id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
12,480 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
FAMVIR® safely and effectively. See full ... | custom-source | 2025-02-12T13:47:32.312636 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020363s038s040lbl.pdf', 'application_number': 20363, 'submission_type': 'SUPPL ', 'submission_number': 38} |
12,482 | 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 | 2025-02-12T13:47:32.332898 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020364-S016_Lotrel_lbl.pdf', 'application_number': 20364, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,481 |
... | custom-source | 2025-02-12T13:47:32.352628 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020363s042lbl.pdf', 'application_number': 20363, 'submission_type': 'SUPPL ', 'submission_number': 42} |
12,483 | NDA 20-364/S-023
Page 3
Lotrel®
(amlodipine besylate and benazepril hydrochloride)
Combination Capsules
2.5 mg/10 mg
5 mg/10 mg
5 mg/20 mg
5 mg/40 mg
10 mg/20 mg
10 mg/40 mg
Rx only
Prescribing Information
USE IN PREGNANCY
When used in pregnancy during the second and third trimest... | custom-source | 2025-02-12T13:47:32.409439 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020364s023lbl.pdf', 'application_number': 20364, 'submission_type': 'SUPPL ', 'submission_number': 23} |
12,484 | NDA 20-364/S-024
Page 3
Patient Summary of Information
T2004-25
89022101
LOTREL®‚ (low-TREL)
amlodipine besylate/benazepril hydrochloride capsules
2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 10 mg/20 mg
Rx only
Read this Patient Information leaflet before you start taking LOTREL and each time you get a
refill.... | custom-source | 2025-02-12T13:47:32.667466 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20364slr024_lotrel_lbl.pdf', 'application_number': 20364, 'submission_type': 'SUPPL ', 'submission_number': 24} |
12,485 | NDA 20-364/S-039
Page 2
T2006-113
Lotrel®
(amlodipine besylate and benazepril hydrochloride)
Combination Capsules
2.5 mg/10 mg
5 mg/10 mg
5 mg/20 mg
5 mg/40 mg
10 mg/20 mg
10 mg/40 mg
Rx only
Prescribing Information
USE IN PREGNANCY
When used in pregnancy, ACE inhibitors can ca... | custom-source | 2025-02-12T13:47:32.764432 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020364s039lbl.pdf', 'application_number': 20364, 'submission_type': 'SUPPL ', 'submission_number': 39} |
12,486 |
NDA 20-364/S046
Page 3 logo
T2006-27Lotrel®
(amlodipine besylate and benazepril hydrochloride)
Combination Capsules
2.5 mg/10 mg
5 mg/10 mg
5 mg/20 mg
5 mg/40 mg
10 mg/20 mg
10 mg/40 mg
Rx only
Prescribing Information
USE IN PREG... | custom-source | 2025-02-12T13:47:32.833463 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020364s046lbl.pdf', 'application_number': 20364, 'submission_type': 'SUPPL ', 'submission_number': 46} |
12,487 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Lotrel
safely and effecti... | custom-source | 2025-02-12T13:47:32.919605 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020364s050lbl.pdf', 'application_number': 20364, 'submission_type': 'SUPPL ', 'submission_number': 50} |
12,488 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Lotrel
safely and ... | custom-source | 2025-02-12T13:47:33.092241 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020364s054lbl.pdf', 'application_number': 20364, 'submission_type': 'SUPPL ', 'submission_number': 54} |
12,489 |
... | custom-source | 2025-02-12T13:47:33.315752 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020364s056s057lbl.pdf', 'application_number': 20364, 'submission_type': 'SUPPL ', 'submission_number': 57} |
12,491 | NDA 20-367/S-055
Page 3
CEREZYME® (imiglucerase for injection)
200 Units
400 Units
DESCRIPTION
Cerezyme® (imiglucerase for injection) is an analogue of the human enzyme ß-glucocerebrosidase,
produced by recombinant DNA technology. ß-Glucocerebrosidase (ß-D-glucosyl-N-acylsphingosine
glucohydrolase, E.C. 3.... | custom-source | 2025-02-12T13:47:33.400470 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20367slr055_Cerezyme_lbl.pdf', 'application_number': 20367, 'submission_type': 'SUPPL ', 'submission_number': 55} |
12,490 |
--------------
... | custom-source | 2025-02-12T13:47:33.437667 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020364s060lbl.pdf', 'application_number': 20364, 'submission_type': 'SUPPL ', 'submission_number': 60} |
12,492 | 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 | 2025-02-12T13:47:33.447904 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20369lbl.pdf', 'application_number': 20369, 'submission_type': 'ORIG ', 'submission_number': 1} |
12,494 | NDA 20-369/S-009 & S-010
Page 3
CILOXAN
(ciprofloxacin hydrochloride ophthalmic ointment) 0.3% as Base
Sterile Ophthalmic Ointment
DESCRIPTION:
CILOXAN (ciprofloxacin hydrochloride ophthalmic ointment) is a synthetic, sterile, multiple dose,
antimicrobial for topical use. Ciprofloxacin is a fluoroquinol... | custom-source | 2025-02-12T13:47:33.705867 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20369s009,010lbl.pdf', 'application_number': 20369, 'submission_type': 'SUPPL ', 'submission_number': 10} |
12,496 | Distributed by:
Amersham Health
Medi-Physics, Inc.
