTION Loratadine is a white to off-white powder not soluble in water, but very soluble in acetone, alcohol, and
chloroform. It has a molecular weight of 382.89, and empirical formula of C22H23CIN2... | custom-source | 2025-02-12T13:49:00.508339 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20641s7lbl.pdf', 'application_number': 20641, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,915 |
... | custom-source | 2025-02-12T13:49:00.696372 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s061lbl.pdf', 'application_number': 20639, 'submission_type': 'SUPPL ', 'submission_number': 61} |
12,916 |
... | custom-source | 2025-02-12T13:49:01.128492 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020639s064lbl.pdf', 'application_number': 20639, 'submission_type': 'SUPPL ', 'submission_number': 64} |
12,920 |
NDA 020646/S-018
FDA Approved Labeling dated 11/03/15
GABITRIL®
(tiagabine hydrochloride)
Tablets
Rx only
DESCRIPTION
GABITRIL® (tiagabine HCl) is a... | custom-source | 2025-02-12T13:49:01.173543 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020646s018lbl.pdf', 'application_number': 20646, 'submission_type': 'SUPPL ', 'submission_number': 18} |
12,919 | 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 | 2025-02-12T13:49:01.290928 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s040lbl.pdf', 'application_number': 20641, 'submission_type': 'SUPPL ', 'submission_number': 40} |
12,921 |
NDA 20-647/S-006 and S-007
Page 3
ELD:R19C.3
ELDEPRYL®
(SELEGILINE HYDROCHLORIDE)
CAPSULES
Rx only
DESCRIPTION: ELDEPRYL (selegiline hydrochloride) is a levorotatory acetylenic derivative of
phenethylamine. It is commonly referred... | custom-source | 2025-02-12T13:49:01.506030 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020647s006s007lbl.pdf', 'application_number': 20647, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,918 | Reference ID: 3735285
000 ..
...
000
~~
[ 45.24]
NO TEXT
NO COLOR
NO VARNISH
Do •Ill•• W yam haVImr had an allergic naction to
this pradiiC!or any of its ingrediants.
Alk 1 -actar •mn~•all yau •nvllver or kldnr,"
d~BISII. Your doctDr should ditlrmlna H you naad a
dlllenmtdosll.
VIIBI111111111111 ,radlll do... | custom-source | 2025-02-12T13:49:01.624636 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s036lbl.pdf', 'application_number': 20641, 'submission_type': 'SUPPL ', 'submission_number': 36} |
12,922 | NDA 20-649/SLR-015
Page 3
edex®
(alprostadil for injection)
For Intracavernous Use Only
Sterile Powder and Diluent
(sterile 0.9% sodium chloride) in Cartridges
Rx Only
PC4766A
Rev. 01/06
DESCRIPTION edex® (alprostadil for injection) is a sterile, pyrogen-free powder containing
alprostadil in an a... | custom-source | 2025-02-12T13:49:01.740612 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020649s015lbl.pdf', 'application_number': 20649, 'submission_type': 'SUPPL ', 'submission_number': 15} |
12,923 | 200178-08
[Code 39 bar code]
Alora®
(estradiol transdermal system)
Continuous Delivery for Twice Weekly Dosing
PRESCRIBING INFORMATION
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER.
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic
measures, including endometrial sampling ... | custom-source | 2025-02-12T13:49:01.859447 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20655slr006_alora_lbl.pdf', 'application_number': 20655, 'submission_type': 'SUPPL ', 'submission_number': 6} |
12,924 | NDA20-655/S-008
Page 3
3
Estradiol Matrix
Transdermal Delivery System
NDA 20-655/S-008
Package Insert
Watson Laboratories Inc.
