id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
13,522 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SINGULAIR safely and effectively. See full prescribing information
for SINGULAIR.
SINGULAIR® (montelukast sodium) Tablets, Chewable Tablets,
and Oral Granules
Initial U.S. Approval: 1998
-------------------... | custom-source | 2025-02-12T13:50:19.217372 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020829s065,020830s066,021409s042lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 65} |
13,521 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SINGULAIR safely and effectively. See full prescribing information
for SINGULAIR.
SINGULAIR
® (monte... | custom-source | 2025-02-12T13:50:19.239306 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829S63-20830S64-21409S40lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 63} |
13,524 | custom-source | 2025-02-12T13:50:19.388805 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20830S008_Singulair_prntlbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 8} | |
13,525 | NDA 20-788/S-003
Page 3
PROPECIA
(Finasteride)
Tablets, 1 mg
DESCRIPTION
PROPECIA* (finasteride), a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II
5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT).
Finasteride is 4-azaandrost-1-... | custom-source | 2025-02-12T13:50:19.635309 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20788s3lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 11} |
13,523 |
... | custom-source | 2025-02-12T13:50:19.724844 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021409s043lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 66} |
13,526 | 1
9088815
SINGULAIR®
(MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
DESCRIPTION
Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene
receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.
Montelukast
sodium
is
described
chemic... | custom-source | 2025-02-12T13:50:19.729320 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20829se1-017_singulair_lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 20} |
13,528 | Patient Information
SINGULAIR® (SING-u-lair) Tablets, Chewable Tablets, and Oral Granules
Generic name: montelukast (mon-te-LOO-kast) sodium
Read this information before you start taking
SINGULAIR®. Also, read the leaflet you get each time
you refill SINGULAIR, since there may be new
information in the leaflet since th... | custom-source | 2025-02-12T13:50:19.910410 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s031,20830s033,21409s010lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 33} |
13,529 |
9088823
1
SINGULAIR®
(MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
DESCRIPTION
Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene
receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.
Montelukast
sodium
is
des... | custom-source | 2025-02-12T13:50:20.130074 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s033,020830s035,021409s012lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 35} |
13,530 |
XXXXXXX
1
V09/14/2005
SINGULAIR®
(MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
DESCRIPTION
Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene
receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.
Montelukast
sodi... | custom-source | 2025-02-12T13:50:20.165091 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s034,020830s036,021409s014lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 36} |
13,527 | Sample
Not For Sale
No. 3761
LOT
X0000
EXP
XXX00
Sample—Not For Sale • SRN 6886
10
Patient
Packs,
4 Tablets
Each
F.P.O.
9364602 | custom-source | 2025-02-12T13:50:20.277097 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr025,20830slr028_singulair_lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 28} |
13,533 |
90888XX
1
SINGULAIR®
(MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
DESCRIPTION
Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene
receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.
Montelukast
sodium
is
descr... | custom-source | 2025-02-12T13:50:20.918659 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s38,020830s40,021409s018lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 40} |
13,534 |
M
erck & Co., Inc. Logo and Address
SINGULAIR®
(MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
DESCRIPTION
Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene
receptor antago... | custom-source | 2025-02-12T13:50:21.083493 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s047,020830s049,021409s025lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 49} |
13,532 |
908882X
1
SINGULAIR®
(MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
DESCRIPTION
Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene
receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.
Montelukast
sodium
is
des... | custom-source | 2025-02-12T13:50:21.199031 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s037,020830s039,021409s017lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 39} |
13,531 |
9628408
1
SINGULAIR®
(MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
DESCRIPTION
Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene
receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.
Montelukast
sodium
is
descr... | custom-source | 2025-02-12T13:50:21.214235 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020829s036,020830s038,021409s016lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 38} |
13,538 | Reference ID: 3205312
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Reference ID: 3205312
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Reference ID... | custom-source | 2025-02-12T13:50:21.573701 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s061,020830s063,021409s039lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 63} |
13,535 | Merck Sharp & Dohme Corp., a subsidiary of
o MERCK & CO., INC.
Whitehouse Station, NJ 08889/ USA
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SINGULAIR safely and effectively. See full prescribing information
for SINGULAIR.
SINGULAIRiI
(montelukast sodiu... | custom-source | 2025-02-12T13:50:21.937110 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s055,020830s056,021409s031lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 56} |
13,537 |
company logo
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SINGULAIR safely and effectively. See full prescribing information
for SINGULAIR.