Arlington Heights, IL 60004
1-800-633-4123 (Toll Free)
Printed in Ireland
MYOVIEW is a trademark of
Amersham plc.
43-N196-OSLO
Revised March 2005
STORAGE
Store the kit in a refrigerator at
2°-8°C (36°-46°F). The kit should
be protected from light.
Store the reconstitu... | custom-source | 2025-02-12T13:47:33.889777 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020372s019lbl.pdf', 'application_number': 20372, 'submission_type': 'SUPPL ', 'submission_number': 19} |
12,493 | NDA 20-369/S-006 & S-007
Page 5
Streptococcus Viridans Group
Gram-Negative:
Haemophilus influenzae
CONTRAINDICATIONS:
A history of hypersensitivity to ciprofloxacin or any other component of the medication is a
contraindication to its use. A history of hypersensitivity to other quinolones may also con... | custom-source | 2025-02-12T13:47:33.909809 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020369s006s007lbl.pdf', 'application_number': 20369, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,495 | MYOVIEW24
N176A
24 Hour Expiration
Kit for the Preparation of Technetium Tc99m Tetrofosmin for Injection
Stabilized with ascorbic acid, sodium hydrosulfite, and parabens
Diagnostic Radiopharmaceutical
For intravenous use only
Rx ONLY
NOT FOR USE IN NEWBORNS (contains preservatives)
CONTAINS SODIUM HYDROSULFITE
D... | custom-source | 2025-02-12T13:47:33.954617 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20372s9lbl.pdf', 'application_number': 20372, 'submission_type': 'SUPPL ', 'submission_number': 9} |
12,497 | custom-source | 2025-02-12T13:47:34.106188 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara_prntlbl.pdf', 'application_number': 20375, 'submission_type': 'SUPPL ', 'submission_number': 9} | |
12,498 | custom-source | 2025-02-12T13:47:34.515624 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994_appltr_prntlbl.pdf', 'application_number': 20375, 'submission_type': 'SUPPL ', 'submission_number': 11} | |
12,499 | Rxonly
PRESCRIBING INFORMATION
FSTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Oose clinical surveillance of all women taking estrogens is imponanL Adequate diagnostic
~ures,
including endometrial sampling when indicated, should be undertaken to rule out
malignancy in all cases of undiagnosed
persistent or recuning... | custom-source | 2025-02-12T13:47:34.597961 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020375S020lbl.pdf', 'application_number': 20375, 'submission_type': 'SUPPL ', 'submission_number': 20} |
12,500 | NDA 20-375/S-022
Page 3
Rx only
PRESCRIBING INFORMATION
Climara® estradiol transdermal system
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures,
including endometrial sampling when indicated, should be... | custom-source | 2025-02-12T13:47:34.639490 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020375s022lbl.pdf', 'application_number': 20375, 'submission_type': 'SUPPL ', 'submission_number': 22} |
12,501 | NDA 20-375/S-023
Page 3
Rx only
PRESCRIBING INFORMATION Menostar® (estradiol transdermal system)
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures,
including endometrial sampling when indicated, should be und... | custom-source | 2025-02-12T13:47:34.714673 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020375s023LBL.pdf', 'application_number': 20375, 'submission_type': 'SUPPL ', 'submission_number': 23} |
12,503 | NDA 20-381/S-020
Page 3
DESCRIPTION
NIASPAN® (niacin extended-release tablets), contain niacin, a B-complex
vitamin and antihyperlipidemic agent. Niacin (nicotinic acid, or 3-
pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water,
with the following structural formula:
... | custom-source | 2025-02-12T13:47:35.502463 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020381s020lbl.pdf', 'application_number': 20381, 'submission_type': 'SUPPL ', 'submission_number': 20} |
12,504 |
DN1937v1-proposed-niaspan-2009-may-01
1 of 30
HIGHLIGHTS OF PRESCRIBING INFORMATI... | custom-source | 2025-02-12T13:47:35.541175 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf', 'application_number': 20381, 'submission_type': 'SUPPL ', 'submission_number': 39} |
12,502 |
Caverject®
alprostadil for injection
For Intracavernosal Use
DESCRIPTION
CAVERJECT Sterile Powder contains alprostadil as the naturally occurring form of
prostaglandin E1 (PGE1) and is designated chemically as ... | custom-source | 2025-02-12T13:47:35.560924 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020379s030lbl.pdf', 'application_number': 20379, 'submission_type': 'SUPPL ', 'submission_number': 30} |
12,505 |
----------
DN2011V1-proposed-niaspan-2009-sep-22
1 of 38
NIASPAN - niacin tablet, film coated, extended release
Abbott Laboratories
HIG... | custom-source | 2025-02-12T13:47:35.602048 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s042lbl.pdf', 'application_number': 20381, 'submission_type': 'SUPPL ', 'submission_number': 42} |
12,507 | NDA 20-386/S-028
Page 3
COZAAR®
(LOSARTAN POTASSIUM 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, COZAAR should be disconti... | custom-source | 2025-02-12T13:47:36.317210 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20386s28lbl.pdf', 'application_number': 20386, 'submission_type': 'SUPPL ', 'submission_number': 28} |
12,508 | NDA 20-386/S-032
Page 3
COZAAR®