Research Park
417 Wakara Way
Salt Lake City, UT 84108 USA
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:49:02.199344 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20655s8lbl.pdf', 'application_number': 20655, 'submission_type': 'SUPPL ', 'submission_number': 8} |
12,925 | custom-source | 2025-02-12T13:49:02.339978 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf', 'application_number': 20657, 'submission_type': 'SUPPL ', 'submission_number': 4} | |
12,927 |
SPORANOX®
(itraconazole)
Oral Solution
Congestive Heart Failure: When itraconazole was administered intravenously to
dogs and healthy human volunteers, negative inotropic effects were seen. If signs
or symptoms of congestive heart failure occur during admin... | custom-source | 2025-02-12T13:49:02.507682 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf', 'application_number': 20657, 'submission_type': 'SUPPL ', 'submission_number': 19} |
12,926 |
SPORANOX®
(itraconazole)
Oral Solution
Congestive Heart Failure: When itraconazole was administered intravenously to
dogs and healthy human volunteers, negative inotropic effects were seen. If signs
or symptoms of congestive heart failure occur during admin... | custom-source | 2025-02-12T13:49:02.512793 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf', 'application_number': 20657, 'submission_type': 'SUPPL ', 'submission_number': 11} |
12,929 | SPORANOX®
(itraconazole)
Oral Solution
BOXED WARNINGS
Congestive Heart Failure: When itraconazole was administered intravenously to dogs and
healthy human volunteers, negative inotropic effects were seen. If signs or symptoms of
congestive heart failure occur during administration of SPORANOX® (itraconazole) Oral... | custom-source | 2025-02-12T13:49:02.816940 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020657s025lbl.pdf', 'application_number': 20657, 'submission_type': 'SUPPL ', 'submission_number': 25} |
12,930 | SPORANOX®
(itraconazole)
Oral Solution
BOXED WARNINGS
Congestive Heart Failure: When itraconazole was administered intravenously to dogs and
healthy human volunteers, negative inotropic effects were seen. If signs or symptoms of
congestive heart failure occur during administration of SPORANOX® (itraconazole) Oral... | custom-source | 2025-02-12T13:49:03.308943 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020657s026lbl.pdf', 'application_number': 20657, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,928 |
structural formula
SPORANOX®
(itraconazole)
Oral Solution
BOXED WARNINGS
Congestive Heart Failure: When itraconazole was administered intravenously to dogs and
healthy human volunteers, negative inotropic effects were seen. If signs or symptoms of
congestive heart failure occur during administration ... | custom-source | 2025-02-12T13:49:03.345508 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020657s024lbl.pdf', 'application_number': 20657, 'submission_type': 'SUPPL ', 'submission_number': 24} |
12,932 |
SPORANOX®
(itraconazole)
Oral Solution
BOXED WARNINGS
Congestive Heart Failure, Cardiac Effects and Drug Interactions: When itraconazole was
administered intravenously to dogs and healthy human volunteers, negative inotropic effects
were seen. If signs or symptoms of congestive heart failure oc... | custom-source | 2025-02-12T13:49:03.453569 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020657s028lbl.pdf', 'application_number': 20657, 'submission_type': 'SUPPL ', 'submission_number': 28} |
12,931 |
SPORANOX®
(itraconazole)
Oral Solution
BOXED WARNINGS
Congestive Heart Failure, Cardiac Effects and Drug Interactions: When itraconazole was
administered intravenously to dogs and healthy human volunteers, negative inotropic effects
were seen. If signs or symptoms of congestive heart failure oc... | custom-source | 2025-02-12T13:49:03.643270 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020657s027lbl.pdf', 'application_number': 20657, 'submission_type': 'SUPPL ', 'submission_number': 27} |
12,935 |
NDA 20-658/S-020, S-018 and S-021
Page 3
PRESCRIBING INFORMATION
REQUIP®
(ropinirole hydrochloride)