SINGUL... | custom-source | 2025-02-12T13:50:21.969512 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s060,020830s062,021409s037lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 62} |
13,536 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SINGULAIR safely and effectively. See full prescribing information
for SINGULAIR.
SINGULAIR
® (monteluka... | custom-source | 2025-02-12T13:50:22.121410 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020830s061lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 61} |
13,539 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SINGULAIR safely and effectively. See full prescribing information
for SINGULAIR.
SINGULAIR
® (monte... | custom-source | 2025-02-12T13:50:22.309626 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829S63-20830S64-21409S40lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 64} |
13,542 | custom-source | 2025-02-12T13:50:22.692769 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20831_Foradil_prntlbl.pdf', 'application_number': 20831, 'submission_type': 'ORIG ', 'submission_number': 1} | |
13,540 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SINGULAIR safely and effectively. See full prescribing information
for SINGULAIR.
SINGULAIR® (montelukast sodium) Tablets, Chewable Tablets,
and Oral Granules
Initial U.S. Approval: 1998
-------------------... | custom-source | 2025-02-12T13:50:22.834933 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020829s065,020830s066,021409s042lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 66} |
13,541 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SINGULAIR safely and effectively. See full prescribing information
for SINGULAIR.
SINGULAIR® (montelukast sodium) Tablets, Chewable Tablets,
and Oral Granules
Initial U.S. Approval: 1998
-------------------... | custom-source | 2025-02-12T13:50:23.063081 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045lbl.pdf', 'application_number': 20830, 'submission_type': 'SUPPL ', 'submission_number': 70} |
13,543 | NDA 20-831/S005
Page 3
xxxxxxxx
FORADIL® AEROLIZER®
(formoterol fumarate inhalation powder)
Rx only
Prescribing Information
DESCRIPTION
FORADIL® AEROLIZER® consists of a capsule dosage form containing a dry powder formulation of
FORADIL (formoterol fumarate) intended for oral inhalation only with the A... | custom-source | 2025-02-12T13:50:23.073104 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20831se5-005_foradil_lbl.pdf', 'application_number': 20831, 'submission_type': 'SUPPL ', 'submission_number': 5} |
13,546 | 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 | 2025-02-12T13:50:23.333288 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020832s008lbl.pdf', 'application_number': 20832, 'submission_type': 'SUPPL ', 'submission_number': 8} |
13,544 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the informatio... | custom-source | 2025-02-12T13:50:23.342049 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020831s027lbl.pdf', 'application_number': 20831, 'submission_type': 'SUPPL ', 'submission_number': 27} |
13,547 | NDA 20-832/S-016
Page 4
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Enturia recommends all users participate in a product in-service training prior to
use. In-servicing is available from your Enturia sales representative.
C... | custom-source | 2025-02-12T13:50:23.485183 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020832s016lbl.pdf', 'application_number': 20832, 'submission_type': 'SUPPL ', 'submission_number': 16} |
13,545 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
FOR... | custom-source | 2025-02-12T13:50:23.670018 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020831s028lbl.pdf', 'application_number': 20831, 'submission_type': 'SUPPL ', 'submission_number': 28} |
13,548 | NDA 20-832/S-018
Page 3
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NDA 20-832/S-018
Page 4
This label may not be the latest approved by FDA.
For current labeling information, please visit https://... | custom-source | 2025-02-12T13:50:23.709855 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020832s018lbl.pdf', 'application_number': 20832, 'submission_type': 'SUPPL ', 'submission_number': 18} |
13,550 | 3
Swabstick Insert - Front
Reference ID: 3388622
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
4
Swabstick Insert – Back
Single
Reference ID: 3388622
This label may not be the latest approved by FDA.