(LOSARTAN POTASSIUM 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, COZAAR should be disconti... | custom-source | 2025-02-12T13:47:36.416952 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020386s032lbl.pdf', 'application_number': 20386, 'submission_type': 'SUPPL ', 'submission_number': 32} |
12,506 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlight... | custom-source | 2025-02-12T13:47:36.697581 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s043lbl.pdf', 'application_number': 20381, 'submission_type': 'SUPPL ', 'submission_number': 43} |
12,509 | NDA 20-386/S-039
NDA 20-387/S-035
Page 3
COZAAR®
(LOSARTAN POTASSIUM 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, COZAAR sh... | custom-source | 2025-02-12T13:47:36.900472 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s039,020387s035lbl.pdf', 'application_number': 20386, 'submission_type': 'SUPPL ', 'submission_number': 39} |
12,511 | NDA 20-386/S-045
Page 3
COZAAR®
(LOSARTAN POTASSIUM 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, COZAAR should be disconti... | custom-source | 2025-02-12T13:47:37.259460 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s045lbl.pdf', 'application_number': 20386, 'submission_type': 'SUPPL ', 'submission_number': 45} |
12,510 | NDA 20-386/S-040
NDA 20-387/S-034
Page 3
COZAAR®
(LOSARTAN POTASSIUM 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, COZAAR sh... | custom-source | 2025-02-12T13:47:37.340209 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s040,020387s034lbl.pdf', 'application_number': 20386, 'submission_type': 'SUPPL ', 'submission_number': 40} |
12,512 |
... | custom-source | 2025-02-12T13:47:37.785756 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020386s054lbl.pdf', 'application_number': 20386, 'submission_type': 'SUPPL ', 'submission_number': 54} |
12,513 | COZAAR® (LOSARTAN POTASSIUM TABLETS)
Page 1 of 28
COZAAR®
(LOSARTAN POTASSIUM 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
... | custom-source | 2025-02-12T13:47:37.894673 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020386s058lbl.pdf', 'application_number': 20386, 'submission_type': 'SUPPL ', 'submission_number': 58} |
12,514 | 1
COZAAR
®
(LOSARTAN POTASSIUM TABLETS)
WARNING: FETAL TOXICITY
x
When pregnancy is detected, discontinue COZAAR® as soon as possible.
x
Drugs that act directly on the renin-angiotensin system can cause injury and death to the
developing fetus. See WARNINGS, Fetal Toxicity.
DESCRIPTION
COZAAR (losartan potassium) is... | custom-source | 2025-02-12T13:47:38.094509 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s060lbl.pdf', 'application_number': 20386, 'submission_type': 'SUPPL ', 'submission_number': 60} |
12,515 |
COZAAR
®
(LOSARTAN POTASSIUM TABLETS)
WARNING: FETAL TOXICITY
•
When pregnancy is detected, discontinue COZAAR® as soon as possi... | custom-source | 2025-02-12T13:47:38.235730 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s061lbl.pdf', 'application_number': 20386, 'submission_type': 'SUPPL ', 'submission_number': 61} |
12,516 | NDA 20-387/S-013, 015, & 027
Page 3
HYZAAR® 50-12.5
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100-25
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on the
renin-angiotensin system can cau... | custom-source | 2025-02-12T13:47:38.635898 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-027,slr015_hyzaar_lbl.pdf', 'application_number': 20387, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,517 | NDA 20-387/S-013, 015, & 027
Page 3
HYZAAR® 50-12.5
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100-25
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on the
renin-angiotensin system can cau... | custom-source | 2025-02-12T13:47:38.711957 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-027,slr015_hyzaar_lbl.pdf', 'application_number': 20387, 'submission_type': 'SUPPL ', 'submission_number': 15} |
12,518 | NDA 20-387/S-013, 015, & 027
Page 3
HYZAAR® 50-12.5
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100-25
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on the
renin-angiotensin system can cau... | custom-source | 2025-02-12T13:47:38.764892 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-027,slr015_hyzaar_lbl.pdf', 'application_number': 20387, 'submission_type': 'SUPPL ', 'submission_number': 27} |
12,519 | NDA 20-387/S-033
Page 3
HYZAAR® 50-12.5
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100-25
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE 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 ... | custom-source | 2025-02-12T13:47:38.826289 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020387s033lbl.pdf', 'application_number': 20387, 'submission_type': 'SUPPL ', 'submission_number': 33} |
12,520 | NDA 20-386/S-040
NDA 20-387/S-034
Page 3
COZAAR®
(LOSARTAN POTASSIUM 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, COZAAR sh... | custom-source | 2025-02-12T13:47:39.165222 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s040,020387s034lbl.pdf', 'application_number': 20387, 'submission_type': 'SUPPL ', 'submission_number': 34} |
12,521 | NDA 20-387/S-037
Page 3
HYZAAR® 50-12.5
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100-12.5
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100-25
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs ... | custom-source | 2025-02-12T13:47:39.304176 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020387s037lbl.pdf', 'application_number': 20387, 'submission_type': 'SUPPL ', 'submission_number': 37} |