Tablets
Patient Information Included
DESCRIPTION
REQUIP (ropinirole hydrochloride) is an orally administered non-ergoline dopamine agonist. It
i... | custom-source | 2025-02-12T13:49:04.228412 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020658s018s020s021lbl.pdf', 'application_number': 20658, 'submission_type': 'SUPPL ', 'submission_number': 20} |
12,934 | NDA 20-658/S-013
Page 4
RQ: 11
PRESCRIBING INFORMATION
REQUIP®
(ropinirole hydrochloride)
Tablets
Patient Information Included
DESCRIPTION
REQUIP (ropinirole hydrochloride) is an orally administered non-ergoline dopamine agonist. It
is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro... | custom-source | 2025-02-12T13:49:05.067363 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020658s013lbl.pdf', 'application_number': 20658, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,936 |
... | custom-source | 2025-02-12T13:49:05.075045 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf', 'application_number': 20658, 'submission_type': 'SUPPL ', 'submission_number': 30} |
12,933 |
SPORANOX®
(itraconazole)
Capsules
BOXED WARNING
Congestive Heart Failure, Cardiac Effects and Drug Interactions:
SPORANOX® (itraconazole) Capsules should not be administered for the treat... | custom-source | 2025-02-12T13:49:05.373224 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020083s058,020657s033lbl.pdf', 'application_number': 20657, 'submission_type': 'SUPPL ', 'submission_number': 33} |
12,937 | DN0622V8 CR 21-02994
July 6, 2001
Page 3 of 36
Attachment
(Nos. 1940 and 6633)
NEW
NORVIR®
(ritonavir capsules) Soft Gelatin
(ritonavir oral solution)
Rx only
DESCRIPTION
NORVIR (ritonavir) is an inhibitor of HIV protease with activity against the Human Immunodeficiency
Virus (HIV).
Ritonavir is chemically designated a... | custom-source | 2025-02-12T13:49:05.858064 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20945s5lbl.pdf', 'application_number': 20659, 'submission_type': 'SUPPL ', 'submission_number': 25} |
12,938 | NDA 20-659/S-030
NDA 20-945/S-013
Page 3
(ritonavir capsules) Soft Gelatin
(ritonavir oral solution)
Rx only
DESCRIPTION
NORVIR (ritonavir) is an inhibitor of HIV protease with activity against the Human
Immunodeficiency Virus (HIV).
Ritonavir is chemically designated as 10-Hydroxy-2-methyl-5-(1-methyl... | custom-source | 2025-02-12T13:49:06.774837 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20659slr030,20945slr013_norvir_lbl.pdf', 'application_number': 20659, 'submission_type': 'SUPPL ', 'submission_number': 30} |
12,939 |
Norvir®
DN1039V4 CR 25-00005144
(Nos. 1940 and 6633)
October 3, 2005
NEW
Page 1 of 48
1
NORVIR®
(ritonavir capsules) Soft Gelatin
(ritonavir oral solution)
Rx only
WARNING
CO-ADMINISTRATION OF NORVIR WITH CERTAIN NONSEDATING
ANTIHISTAMINES, SEDATIVE HYPNOTICS, ANTIARRHYTHMICS, OR ERGOT
ALKALOI... | custom-source | 2025-02-12T13:49:06.922562 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020659s034,020945s017lbl.pdf', 'application_number': 20659, 'submission_type': 'SUPPL ', 'submission_number': 34} |
12,940 |
FDA’s 8/29/08 approved draft PI
Page 1 of 46
NORVIR®
(ritonavir capsules) Soft Gelatin
(ritonavir oral solution)
WARNING
CO-ADMINISTRATION OF NORVIR WITH CERTAIN NONSEDATING
ANTIHISTAMINES, SEDATIVE HYPNOTICS, ANTIARRHYTHMICS, OR ERGOT
ALKALOID PREPARATIONS MAY RESULT IN POTENTIALLY SERIOUS... | custom-source | 2025-02-12T13:49:07.223967 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020945s022,020659s042lbl.pdf', 'application_number': 20659, 'submission_type': 'SUPPL ', 'submission_number': 42} |
12,941 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
NOR... | custom-source | 2025-02-12T13:49:07.446066 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020659s045lbl.pdf', 'application_number': 20659, 'submission_type': 'SUPPL ', 'submission_number': 45} |
12,943 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights d... | custom-source | 2025-02-12T13:49:09.015203 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020659s055,022417s006lbl.pdf', 'application_number': 20659, 'submission_type': 'SUPPL ', 'submission_number': 55} |