For cur... | custom-source | 2025-02-12T13:50:23.860416 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020832Orig1s031, 021555Orig1s018lbl.pdf', 'application_number': 20832, 'submission_type': 'SUPPL ', 'submission_number': 31} |
13,549 | 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
Reference ID: 3175064
This label may not be the latest app... | custom-source | 2025-02-12T13:50:24.311216 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Origs030, 021555Orig1s017lbl.pdf', 'application_number': 20832, 'submission_type': 'SUPPL ', 'submission_number': 30} |
13,552 | PRODUCT INFORMATION
1
FLOVENT® DISKUS® 50 mcg
2
(fluticasone propionate inhalation powder, 50 mcg)
3
4
FLOVENT® DISKUS® 100 mcg
5
(fluticasone propionate inhalation powder, 100 mcg)
6
7
FLOVENT® DISKUS® 250 mcg
8
(fluticasone propionate inhalation powder, 250 mcg)
9
10
For Oral Inhalation Only
11
12
DESCRIPTION: The ac... | custom-source | 2025-02-12T13:50:24.832874 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20833s012lbl.pdf', 'application_number': 20833, 'submission_type': 'SUPPL ', 'submission_number': 12} |
13,553 | 1
PRESCRIBING INFORMATION
1
FLOVENT® DISKUS® 50 mcg
2
(fluticasone propionate inhalation powder, 50 mcg)
3
4
FLOVENT® DISKUS® 100 mcg
5
(fluticasone propionate inhalation powder, 100 mcg)
6
7
FLOVENT® DISKUS® 250 mcg
8
(fluticasone propionate inhalation powder, 250 mcg)
9
10
For Oral Inhalatio... | custom-source | 2025-02-12T13:50:24.925627 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020833s015lbl.pdf', 'application_number': 20833, 'submission_type': 'SUPPL ', 'submission_number': 15} |
13,551 | 163364
/
231932
/
5116
/
314
/
8732
/
8316
/
314
/
1116
/
2
13964
/
2932
/
22364
/
Artwork No. 6-824449 QXXXX
200 applicators
CareFusion
El Paso, TX 79912
1.800.523.0502
www.chloraprep.com
Made in the USA of US and imported parts
Professional Use Only
Store between 15-30 ºC (59-86 ºF)
Avoid freezing and excessive hea... | custom-source | 2025-02-12T13:50:25.489161 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020832Orig1s034, 021555Orig1s019lbl.pdf', 'application_number': 20832, 'submission_type': 'SUPPL ', 'submission_number': 34} |
13,554 |
... | custom-source | 2025-02-12T13:50:25.748300 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020833s031lbl.pdf', 'application_number': 20833, 'submission_type': 'SUPPL ', 'submission_number': 31} |
13,555 | MEN’S
EXTRA STRENGTH
NEW
LOOK
• One 60 mL (2 fl oz) Bottle of
Men’s ROGAINE® Extra Strength
(one month supply)
• One child-resistant dropper
applicator
• Information booklet with complete
directions on how to use and obtain
best results
THIS PACKAGE CONTAINS
UNSCENTED
Not For Use By Women
Drug Facts
Active ingred... | custom-source | 2025-02-12T13:50:25.820838 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020834Orig1s014lbl.pdf', 'application_number': 20834, 'submission_type': 'SUPPL ', 'submission_number': 14} |
13,556 | 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 | 2025-02-12T13:50:25.850076 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf', 'application_number': 20835, 'submission_type': 'SUPPL ', 'submission_number': 1} |
13,557 | 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 | 2025-02-12T13:50:25.958285 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf', 'application_number': 20835, 'submission_type': 'SUPPL ', 'submission_number': 2} |
13,558 | 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 | 2025-02-12T13:50:26.078320 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf', 'application_number': 20835, 'submission_type': 'SUPPL ', 'submission_number': 4} |
13,560 |
ACTONEL®
(risedronate sodium tablets)
DESCRIPTION
ACTONEL (risedronate sodium tablets) is a pyridinyl bisphosphonate that inhibits osteoclast-mediated
bone resorption and modulates bone metabolism. Each ACTONEL tablet for oral administration
contains the equivalent of 5, 30, or 35 mg of anhydrous risedronat... | custom-source | 2025-02-12T13:50:26.197393 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s022s023lbl.pdf', 'application_number': 20835, 'submission_type': 'SUPPL ', 'submission_number': 22} |
13,561 |
ACTONEL®
(risedronate sodium tablets)
DESCRIPTION
ACTONEL (risedronate sodium tablets) is a pyridinyl bisphosphonate that inhibits osteoclast-mediated
bone resorption and modulates bone metabolism. Each ACTONEL tablet for oral administration
contains the equivalent of 5, 30, 35, or 75 mg of anhydrous rised... | custom-source | 2025-02-12T13:50:26.337376 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020835s025lbl.pdf', 'application_number': 20835, 'submission_type': 'SUPPL ', 'submission_number': 25} |
13,559 |
ACTONEL®
(risedronate sodium tablets)
DESCRIPTION
ACTONEL (risedronate sodium tablets) is a pyridinyl bisphosphonate that inhibits osteoclast-mediated
bone resorption and modulates bone metabolism. Each ACTONEL tablet for oral administration
contains the equivalent of 5, 30, or 35 mg of anhydrous risedronat... | custom-source | 2025-02-12T13:50:26.424767 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20835slr014_actionel_lbl.pdf', 'application_number': 20835, 'submission_type': 'SUPPL ', 'submission_number': 14} |
13,563 |
____________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:50:26.614173 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020835s035lbl.pdf', 'application_number': 20835, 'submission_type': 'SUPPL ', 'submission_number': 35} |
13,562 | Actonel (risedronate sodium) Tablet, Film Coated
[Procter & Gamble Pharmaceuticals, Inc.]