12,523 |
HYZAAR® 50-12.5
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100-12.5
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100-25
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ... | custom-source | 2025-02-12T13:47:39.396721 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020387s048lbl.pdf', 'application_number': 20387, 'submission_type': 'SUPPL ', 'submission_number': 48} |
12,522 | NDA 20-387/S-041
Page 3
HYZAAR® 50-12.5
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100-12.5
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100-25
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs th... | custom-source | 2025-02-12T13:47:39.553508 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020387s041lbl.pdf', 'application_number': 20387, 'submission_type': 'SUPPL ', 'submission_number': 41} |
12,525 |
Merck logo
9964305
HYZAAR® 50-12.5
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100-12.5
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100-25
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
USE IN PREGNANCY
When used in pregnancy during the second and thi... | custom-source | 2025-02-12T13:47:39.662693 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020387s055lbl.pdf', 'application_number': 20387, 'submission_type': 'SUPPL ', 'submission_number': 55} |
12,524 |
company logo
9964303
HYZAAR® 50-12.5
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100-12.5
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100-25
(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLE... | custom-source | 2025-02-12T13:47:39.758873 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020387s052lbl.pdf', 'application_number': 20387, 'submission_type': 'SUPPL ', 'submission_number': 52} |
12,526 |
Merck logo
HYZAAR® 50/12.5
(LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100/12.5
(LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100/25
(LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS)
USE IN PREGNANCY
When used in pregnancy during the second and... | custom-source | 2025-02-12T13:47:39.870159 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020387s056lbl.pdf', 'application_number': 20387, 'submission_type': 'SUPPL ', 'submission_number': 56} |
12,527 | HYZAAR® 50/12.5(LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE T... Page 1 of 30
HYZAAR® 50/12.5
(LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100/12.5
(LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR® 100/25
(LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS)
USE IN PREGN... | custom-source | 2025-02-12T13:47:39.958320 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020387s057lbl.pdf', 'application_number': 20387, 'submission_type': 'SUPPL ', 'submission_number': 57} |
12,529 | custom-source | 2025-02-12T13:47:39.988642 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-388S008_Navelbine_prntlbl.pdf', 'application_number': 20388, 'submission_type': 'SUPPL ', 'submission_number': 8} | |
12,528 |
HYZAAR
® 50/12.5
(LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR
® 100/12.5
(LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS)
HYZAAR
® 100/25
(LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS)
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue HYZA... | custom-source | 2025-02-12T13:47:40.121737 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020387s059lbledt.pdf', 'application_number': 20387, 'submission_type': 'SUPPL ', 'submission_number': 59} |
12,530 | PRESCRIBING INFORMATION
1
NAVELBINE®
2
(vinorelbine tartrate)
3
Injection
4
5
WARNING
6
NAVELBINE (vinorelbine tartrate) Injection should be administered under the supervision of a
7
physician experienced in the use of cancer chemotherapeutic agents. This product is for intravenous
8
(IV) use only. Intrathecal administ... | custom-source | 2025-02-12T13:47:40.246377 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20388S014lbl.pdf', 'application_number': 20388, 'submission_type': 'SUPPL ', 'submission_number': 14} |
12,532 | Atrovent®
(ipratropium bromide)
Nasal Spray
0.03%
ATTENTION PHARMACIST: Detach “Patient’s Instructions for Use” from package insert and dispense with product.
10001900/US/1
10001900/01
PATIENT’S INSTRUCTIONS FOR USE
ATROVENT® (ipratropium bromide) Nasal Spray
0.03% is indicated for the symptomatic relief of
rhinorrhea... | custom-source | 2025-02-12T13:47:40.405847 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20393slr004,20394slr005_atrovent_lbl.pdf', 'application_number': 20393, 'submission_type': 'SUPPL ', 'submission_number': 4} |
12,531 | NDA 20-392/S-010
Page 3
CYST:RX2P
CYSTAGON®
(cysteamine bitartrate)
Capsules
50 mg and 150 mg
Rx only
DESCRIPTION: CYSTAGON® (cysteamine bitartrate) Capsules for oral administration, contain
cysteamine bitartrate, a cystine depleting agent which lowers the cystine content of cells in patients
wi... | custom-source | 2025-02-12T13:47:40.413378 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020392s010lbl.pdf', 'application_number': 20392, 'submission_type': 'SUPPL ', 'submission_number': 10} |
12,533 | NDA 20-393/S-007
NDA 20-394/S-008
Page 3
Atrovent®
(ipratropium bromide)
Nasal Spray
0.03%
21mcg/spray
ATTENTION PHARMACIST: Detach “Patient's Instructions for Use” from package
insert and dispense with the product.