12,944 |
... | custom-source | 2025-02-12T13:49:09.186235 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020659s058_022417s010lbl.pdf', 'application_number': 20659, 'submission_type': 'SUPPL ', 'submission_number': 58} |
12,942 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
NORVIR ... | custom-source | 2025-02-12T13:49:09.280819 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020659s050,022417s001lbl.pdf', 'application_number': 20659, 'submission_type': 'SUPPL ', 'submission_number': 50} |
12,945 |
... | custom-source | 2025-02-12T13:49:09.364326 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s060,022417s012lbl.pdf', 'application_number': 20659, 'submission_type': 'SUPPL ', 'submission_number': 60} |
12,946 |
DESCRIPTION
DOSTINEX Tablets contain cabergoline, a dopamine receptor agonist. The chemical
name for cabergoline is 1-[(6-allylergolin-8ß-yl)-carbonyl]-1-[3-(dimethylamino)propyl]-
3-ethylurea. Its empirical formula is C26H37N5O2, and its molecular weight is 451.62. The
structural formula is as follows:
... | custom-source | 2025-02-12T13:49:09.663396 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020664s007lbl.pdf', 'application_number': 20664, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,948 |
company logo
DESCRIPTION
DOSTINEX Tablets contain cabergoline, a dopamine receptor agonist. The chemical
name for cabergoline is 1-[(6-allylergolin-8ß-yl)-carbonyl]-1-[3-(dimethylamino)
propyl]-3-ethylurea. Its empirical formula is C26H37N5O2, and its molecular weight is
451.62. The structu... | custom-source | 2025-02-12T13:49:09.837136 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020664s012lbl.pdf', 'application_number': 20664, 'submission_type': 'SUPPL ', 'submission_number': 12} |
12,947 |
Dostinex cabergoline tablets
DESCRIPTION
DOSTINEX Tablets contain cabergoline, a dopamine receptor agonist. The chemical
name for cabergoline is 1-[(6-allylergolin-8ß-yl)-carbonyl]-1-[3-(dimethylamino)
propyl]-3-ethylurea. Its empirical formula is C26H37N5O2, and its molecular weight is
451... | custom-source | 2025-02-12T13:49:10.082882 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020664s011lbl.pdf', 'application_number': 20664, 'submission_type': 'SUPPL ', 'submission_number': 11} |
12,949 |
... | custom-source | 2025-02-12T13:49:10.202313 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020665s034s035lbl.pdf', 'application_number': 20665, 'submission_type': 'SUPPL ', 'submission_number': 34} |
12,950 |
... | custom-source | 2025-02-12T13:49:10.249497 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020665s034s035lbl.pdf', 'application_number': 20665, 'submission_type': 'SUPPL ', 'submission_number': 35} |
12,951 |
... | custom-source | 2025-02-12T13:49:10.505694 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020665s038lbl.pdf', 'application_number': 20665, 'submission_type': 'SUPPL ', 'submission_number': 38} |
12,952 |
__________________
_________________
______________
______________
_____________
___________________
___________________
... | custom-source | 2025-02-12T13:49:11.012438 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020666s009lbl.pdf', 'application_number': 20666, 'submission_type': 'SUPPL ', 'submission_number': 9} |
12,953 | NDA 20-667/S-011/S-013
Page 4
Mirapex®
(pramipexole dihydrochloride)
0.125 mg, 0.25 mg, 0.5 mg,
1 mg, and 1.5 mg Tablets
Rx only
Prescribing Information
DESCRIPTION
MIRAPEX tablets contain pramipexole, a nonergot... | custom-source | 2025-02-12T13:49:11.185722 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020667s011s013lbl.pdf', 'application_number': 20667, 'submission_type': 'SUPPL ', 'submission_number': 11} |
12,954 |
NDA 20-667/S-014, S-017 and S-018
Page 3
Mirapex®
(pramipexole dihydrochloride)
0.125 mg, 0.25 mg, 0.5 mg,
1 mg, and 1.5 mg Tablets logo
Rx only
Prescribing Information
DESCRIPTION... | custom-source | 2025-02-12T13:49:11.355958 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf', 'application_number': 20667, 'submission_type': 'SUPPL ', 'submission_number': 14} |