DESCRIPTION
ACTONEL (risedronate sodium tablets) is a pyridinyl bisphosphonate that inhibits osteoclast-
mediated bone resorption and modulates bone metabolism. Each ACTONEL tablet for oral
administration contains the equival... | custom-source | 2025-02-12T13:50:26.780206 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020835s028lbl.pdf', 'application_number': 20835, 'submission_type': 'SUPPL ', 'submission_number': 28} |
13,564 |
____________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:50:26.953857 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020835s036lbl.pdf', 'application_number': 20835, 'submission_type': 'SUPPL ', 'submission_number': 36} |
13,565 | HIGHLIGHTS OF PRESCRIBING INFORMATION
• Known hypersensitivity to any component of this product (4, 6.2)
These highlights do not include all the information needed to use Actonel
-----------------------WARNINGS AND PRECAUTIONS------------------------
safely and effectively. See Full Prescribing Information for Acto... | custom-source | 2025-02-12T13:50:27.185574 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020835s042s043lbl.pdf', 'application_number': 20835, 'submission_type': 'SUPPL ', 'submission_number': 43} |
13,566 |
____________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:50:27.342751 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020835s045lbl.pdf', 'application_number': 20835, 'submission_type': 'SUPPL ', 'submission_number': 45} |
13,568 | NDA 20-837
Page 4
Xopenex™ (levalbuterol HCl) Inhalation Solution*, 0.63 mg, 1.25 mg
*Potency expressed as levalbuterol
PRESCRIBING INFORMATION
DESCRIPTION:
Xopenex (levalbuterol HCl) Inhalation Solution is a sterile, clear, colorless, preservative-free
solution of the hydrochloride salt of levalbuterol, the (R)-enanti... | custom-source | 2025-02-12T13:50:27.629710 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20837lbl.pdf', 'application_number': 20837, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,567 |
... | custom-source | 2025-02-12T13:50:27.645833 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s047lbl.pdf', 'application_number': 20835, 'submission_type': 'SUPPL ', 'submission_number': 47} |
13,569 | Xopenex® (levalbuterol HCl) Inhalation Solution, 0.31 mg*, 0.63 mg*,
1
1.25 mg*
2
3
4
*Potency expressed as levalbuterol
5
6
7
PRESCRIBING INFORMATION
8
DESCRIPTION:
9
Xopenex (levalbuterol HCl) Inhalation Solution is a sterile, clear, colorless, preservative-free
10
solution of the hydrochloride salt of levalbuterol, ... | custom-source | 2025-02-12T13:50:27.735676 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20837S6lbl.pdf', 'application_number': 20837, 'submission_type': 'SUPPL ', 'submission_number': 6} |
13,573 | NDA 20-838/S-022
Page 3
Rev 05/05
ATACAND®
(candesartan cilexetil)
TABLETS
USE IN PREGNANCY-
When used in pregnancy during the second and third trimesters, drugs that act directly on the
renin-angiotensin system can cause injury and even death to the developing fetus. When
pregnancy is detected, ATACA... | custom-source | 2025-02-12T13:50:28.112211 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020838s022lbl.pdf', 'application_number': 20838, 'submission_type': 'SUPPL ', 'submission_number': 22} |
13,571 |
... | custom-source | 2025-02-12T13:50:28.399173 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020837s041lbl.pdf', 'application_number': 20837, 'submission_type': 'SUPPL ', 'submission_number': 41} |
13,572 | *Potency expressed as levalbuterol
Xopenex is a registered trademark of Sunovion
Pharmaceuticals Inc. and is used under license.
XPCAP Rev. 12/14
Keep out of reach of children. Rx Only.