Prescribing Information
DESCRIPTION
The active ingredient in ATROVENT Nasal Spray is iprat... | custom-source | 2025-02-12T13:47:40.509953 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020393s007,020394s008lbl.pdf', 'application_number': 20393, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,537 |
PRESCRIBING INFORMATION
1
ZOFRAN®
2
(ondansetron hydrochloride)
3
Injection
4
5
ZOFRAN®
6
(ondansetron hydrochloride)
7
Injection Premixed
8
DESCRIPTION
9
The active ingredient in ZOFRAN Injection and ZOFRAN Injection Premixed is ondansetron
10
hydrochloride (HCl), the racemic form of ondanse... | custom-source | 2025-02-12T13:47:40.718675 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20007s034,20403s013lbl.pdf', 'application_number': 20403, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,534 |
PRESCRIBING INFORMATION
1
Zanaflex Capsules™
1
(tizanidine hydrochloride)
2
Zanaflex® Tablets
3
(tizanidine hydrochloride)
4
5
PHARMACOKINETIC DIFFERENCES BETWEEN ZANAFLEX CAPSULES™ AND
6
ZANAFLEX® TABLETS:
7
ZANAFLEX CAPSULES™ ARE NOT BIOEQUIVALENT TO ZANAFLEX® TABLETS IN
8
THE FED STATE. T... | custom-source | 2025-02-12T13:47:40.841706 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020397s021,021447s002lbl.pdf', 'application_number': 20397, 'submission_type': 'SUPPL ', 'submission_number': 21} |
12,535 | FDA approved labeling dated October 4, 2013
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZANAFLEX® safely and effectively. See full prescribing information for
ZANAFLEX.
ZANAFLEX Capsules® (tizanidine hydrochloride) capsules, for oral use
ZANAFLEX® (... | custom-source | 2025-02-12T13:47:40.924352 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021447s011_020397s026lbl.pdf', 'application_number': 20397, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,538 |
DOCUMENT INFORMATION PAGE
This page is for FDA internal use only. Do NOT send this page with the letter.
Application #(s):
NDA 20-007/S-037
NDA 20-403/S-014
Document Type:
NDA Letters
Document Group:
NDA Supplement Approval Letters
Document Name:
Approval, effective on date of letter, based on enclo... | custom-source | 2025-02-12T13:47:40.970894 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020007s037,020403s014lbl.pdf', 'application_number': 20403, 'submission_type': 'SUPPL ', 'submission_number': 14} |
12,539 |
PRESCRIBING INFORMATION
ZOFRAN®
(ondansetron hydrochloride)
Injection
DESCRIPTION
The active ingredient in ZOFRAN Injection is ondansetron hydrochloride (HCl), the racemic
form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type.
Chemically it is (±) 1, 2, 3,... | custom-source | 2025-02-12T13:47:41.141176 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf', 'application_number': 20403, 'submission_type': 'SUPPL ', 'submission_number': 18} |
12,540 |
... | custom-source | 2025-02-12T13:47:41.291790 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s042,020403s020lbl.pdf', 'application_number': 20403, 'submission_type': 'SUPPL ', 'submission_number': 20} |
12,541 |
... | custom-source | 2025-02-12T13:47:41.438799 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020405s007lbl.pdf', 'application_number': 20405, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,543 | NDA 20-406
Page 3
(Nos. 1541, 3046, 7309, 7311)
TAP DN038-V2- Rev. Month, Year
PREVACID®
(lansoprazole)
Delayed-Release Capsules
PREVACID®
(lansoprazole)
For Delayed-Release Oral Suspension
DESCRIPTION
The active ingredient in PREVACID (lansoprazole) Delayed-Release Capsules and PREVACID
(lansopra... | custom-source | 2025-02-12T13:47:41.709607 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20406s47lbl.pdf', 'application_number': 20406, 'submission_type': 'SUPPL ', 'submission_number': 47} |
12,542 |
... | custom-source | 2025-02-12T13:47:41.741074 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020405s011lbl.pdf', 'application_number': 20405, 'submission_type': 'SUPPL ', 'submission_number': 11} |
12,544 | NDA 21-428
NDA 20-406/S-052
NDA 21-281/S-007
Page 4
(Nos. 1541, 1543, 1544, 3046, 7309, 7311)