13,169 |
NDA 20-667/S-014, S-017 and S-018
Page 3
Mirapex®
(pramipexole dihydrochloride)
0.125 mg, 0.25 mg, 0.5 mg,
1 mg, and 1.5 mg Tablets logo
Rx only
Prescribing Information
DESCRIPTION... | custom-source | 2025-02-12T13:49:11.427604 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf', 'application_number': 20667, 'submission_type': 'SUPPL ', 'submission_number': 17} |
13,172 |
______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:49:11.695632 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf', 'application_number': 20667, 'submission_type': 'SUPPL ', 'submission_number': 24} |
13,170 |
______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:49:11.995274 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf', 'application_number': 20667, 'submission_type': 'SUPPL ', 'submission_number': 19} |
13,171 |
______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:49:12.069573 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf', 'application_number': 20667, 'submission_type': 'SUPPL ', 'submission_number': 22} |
13,173 |
Mirapex®
(pramipexole dihydrochloride)
0.125 mg, 0.25 mg, 0.5 mg, company logo
0.75 mg, 1 mg,
and 1.5 mg Tablets
Rx only
Prescribing Information
DESCRIPTION
MIRAPEX tablets contain pramipexole, a nonergot dopamine... | custom-source | 2025-02-12T13:49:12.158489 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020667s025lbl.pdf', 'application_number': 20667, 'submission_type': 'SUPPL ', 'submission_number': 25} |
13,174 |
... | custom-source | 2025-02-12T13:49:12.354945 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbledt.pdf', 'application_number': 20667, 'submission_type': 'SUPPL ', 'submission_number': 30} |
13,175 |
... | custom-source | 2025-02-12T13:49:12.660077 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s033lbl.pdf', 'application_number': 20667, 'submission_type': 'SUPPL ', 'submission_number': 33} |
13,178 | NDA 20-668/S-011
Page 3
9176508
620008-08
LEXXEL
(enalapril maleate-felodipine ER)
TABLETS
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause
injury and even death to the developing fetus. When pregnancy is detected, LEXXEL should be
discontinued as ... | custom-source | 2025-02-12T13:49:12.843906 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20668slr011_lexxel_lbl.pdf', 'application_number': 20668, 'submission_type': 'SUPPL ', 'submission_number': 11} |
13,177 | NDA 20-668/S-005
Page 2
9176509
LEXXEL®
(enalapril maleate-felodipine ER)
TABLETS
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause
injury and even death to the develop... | custom-source | 2025-02-12T13:49:12.912920 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020668s005lbl.pdf', 'application_number': 20668, 'submission_type': 'SUPPL ', 'submission_number': 5} |
13,176 |
... | custom-source | 2025-02-12T13:49:12.978091 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s034lbl.pdf', 'application_number': 20667, 'submission_type': 'SUPPL ', 'submission_number': 34} |
13,179 | 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 | 2025-02-12T13:49:13.211282 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020670Orig1s014lbl.pdf', 'application_number': 20670, 'submission_type': 'SUPPL ', 'submission_number': 14} |
13,180 | NDA 20-671/S-004
Page 3
PRESCRIBING INFORMATION
HYCAMTINTM
brand of
topotecan hydrochloride
for Injection
(for intravenous use)
WARNING
Hycamtin (topotecan hydrochloride) for Injection should be administered under the supervision of a
physician experienced in the use of cancer chemotherapeutic agents. Appropriate mana... | custom-source | 2025-02-12T13:49:13.455319 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20671s4lbl.pdf', 'application_number': 20671, 'submission_type': 'SUPPL ', 'submission_number': 4} |
13,181 | HY:LXX
1
2
3
4
5
6
PRESCRIBING INFORMATION
HYCAMTIN®
(topotecan hydrochloride)
For Injection
FOR INTRAVENOUS USE
WARNING
7
HYCAMTIN (topotecan hydrochloride) for Injection should be administered under the
8
supervision of a physician experienced in the use of cancer chemotherapeutic agents.