NDC 17478-171-01
Open Foil Pouch Just
Prior to Administration
Dilute Before Use
(levalbuterol HCl)
Inhalation Solution
Concentrat... | custom-source | 2025-02-12T13:50:28.400872 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020837s043lbledt.pdf', 'application_number': 20837, 'submission_type': 'SUPPL ', 'submission_number': 43} |
13,570 |
s
t
ruct
u
ral
form
ula
Xopenex® (levalbuterol HCl) Inhalation Solution Concentrate, 1.25 mg*
*Potency expressed as levalbuterol
PRESCRIBING INFORMATION
DESCRIPTION:
Xopenex (levalbuterol HCl) Inhalation Solution is a sterile, clear, colorless, preservative-free ... | custom-source | 2025-02-12T13:50:28.473741 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020837s036lbl.pdf', 'application_number': 20837, 'submission_type': 'SUPPL ', 'submission_number': 36} |
13,574 | NDA 20-838/S-024
Page 3
Rev 02/05
ATACAND
(candesartan cilexetil)
TABLETS
USE IN PREGNANCY-
When used in pregnancy during the second and third trimesters, drugs that act directly on the
renin-angiotensin system can cause injury and even death to the developing fetus. When
pregnancy is detected, ATACA... | custom-source | 2025-02-12T13:50:28.741926 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20838s024lbl.pdf', 'application_number': 20838, 'submission_type': 'SUPPL ', 'submission_number': 24} |
13,576 |
... | custom-source | 2025-02-12T13:50:29.006586 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020838s036lbl.pdf', 'application_number': 20838, 'submission_type': 'SUPPL ', 'submission_number': 36} |
13,577 |
... | custom-source | 2025-02-12T13:50:29.021552 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020838s039lbl.pdf', 'application_number': 20838, 'submission_type': 'SUPPL ', 'submission_number': 39} |
13,575 |
_______________________________________________________________________... | custom-source | 2025-02-12T13:50:29.153549 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020838s032lbl.pdf', 'application_number': 20838, 'submission_type': 'SUPPL ', 'submission_number': 32} |
13,579 | NDA 20-839/S-030/S-031
Page 4
Rx only
Plavix
clopidogrel bisulfate tablets
DESCRIPTION
PLAVIX (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct
inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADP-
mediated activation of the glyc... | custom-source | 2025-02-12T13:50:29.224240 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s030,031lbl.pdf', 'application_number': 20839, 'submission_type': 'SUPPL ', 'submission_number': 30} |
13,580 | NDA 20-839/S-030/S-031
Page 4
Rx only
Plavix
clopidogrel bisulfate tablets
DESCRIPTION
PLAVIX (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct
inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADP-
mediated activation of the glyc... | custom-source | 2025-02-12T13:50:29.425627 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s030,031lbl.pdf', 'application_number': 20839, 'submission_type': 'SUPPL ', 'submission_number': 31} |
13,581 | NDA 20-839/S-033
Page 4
Rx only
Plavix
clopidogrel bisulfate tablets
DESCRIPTION
Plavix (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct
inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADP-
mediated activation of the glyc... | custom-source | 2025-02-12T13:50:29.511552 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s033lbl.pdf', 'application_number': 20839, 'submission_type': 'SUPPL ', 'submission_number': 33} |
13,582 | NDA 20-839/S-035
Page 5
Rx only
PLAVIX®
clopidogrel bisulfate tablets
DESCRIPTION
Plavix (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct inhibition of
adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADP-mediated activation of the
glyco... | custom-source | 2025-02-12T13:50:29.569320 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020839s035lbl.pdf', 'application_number': 20839, 'submission_type': 'SUPPL ', 'submission_number': 35} |
13,583 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to us... | custom-source | 2025-02-12T13:50:29.778664 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020839s042lbl.pdf', 'application_number': 20839, 'submission_type': 'SUPPL ', 'submission_number': 42} |
13,584 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
PL... | custom-source | 2025-02-12T13:50:30.011416 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020839s057lbl.pdf', 'application_number': 20839, 'submission_type': 'SUPPL ', 'submission_number': 57} |
13,587 | 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 | 2025-02-12T13:50:30.157965 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20841lbl.pdf', 'application_number': 20841, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,585 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information ne... | custom-source | 2025-02-12T13:50:30.163132 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020839s058lbl.pdf', 'application_number': 20839, 'submission_type': 'SUPPL ', 'submission_number': 58} |
13,586 |
... | custom-source | 2025-02-12T13:50:30.301018 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020839s061_lbl.pdf', 'application_number': 20839, 'submission_type': 'SUPPL ', 'submission_number': 61} |
13,588 | NDA 19-781/S-005, 006
20-843/S-005, 006
Page 3
500032 Rev Dec 2004
PROMETRIUM®
(progesterone, USP)
Capsules 100 mg
Capsules 200 mg
WARNINGS
Progestins and estrogens should not be used for the prevention of cardiovascular disease. (See
WARNINGS, Cardiovascular Disorders.)