TAPDN018-V7- Rev. Month, Year
PREVACID®
(lansoprazole)
Delayed-Release Capsules
PREVACID®
(lansoprazole)
For Delayed-Release Oral Suspension
PREVACID® SoluTabTM
(lansoprazole)
Delayed-Release Orally ... | custom-source | 2025-02-12T13:47:41.976087 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf', 'application_number': 20406, 'submission_type': 'SUPPL ', 'submission_number': 52} |
12,545 |
Page 1 of 34
(Nos. 1541, 1543, 1544, 3046, 7309, 7311)
03-5366-R24 Rev. July, 2004
PREVACID®
(lansoprazole)
Delayed-Release Capsules
PREVACID®
(lansoprazole)
For Delayed-Release Oral Suspension
PREVACID® SoluTab™
(lansoprazole)
Delayed-Release Orally Disintegrating Tablets
DESCRIP... | custom-source | 2025-02-12T13:47:42.064504 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_021428s004lbl%20.pdf', 'application_number': 20406, 'submission_type': 'SUPPL ', 'submission_number': 57} |
12,547 |
... | custom-source | 2025-02-12T13:47:42.523195 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020406s067,021281s024,021428s017lbl.pdf', 'application_number': 20406, 'submission_type': 'SUPPL ', 'submission_number': 67} |
12,546 | NDA 20-406/S-064
NDA 21-281/S-021
NDA 21-428/S012
Page 3
(Nos. 1541, 1543, 1544, 3046, 7309, 7311)
03-5530-R25, Rev. September 2006
IN-5332/S
PREVACID®
(lansoprazole)
Delayed-Release Capsules
PREVACID®
(lansoprazole)
For Delayed-Release Oral Suspension
PREVACID® SoluTab™
(lansoprazole... | custom-source | 2025-02-12T13:47:42.533698 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,021428s012lbl.pdf', 'application_number': 20406, 'submission_type': 'SUPPL ', 'submission_number': 64} |
12,549 |
HIGHLIGHTS OF PRESC... | custom-source | 2025-02-12T13:47:42.775219 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s076,021428s023lbl.pdf', 'application_number': 20406, 'submission_type': 'SUPPL ', 'submission_number': 76} |
12,548 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
PREVACID safely and e... | custom-source | 2025-02-12T13:47:43.197791 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s074,021428s021lbl.pdf', 'application_number': 20406, 'submission_type': 'SUPPL ', 'submission_number': 74} |
12,550 |
... | custom-source | 2025-02-12T13:47:43.201644 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s078-021428s025lbl.pdf', 'application_number': 20406, 'submission_type': 'SUPPL ', 'submission_number': 78} |
12,551 |
NDA 20-408/S-023
Page 3
MERCK & CO., INC.
9368202
Whitehouse Station, NJ 08889, USA
TRUSOPT
(dorzolamide hydrochloride ophthalmic solution)
Sterile Ophthalmic Solution 2%
DESCRIPTION
TRUSOPT* (dorzolamide hydrochloride ophthalmic solution) is a carbonic anhydrase inhibitor
form... | custom-source | 2025-02-12T13:47:43.237161 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20408s23lbl.pdf', 'application_number': 20408, 'submission_type': 'SUPPL ', 'submission_number': 23} |
12,552 | NDA 20-408/S-033
Page 3
TRUSOPT®
(dorzolamide hydrochloride ophthalmic solution)
Sterile Ophthalmic Solution 2%
DESCRIPTION
TRUSOPT* (dorzolamide hydrochloride ophthalmic solution) is a carbonic anhydrase inhibitor
formulated for topical ophthalmic use.
Dorzolamide hydrochloride is described chemically as... | custom-source | 2025-02-12T13:47:43.297553 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20408se5-033_trusopt_lbl.pdf', 'application_number': 20408, 'submission_type': 'SUPPL ', 'submission_number': 33} |
12,555 |
CERVIDIL®
Brand of dinoprostone vaginal insert
Rev. 04/10
Rx only
RMC 226
DESCRIPTION
Dinoprostone vaginal insert is a thin, flat, polymeric slab which is rectangular in shape
with rounded corners contained within the pouch of an off-whi... | custom-source | 2025-02-12T13:47:43.581950 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020411s027lbl.pdf', 'application_number': 20411, 'submission_type': 'SUPPL ', 'submission_number': 27} |
12,554 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information
needed to use TRUSOPT safely and effectively. See
full prescribing information for TRUSOPT.