9
Appropr... | custom-source | 2025-02-12T13:49:13.463978 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020671s014lbl.pdf', 'application_number': 20671, 'submission_type': 'SUPPL ', 'submission_number': 14} |
13,182 |
HIGHLIGH... | custom-source | 2025-02-12T13:49:13.789353 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020671s016s017lbl.pdf', 'application_number': 20671, 'submission_type': 'SUPPL ', 'submission_number': 17} |
13,184 | URSO 250® / URSO Forte®
Draft U.S. Package Insert
(ursodiol tablets, USP) 250 mg & 500 mg
URSO 250®
URSO Forte®
(Ursodiol Tablets, USP)
250 mg and 500 mg
Rx Only
DESCRIPTION
URSO 250® (ursodiol, 250 mg) is available as a film-coated tablet for oral administration. URSO Forte®
(ursodiol, 500 mg) is ava... | custom-source | 2025-02-12T13:49:13.833838 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020675s013lbl.pdf', 'application_number': 20675, 'submission_type': 'SUPPL ', 'submission_number': 13} |
13,185 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:49:13.876178 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020675s017lbl.pdf', 'application_number': 20675, 'submission_type': 'SUPPL ', 'submission_number': 17} |
13,183 |
... | custom-source | 2025-02-12T13:49:13.963885 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020671s020lbl.pdf', 'application_number': 20671, 'submission_type': 'SUPPL ', 'submission_number': 20} |
13,189 | ALESSE® 28 Tablets
(levonorgestrel and ethinyl estradiol tablets)
Rx only
Patients should be counseled that oral contraceptives do not protect against transmission of
HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital
herpes, genital warts, gonorrhea, hepatitis B, and syphilis. ... | custom-source | 2025-02-12T13:49:14.275170 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf', 'application_number': 20683, 'submission_type': 'SUPPL ', 'submission_number': 4} |
13,188 |
Glyset® (miglitol) tablets
For Oral Use
DESCRIPTION
GLYSET Tablets contain miglitol, an oral alpha-glucosidase inhibitor for use in the
management of non-insulin-dependent diabetes mellitus (NIDDM). Miglitol is a
desoxynojirimycin derivative, and is chemically known as 3,4,5-piperidinetriol, ... | custom-source | 2025-02-12T13:49:14.309413 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020682s010lbl.pdf', 'application_number': 20682, 'submission_type': 'SUPPL ', 'submission_number': 10} |
13,187 | Zagam
1
DESCRIPTION: Zagam® (sparfloxacin) tablets contain sparfloxacin, a synthetic
broad-spectrum antimicrobial agent for oral administration. Sparfloxacin, an
aminodifluoroquinolone, is 5-Amino-1-cyclopropyl-7-(cis-3,5-dimethyl-1-
piperazinyl)-6,8-difluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid. Its empirical
... | custom-source | 2025-02-12T13:49:14.346853 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020677s006lbl.pdf', 'application_number': 20677, 'submission_type': 'SUPPL ', 'submission_number': 6} |
13,190 | ALESSE® 28 Tablets
(levonorgestrel and ethinyl estradiol tablets)
Rx only
Patients should be counseled that oral contraceptives do not protect against transmission of
HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital
herpes, genital warts, gonorrhea, hepatitis B, and syphilis. ... | custom-source | 2025-02-12T13:49:14.611133 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf', 'application_number': 20683, 'submission_type': 'SUPPL ', 'submission_number': 7} |