The Women's H... | custom-source | 2025-02-12T13:50:30.529349 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19781s005,006,20843s005,006lbl.pdf', 'application_number': 20843, 'submission_type': 'SUPPL ', 'submission_number': 5} |
13,589 | NDA 19-781/S-005, 006
20-843/S-005, 006
Page 3
500032 Rev Dec 2004
PROMETRIUM®
(progesterone, USP)
Capsules 100 mg
Capsules 200 mg
WARNINGS
Progestins and estrogens should not be used for the prevention of cardiovascular disease. (See
WARNINGS, Cardiovascular Disorders.)
The Women's H... | custom-source | 2025-02-12T13:50:30.656438 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19781s005,006,20843s005,006lbl.pdf', 'application_number': 20843, 'submission_type': 'SUPPL ', 'submission_number': 6} |
13,590 | NDA 20-844/ Topamav Sprinkle Capsules
Version: 10/26/98
Approved Labeling Text
DESCRIPTION
Topiramate is a sulfamate-substituted monosaccharide that is intended for use as an antiepileptic drug.
TOPAMAX@ (topiramate capsules) Sprinkle Capsules are available as I5 mg, 25 mg and 50mg
sprinkle capsules for oral administra... | custom-source | 2025-02-12T13:50:30.751942 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20844lbl.pdf', 'application_number': 20844, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,591 | custom-source | 2025-02-12T13:50:30.803013 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20844S1_Topamax_appltr_prntlbl.pdf', 'application_number': 20844, 'submission_type': 'SUPPL ', 'submission_number': 1} | |
13,592 | NDA 20-505 S-010, S-017, S-019
NDA 20-844 S-006, S-014, S-016
Approved Labeling Text dated 12/16/03
1
TOPAMAX
(topiramate)
Tablets
TOPAMAX
(topiramate capsules)
Sprinkle Capsules
DESCRIPTION
Topiramate is a sulfamate-substituted monosaccharide that is... | custom-source | 2025-02-12T13:50:30.909406 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf', 'application_number': 20844, 'submission_type': 'SUPPL ', 'submission_number': 6} |
13,593 | NDA 20-505 S-010, S-017, S-019
NDA 20-844 S-006, S-014, S-016
Approved Labeling Text dated 12/16/03
1
TOPAMAX
(topiramate)
Tablets
TOPAMAX
(topiramate capsules)
Sprinkle Capsules
DESCRIPTION
Topiramate is a sulfamate-substituted monosaccharide that is... | custom-source | 2025-02-12T13:50:30.996899 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf', 'application_number': 20844, 'submission_type': 'SUPPL ', 'submission_number': 14} |
13,595 | NDA 20-505/S-022 & NDA 20-844/S-019
FDA Draft Labeling Text dated 08/10/04
1
TOPAMAX
(topiramate)
Tablets
TOPAMAX
(topiramate capsules)
Sprinkle Capsules
DESCRIPTION
Topiramate is a sulfamate-substituted monosaccharide. TOPAMAX (topiramate)
Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg... | custom-source | 2025-02-12T13:50:31.161570 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20505s022,025,20844s019,021lbl.pdf', 'application_number': 20844, 'submission_type': 'SUPPL ', 'submission_number': 19} |
13,594 | NDA 20-505/S-018/S-026 & NDA 20-844/S-015/S-022
FDA Approved Labeling Text dated 6/29/05
1
TOPAMAX
(topiramate)
Tablets
TOPAMAX
(topiramate capsules)
Sprinkle Capsules
DESCRIPTION
Topiramate is a sulfamate-substituted monosaccharide. TOPAMAX (topiramate)
Tablets are available as 25 mg, 50 mg, 100 m... | custom-source | 2025-02-12T13:50:31.324753 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020844s015S022lbl.pdf', 'application_number': 20844, 'submission_type': 'SUPPL ', 'submission_number': 15} |
13,596 | NDA 20-505/S-018/S-026 & NDA 20-844/S-015/S-022
FDA Approved Labeling Text dated 6/29/05
1
TOPAMAX
(topiramate)
Tablets
TOPAMAX
(topiramate capsules)
Sprinkle Capsules
DESCRIPTION
Topiramate is a sulfamate-substituted monosaccharide. TOPAMAX (topiramate)
Tablets are available as 25 mg, 50 mg, 100 m... | custom-source | 2025-02-12T13:50:31.563471 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020844s015S022lbl.pdf', 'application_number': 20844, 'submission_type': 'SUPPL ', 'submission_number': 22} |
13,597 |
C
he
mi
ca
l
St
ruc
ture
TOPAMAX®
(topiramate)
Tablets
TOPAMAX®
(topiramate capsules)
Sprinkle Capsules
Rx only
DESCRIPTION
Topiramate is a sulfamate-substituted monosaccharide. TOPAMAX® (topiramate)
Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral
admi... | custom-source | 2025-02-12T13:50:32.694234 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s036,020844s030lbl.pdf', 'application_number': 20844, 'submission_type': 'SUPPL ', 'submission_number': 30} |
13,599 |
M
ol
ec
ul
ar
s
tru
ctur
e of Topira
mate
TOPAMAX®
(topiramate)
Tablets
TOPAMAX®
(topiramate capsules)
Sprinkle Capsules
Rx only
DESCRIPTION
Topiramate is a sulfamate-substituted monosaccharide. TOPAMAX® (topiramate)
Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets... | custom-source | 2025-02-12T13:50:32.813484 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s034lbl.pdf', 'application_number': 20844, 'submission_type': 'SUPPL ', 'submission_number': 32} |
13,598 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do no... | custom-source | 2025-02-12T13:50:33.607279 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf', 'application_number': 20844, 'submission_type': 'SUPPL ', 'submission_number': 31} |
13,600 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include a... | custom-source | 2025-02-12T13:50:34.000292 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037lbl.pdf', 'application_number': 20844, 'submission_type': 'SUPPL ', 'submission_number': 35} |
13,601 |
NDA 020505/S-042 & NDA 020844/S-036
FDA Approved Labeling Text dated July 15, 2011
HIGHLIGHTS OF PRESCRIBING INFO... | custom-source | 2025-02-12T13:50:34.538161 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s042,020844s036lbl.pdf', 'application_number': 20844, 'submission_type': 'SUPPL ', 'submission_number': 36} |
13,603 |
... | custom-source | 2025-02-12T13:50:35.019732 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s053,020844s044lbl.pdf', 'application_number': 20844, 'submission_type': 'SUPPL ', 'submission_number': 44} |
13,604 |
... | custom-source | 2025-02-12T13:50:35.583009 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s054,020844s045lbl.pdf', 'application_number': 20844, 'submission_type': 'SUPPL ', 'submission_number': 45} |
13,607 |
_________________
_______________
______________
_____________
... | custom-source | 2025-02-12T13:50:35.791151 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020845s009lbl.pdf', 'application_number': 20845, 'submission_type': 'SUPPL ', 'submission_number': 9} |
13,602 |
... | custom-source | 2025-02-12T13:50:35.917601 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s052,020844s043lbl.pdf', 'application_number': 20844, 'submission_type': 'SUPPL ', 'submission_number': 43} |
13,609 |
----------
... | custom-source | 2025-02-12T13:50:36.301895 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020845s014lbl.pdf', 'application_number': 20845, 'submission_type': 'SUPPL ', 'submission_number': 14} |
13,605 |
... | custom-source | 2025-02-12T13:50:36.368711 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s055,020844s046lbl.pdf', 'application_number': 20844, 'submission_type': 'SUPPL ', 'submission_number': 46} |
13,608 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use INOmax
safely and effectively. See full prescribing information for INOmax.
INOmax (nitric oxide) for inhalation
Initial U.S. Approval: 1999
_________________ INDICATIONS AND USAGE__________________
IN... | custom-source | 2025-02-12T13:50:36.425035 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020845s011lbl.pdf', 'application_number': 20845, 'submission_type': 'SUPPL ', 'submission_number': 11} |
13,610 |
... | custom-source | 2025-02-12T13:50:36.505431 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020845s016s017lbl.pdf', 'application_number': 20845, 'submission_type': 'SUPPL ', 'submission_number': 17} |
13,612 | F7-19-01-597
1
20% ProSol™ - sulfite-free (Amino Acid) Injection
Pharmacy Bulk Package
Not for Direct Infusion
in Viaflex® Plastic Container
Description
20% ProSol™ - sulfite-free (Amino Acid) Injection is a sterile, nonpyrogenic, hypertonic
solution of essential and nonessential amino acids provided in a Pharmacy Bulk... | custom-source | 2025-02-12T13:50:36.609383 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20849lbl.pdf', 'application_number': 20849, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,611 | 1
LAMISIL®
(terbinafine)
DermGel
, 1%
equivalent to 1.12%
terbinafine hydrochloride
FOR TOPICAL DERMATOLOGIC USE ONLY - - NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE.