TRUSOPT® (dorzolamide hydrochloride ophthalmic
solution) 2%
Initial U.S. Approval: 1994
----------------... | custom-source | 2025-02-12T13:47:43.639711 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020408s050lbl.pdf', 'application_number': 20408, 'submission_type': 'SUPPL ', 'submission_number': 50} |
12,556 | NDA 20-412/S-016
NDA 20-413/S-007
Page 3
S016S007Aprovlet.doc (clean copy 20Mar2002)
Page 3 of 34
ZERIT
(stavudine)
ZERIT (stavudine) Capsules
ZERIT (stavudine) for Oral Solution
(Patient Information Leaflet Included)
WARNING
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS,
INCL... | custom-source | 2025-02-12T13:47:43.742300 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20412s16lbl.pdf', 'application_number': 20412, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,553 |
NDA 20408/S-047
Page 4
TRUSOPT®
(dorzolamide hydrochloride ophthalmic solution)
Sterile Ophthalmic Solution 2%
DESCRIPTION
TRUSOPT* (dorzolamide hydrochloride... | custom-source | 2025-02-12T13:47:43.815130 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020408s047lbl.pdf', 'application_number': 20408, 'submission_type': 'SUPPL ', 'submission_number': 47} |
12,557 |
ZERIT® (stavudine)
ZERIT® (stavudine) Capsules
ZERIT® (stavudine) for Oral Solution
(Patient Information Leaflet Included)
WARNING
LACTIC
ACIDOSIS
AND
SEVERE
HEPATOMEGALY
WITH
STEATOSIS,
INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF
NUCLEOSIDE
ANALOG... | custom-source | 2025-02-12T13:47:44.059255 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s030,020413s021lbl.pdf', 'application_number': 20412, 'submission_type': 'SUPPL ', 'submission_number': 30} |
12,559 | NDA 20-412/S-016
NDA 20-413/S-007
Page 3
S016S007Aprovlet.doc (clean copy 20Mar2002)
Page 3 of 34
ZERIT
(stavudine)
ZERIT (stavudine) Capsules
ZERIT (stavudine) for Oral Solution
(Patient Information Leaflet Included)
WARNING
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS,
INCL... | custom-source | 2025-02-12T13:47:44.159169 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20412s16lbl.pdf', 'application_number': 20413, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,561 |
ZERIT® (stavudine)
ZERIT® (stavudine) Capsules
ZERIT® (stavudine) for Oral Solution
(Patient Information Leaflet Included)
WARNING
LACTIC
ACIDOSIS
AND
SEVERE
HEPATOMEGALY
WITH
STEATOSIS,
INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF
NUCLEOSIDE
ANALOG... | custom-source | 2025-02-12T13:47:44.471576 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s030,020413s021lbl.pdf', 'application_number': 20413, 'submission_type': 'SUPPL ', 'submission_number': 21} |
12,560 |
ZERIT® (stavudine)
ZERIT® (stavudine) Capsules
ZERIT® (stavudine) for Oral Solution
(Patient Information Leaflet Included)
WARNING
LACTIC
ACIDOSIS
AND
SEVERE
HEPATOMEGALY
WITH
STEATOSIS,
INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF
NUCLEOSIDE
AN... | custom-source | 2025-02-12T13:47:44.473345 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s029,020413s020lbl.pdf', 'application_number': 20413, 'submission_type': 'SUPPL ', 'submission_number': 20} |
12,558 |
... | custom-source | 2025-02-12T13:47:44.651382 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020412s036,020413s028lbl.pdf', 'application_number': 20412, 'submission_type': 'SUPPL ', 'submission_number': 36} |
12,564 |
... | custom-source | 2025-02-12T13:47:44.817606 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020412s036,020413s028lbl.pdf', 'application_number': 20413, 'submission_type': 'SUPPL ', 'submission_number': 28} |
12,563 |
ZERIT® (stavudine)
ZERIT® (stavudine) Capsules
ZERIT® (stavudine) for Oral Solution
(Patient Information Leaflet Included)
WARNING
LACTIC
ACIDOSIS
AND
SEVERE
HEPATOMEGALY
WITH
STEATOSIS,
INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF
NUCLEOSIDE
ANALOGUES
ALONE OR IN COM... | custom-source | 2025-02-12T13:47:44.982261 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020413s025,020412s033lbl.pdf', 'application_number': 20413, 'submission_type': 'SUPPL ', 'submission_number': 25} |
12,562 | ZERIT® (stavudine)
ZERIT® (stavudine) Capsules
ZERIT® (stavudine) for Oral Solution
(Patient Information Leaflet Included)
WARNING
LACTIC
ACIDOSIS
AND
SEVERE
HEPATOMEGALY
WITH
STEATOSIS,
INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF
NUCLEOSIDE
ANALOGUES
ALONE OR IN COMBINATION, INCLUDING
... | custom-source | 2025-02-12T13:47:45.039796 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s032,020413s023lbl.pdf', 'application_number': 20413, 'submission_type': 'SUPPL ', 'submission_number': 23} |
12,565 |
... | custom-source | 2025-02-12T13:47:45.294728 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020412s038,020413s030lbl.pdf', 'application_number': 20413, 'submission_type': 'SUPPL ', 'submission_number': 30} |
12,566 | Attachment 1
Page 1
Class Suicidality Labeling Language for Antidepressants
[This section should be located at the beginning of the package insert with bolded font and
enclosed in a black box]
[Insert established name]
Suicidality in Children and Adolescents
Antidepressants increased the risk of ... | custom-source | 2025-02-12T13:47:45.296421 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020415s018,021208s009lbl.pdf', 'application_number': 20415, 'submission_type': 'SUPPL ', 'submission_number': 18} |
12,567 |
logo
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior
(suicidality) in children, adolescents, and young adults in short-term studies of major
depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use... | custom-source | 2025-02-12T13:47:45.501977 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020415s023s024.pdf', 'application_number': 20415, 'submission_type': 'SUPPL ', 'submission_number': 23} |
12,568 |
logo
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior
(suicidality) in children, adolescents, and young adults in short-term studies of major
depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use... | custom-source | 2025-02-12T13:47:45.516544 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020415s023s024.pdf', 'application_number': 20415, 'submission_type': 'SUPPL ', 'submission_number': 24} |
12,570 |
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and
behavior (suicidality) in children, adolescents, and young adults in short-term studies
of major depressive disorder (MDD) and other psychiatric disorders. An... | custom-source | 2025-02-12T13:47:45.806252 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020415s030lbl.pdf', 'application_number': 20415, 'submission_type': 'SUPPL ', 'submission_number': 30} |
12,569 |
company logo
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking
and behavior (suicidality) in children, adolescents, and young adults in short-
term studies of major depressive disorder (MDD) and other psychiatric
disord... | custom-source | 2025-02-12T13:47:45.896131 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020415s026lbl.pdf', 'application_number': 20415, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,572 |
company logo
structural formula
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking
and behavior (suicidality) in children, adolescents, and young adults in short-
term studies of major depressive disorder (MDD) and other psychia... | custom-source | 2025-02-12T13:47:46.053354 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020415s032lbl.pdf', 'application_number': 20415, 'submission_type': 'SUPPL ', 'submission_number': 32} |
12,571 |
1
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking
and behavior (suicidality) in children, adolescents, and young adults in short-
term studies of major depressive disorder (MDD) and other psychiatric
disorders. Anyone considering the use of REMER... | custom-source | 2025-02-12T13:47:46.469429 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020415Orig1s031, 021208Orig1s021lbl.pdf', 'application_number': 20415, 'submission_type': 'SUPPL ', 'submission_number': 31} |
12,573 |
... | custom-source | 2025-02-12T13:47:46.855000 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf', 'application_number': 20427, 'submission_type': 'SUPPL ', 'submission_number': 10} |
12,574 |
... | custom-source | 2025-02-12T13:47:46.944806 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf', 'application_number': 20427, 'submission_type': 'SUPPL ', 'submission_number': 12} |
12,576 | 3
AZELEX® (Allergan)
(azelaic acid cream) 20%
For Dermatologic Use Only
Not for Ophthalmic Use
DESCRIPTION
AZELEX (azelaic acid cream) 20% contains azelaic acid, a naturally occurring saturated dicarboxylic acid.
Structural Formula: HOOC-(CH2)7-COOH.
Chemical Name: 1,7-heptanedicarboxylic acid
Empirical Formula: C9... | custom-source | 2025-02-12T13:47:47.052721 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20428slr016_azelex_lbl.pdf', 'application_number': 20428, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,575 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use SABRIL
safely and effectively. See full prescribing information for SABRIL.
SABRIL® (vigabatrin) tablets, for oral use
SABRIL® (vigabatrin) powder for oral solution
Initial U.S. Approval: 2009
WARNING: P... | custom-source | 2025-02-12T13:47:47.120166 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020427Orig1s014,022006Orig1s015bl.pdf', 'application_number': 20427, 'submission_type': 'SUPPL ', 'submission_number': 14} |
12,577 | custom-source | 2025-02-12T13:47:47.258333 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-430S003_Orgaran_prntlbl.pdf', 'application_number': 20430, 'submission_type': 'SUPPL ', 'submission_number': 3} | |
12,578 |
5
10
15
20
25
30
35
1
2
VESANOID®
3
(tretinoin)
4
CAPSULES
Rx only
6
7
8
9
11
12
13
14
16
17
18
19
21
22
23
24
26
27
28
29
31
32
33
34
36
WARNINGS
1. Experienced Physician and Institution
Patients with acute promyelocytic leukemia (APL) are at high r... | custom-source | 2025-02-12T13:47:47.450392 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020438s006lbl.pdf', 'application_number': 20438, 'submission_type': 'SUPPL ', 'submission_number': 6} |
12,580 | NDA 20-441/S-020
Page 2
33020-00
PULMICORT TURBUHALER® 200 mcg
(budesonide inhalation powder)
For Oral Inhalation Only.
Rx only
DESCRIPTION
Budesonide, the active component of PULMICORT TURBUHALER 200 mcg, is a corticosteroid
designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-... | custom-source | 2025-02-12T13:47:47.496540 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020441s020lbl.pdf', 'application_number': 20441, 'submission_type': 'SUPPL ', 'submission_number': 20} |
12,579 | NDA 20-439/S-011
Page 3
5 mL Carton Label, 0.25%
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NDA 20-439/S-011
Page 4
10 mL Carton Label, 0.25%
This label may not be the latest approved by FDA. ... | custom-source | 2025-02-12T13:47:47.580820 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20439s011lbl.pdf', 'application_number': 20439, 'submission_type': 'SUPPL ', 'submission_number': 11} |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.