13,186 | 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 | 2025-02-12T13:49:14.638800 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020676Orig1s009lbl.pdf', 'application_number': 20676, 'submission_type': 'SUPPL ', 'submission_number': 9} |
13,192 | CRIXIVAN® (indinavir sulfate) Capsules
9024517
4
CRIXIVAN®
(INDINAVIR SULFATE)
CAPSULES
DESCRIPTION
CRIXIVAN* (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV)
protease. CRIXIVAN Capsules are formulated as a sulfate salt and are available for oral
administration in strengths ... | custom-source | 2025-02-12T13:49:14.836967 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685slr046,047_crixivan_lbl.pdf', 'application_number': 20685, 'submission_type': 'SUPPL ', 'submission_number': 47} |
13,191 | CRIXIVAN® (indinavir sulfate) Capsules
9024517
4
CRIXIVAN®
(INDINAVIR SULFATE)
CAPSULES
DESCRIPTION
CRIXIVAN* (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV)
protease. CRIXIVAN Capsules are formulated as a sulfate salt and are available for oral
administration in strengths ... | custom-source | 2025-02-12T13:49:14.968971 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685slr046,047_crixivan_lbl.pdf', 'application_number': 20685, 'submission_type': 'SUPPL ', 'submission_number': 46} |
13,194 |
4
CRIXIVAN®
(INDINAVIR SULFATE)
CAPSULES
DESCRIPTION
CRIXIVAN* (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV)
protease. CRIXIVAN Capsules are formulated as a sulfate salt and are available for oral
administration in strengths of 100, 200, 333, and 400 mg of indinavir (correspo... | custom-source | 2025-02-12T13:49:15.117964 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685s060lbl.pdf', 'application_number': 20685, 'submission_type': 'SUPPL ', 'submission_number': 60} |
13,193 |
CRIXIVAN®
(INDINAVIR SULFATE)
CAPSULES
DESCRIPTION
CRIXIVAN* (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease. CRIXIVAN
Capsules are formulated as a sulfate salt and are available for oral administration in strengths of 100, 200, 333, and
400 mg of indinavir (corresp... | custom-source | 2025-02-12T13:49:15.214517 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s55lbl.pdf', 'application_number': 20685, 'submission_type': 'SUPPL ', 'submission_number': 55} |
13,195 |
CRIXIVAN® (indinavir sulfate) Capsules
CRIXIVAN®
(INDINAVIR SULFATE)
CAPSULES
DESCRIPTION
CRIXIVAN* (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease.
CRIXIVAN Capsules are formulated as a sulfate salt and are available for oral administration in strengths
of 100,... | custom-source | 2025-02-12T13:49:15.337206 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s061lbl.pdf', 'application_number': 20685, 'submission_type': 'SUPPL ', 'submission_number': 61} |
13,196 |
CRIXIVAN®
(INDINAVIR SULFATE)
CAPSULES
DESCRIPTION
CRIXIVAN* (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease.
CRIXIVAN Capsules are formulated as a sulfate salt and are available for oral administration in strengths
of 100, 200, 333, and 400 mg of indinavir (correspo... | custom-source | 2025-02-12T13:49:15.476095 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s062lbl.pdf', 'application_number': 20685, 'submission_type': 'SUPPL ', 'submission_number': 62} |
13,197 |
Enclosure: approved labeling (package insert and patient package insert)
CRIXIVAN®
(INDINAVIR SULFATE)
CAPSULES
DESCRIPTION
CRIXIVAN* (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease.