DESCRIPTION
Lamisil® (terbinafine) DermGel™, 1% contains the synthetic antifungal
compound, terbinafine. It is intended for topical dermatologic use... | custom-source | 2025-02-12T13:50:36.734173 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20846s001lbl.pdf', 'application_number': 20846, 'submission_type': 'SUPPL ', 'submission_number': 1} |
13,613 | NDA 20-850/S-013
Page 3
Micardis®
(telmisartan)
Tablets, 20 mg, 40 mg and 80 mg
Prescribing Information
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on the
renin-angiotensin system can cause injury and even death to the developing f... | custom-source | 2025-02-12T13:50:36.813564 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020850s013lbl.pdf', 'application_number': 20850, 'submission_type': 'SUPPL ', 'submission_number': 13} |
13,614 |
NDA 20-850/S-022/S-023
Page 3
Micardis
(telmisartan)
Tablets, 20 mg, 40 mg and 80 mg
Rx only
Prescribing Information Boehringer Ingelheim
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on
the renin-angiotensin... | custom-source | 2025-02-12T13:50:36.877509 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s022s023lbl.pdf', 'application_number': 20850, 'submission_type': 'SUPPL ', 'submission_number': 22} |
13,615 |
NDA 20-850/S-022/S-023
Page 3
Micardis
(telmisartan)
Tablets, 20 mg, 40 mg and 80 mg
Rx only
Prescribing Information Boehringer Ingelheim
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on
the renin-angiotensin... | custom-source | 2025-02-12T13:50:36.929472 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s022s023lbl.pdf', 'application_number': 20850, 'submission_type': 'SUPPL ', 'submission_number': 23} |
13,617 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:50:37.204815 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s035lbl.pdf', 'application_number': 20850, 'submission_type': 'SUPPL ', 'submission_number': 35} |
13,619 | custom-source | 2025-02-12T13:50:37.302833 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-855_Mesnex_Prntlbl.pdf', 'application_number': 20855, 'submission_type': 'ORIG ', 'submission_number': 1} | |
13,616 |
_______________________________________________________________________________________________________________________________________ ... | custom-source | 2025-02-12T13:50:37.327443 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s025lbl.pdf', 'application_number': 20850, 'submission_type': 'SUPPL ', 'submission_number': 25} |
13,618 |
... | custom-source | 2025-02-12T13:50:37.487899 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s036lbl.pdf', 'application_number': 20850, 'submission_type': 'SUPPL ', 'submission_number': 36} |
13,620 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
MESNEX safely and effectively. See full prescribing information for
MESNEX.
MESNEX (mesna) tablets, for oral use
MESNEX (mesna) injection, for intravenous use
Initial U.S. Approval: 1988
--------------... | custom-source | 2025-02-12T13:50:37.678555 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020855s002lbl.pdf', 'application_number': 20855, 'submission_type': 'SUPPL ', 'submission_number': 2} |
13,621 | NDA 20-857/S-009,010
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 HIV DISEA... | custom-source | 2025-02-12T13:50:37.802585 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20857slr012lbl.pdf', 'application_number': 20857, 'submission_type': 'SUPPL ', 'submission_number': 9} |
13,622 | PRESCRIBING INFORMATION
1
2
3
4
5
COMBIVIR®
(lamivudine/zidovudine)
Tablets
WARNING
6
ZIDOVUDINE, ONE OF THE TWO ACTIVE INGREDIENTS IN COMBIVIR, HAS
7
BEEN ASSOCIATED WITH HEMATOLOGIC TOXICITY INCLUDING
8
NEUTROPENIA AND SEVERE ANEMIA, PARTICULARLY IN PATIENTS WITH
9
ADVANCED HUMAN IMMUNODEFICIENCY... | custom-source | 2025-02-12T13:50:37.900522 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020857s018lbl.pdf', 'application_number': 20857, 'submission_type': 'SUPPL ', 'submission_number': 18} |
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