CRIXIVAN Capsules are formulated as a sulfate salt and are available for oral admi... | custom-source | 2025-02-12T13:49:15.749898 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s063lbl.pdf', 'application_number': 20685, 'submission_type': 'SUPPL ', 'submission_number': 63} |
13,198 |
Enclosure: approved labeling (package insert and patient package insert)
CRIXIVAN®
(INDINAVIR SULFATE)
CAPSULES
DESCRIPTION
CRIXIVAN* (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease.
CRIXIVAN Capsules are formulated as a sulfate salt and are available for oral admini... | custom-source | 2025-02-12T13:49:15.776518 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020685s064lbl.pdf', 'application_number': 20685, 'submission_type': 'SUPPL ', 'submission_number': 64} |
13,199 |
96406XX
CRIXIVAN®
(INDINAVIR SULFATE)
CAPSULES
DESCRIPTION
CRIXIVAN* (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease.
CRIXIVA... | custom-source | 2025-02-12T13:49:16.047865 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020685s066lbl.pdf', 'application_number': 20685, 'submission_type': 'SUPPL ', 'submission_number': 66} |
13,200 |
Company logo
XXXXXXX
CRIXIVAN®
(INDINAVIR SULFATE)
CAPSULES
DESCRIPTION
CRIXIVAN* (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease.
CRIXIVAN Capsules are formulated as a sulfate salt and are... | custom-source | 2025-02-12T13:49:16.205775 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020685s069lbl.pdf', 'application_number': 20685, 'submission_type': 'SUPPL ', 'submission_number': 69} |
13,202 |
Merck & Co., Inc.
XXXXXXX
CRIXIVAN®
(INDINAVIR SULFATE)
CAPSULES
DESCRIPTION
CRIXIVAN* (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease.
CRIXIVAN Capsules are formulated as a sulfate sa... | custom-source | 2025-02-12T13:49:16.453796 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020685s073lbl.pdf', 'application_number': 20685, 'submission_type': 'SUPPL ', 'submission_number': 73} |
13,201 |
Company logo
XXXXXXX
CRIXIVAN®
(INDINAVIR SULFATE)
CAPSULES
DESCRIPTION
CRIXIVAN* (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease.
CRIXIVAN Capsules are formulated as a sulfate salt ... | custom-source | 2025-02-12T13:49:16.518453 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020685s071lbl.pdf', 'application_number': 20685, 'submission_type': 'SUPPL ', 'submission_number': 71} |
13,203 |
company logo
96406XX
CRIXIVAN®
(INDINAVIR SULFATE)
CAPSULES
DESCRIPTION
CRIXIVAN* (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease.
CRIXIVAN Capsules are formulated as a sulfate sal... | custom-source | 2025-02-12T13:49:16.690659 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020685s075lbl.pdf', 'application_number': 20685, 'submission_type': 'SUPPL ', 'submission_number': 75} |
13,205 | MIFEPREX™ (mifepristone) Tablets, 200 mg
For Oral Administration Only
If Mifeprex* results in incomplete abortion, surgical intervention may be necessary.
Prescribers should determine in advance whether they will provide such care themselves
or through other providers. Prescribers should also give patients clear instr... | custom-source | 2025-02-12T13:49:16.996915 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20687lbl.pdf', 'application_number': 20687, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,204 |
1
CRIXIVAN®
(INDINAVIR SULFATE)
CAPSULES
DESCRIPTION
CRIXIVAN® (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease.
CRIXIVAN Capsules are formulated as a sulfate salt and are available for oral administration in strengths
of 200 and 400 mg of indinavir (corresponding ... | custom-source | 2025-02-12T13:49:17.060260 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020685s077lbl.pdf', 'application_number': 20685, 'submission_type': 'SUPPL ', 'submission_number': 77} |
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