id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
12,581 | 1
PRESCRIBING INFORMATION
1
FLOLAN®
2
(epoprostenol sodium)
3
for Injection
4
DESCRIPTION
5
FLOLAN (epoprostenol sodium) for Injection is a sterile sodium salt formulated for
6
intravenous (IV) administration. Each vial of FLOLAN contains epoprostenol sodium equivalent
7
to either 0.5 mg (500,000 ng) o... | custom-source | 2025-02-12T13:47:47.768213 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020444s016lbl.pdf', 'application_number': 20444, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,582 | NDA 20-448/S-004
Page 3
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NDA 20-448/S-004
Page 4
20-ct bottle label:
This label may not be the latest approved by FDA.
For current labeling information, please vis... | custom-source | 2025-02-12T13:47:47.780116 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020448s004lbl.pdf', 'application_number': 20448, 'submission_type': 'SUPPL ', 'submission_number': 4} |
12,584 | 1
Patient Information Leaflet
Detach and give to Patient
Rev. September 2002
Patient Information Leaflet
Questions and Answers About Taxotere® for Injection Concentrate
(generic name = docetaxel)
(pronounced as TAX-O-TEER)
What is Taxotere?
Taxotere is a medication to treat breast cancer and non-small cell lung cancer... | custom-source | 2025-02-12T13:47:48.019409 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf', 'application_number': 20449, 'submission_type': 'SUPPL ', 'submission_number': 19} |
12,585 | Patient Information Leaflet
Detach and give to Patient
Rev.May 2004
Patient Information Leaflet
Questions and Answers About Taxotere® Injection Concentrate
(generic name = docetaxel)
(pronounced as TAX-O-TEER)
What is Taxotere?
Taxotere is a medication to treat breast cancer, non-small cell lung cancer and pros... | custom-source | 2025-02-12T13:47:48.166184 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020449s028lbl.pdf', 'application_number': 20449, 'submission_type': 'SUPPL ', 'submission_number': 28} |
12,586 |
PATIENT INFORMATION LEAFLET
Detach and give to Patient
Rev. XXXX 200X
Patient Information Leaflet
Questions and Answers About Taxotere® Injection Concentrate
(generic name = docetaxel)
(pronounced as TAX-O-TEER)
What is Taxotere?
Taxotere is a medication to treat breast cancer, non-small cell lung c... | custom-source | 2025-02-12T13:47:48.338978 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449S035lbl.pdf', 'application_number': 20449, 'submission_type': 'SUPPL ', 'submission_number': 35} |
12,587 |
1
PATIENT INFORMATION LEAFLET
Detach and give to Patient
Rev October 16, 2006
PATIENT INFORMATION LEAFLET
Questions and Answers About Taxotere® Injection Concentrate
(generic name = docetaxel)
(pronounced as TAX-O-TEER)
What is Taxotere?
Taxotere is a medication to treat breast cancer, non-small ... | custom-source | 2025-02-12T13:47:48.608682 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s039lbl.pdf', 'application_number': 20449, 'submission_type': 'SUPPL ', 'submission_number': 39} |
12,588 |
________________________
__________________________
____________________________________________... | custom-source | 2025-02-12T13:47:49.166046 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s044lbl.pdf', 'application_number': 20449, 'submission_type': 'SUPPL ', 'submission_number': 44} |
12,583 | 1
Patient Information Leaflet
Detach and give to Patient
Rev. XX/XX
Patient Information Leaflet
Questions and Answers About Taxotere® for Injection Concentrate
(generic name = docetaxel)
(pronounced as TAX-O-TEER)
What is Taxotere?
Taxotere is a medication to treat breast cancer and non-small cell lung cancer. It has s... | custom-source | 2025-02-12T13:47:49.493261 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20449se1-018_Taxotere_lbl.pdf', 'application_number': 20449, 'submission_type': 'SUPPL ', 'submission_number': 18} |
12,589 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
TAXOTERE safely and effectively. See full prescribing information for
TAXOTERE.
TAXOTERE (docetaxel) Injection Concentrate, Intravenous Infusion
(IV). Initial U.S. Approval: 1996
WARNING
See full prescri... | custom-source | 2025-02-12T13:47:49.759651 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020449s045lbl.pdf', 'application_number': 20449, 'submission_type': 'SUPPL ', 'submission_number': 45} |
12,590 |
________________________
__________________________
____________________________________________... | custom-source | 2025-02-12T13:47:49.930660 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s053lbl.pdf', 'application_number': 20449, 'submission_type': 'SUPPL ', 'submission_number': 53} |
12,591 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
TAXOTERE safely and effectively. See full prescribing information for
TAXOTERE.
These highlights do not include all the information needed to use
TAXOTERE safely and effectively. See full prescribing information for
... | custom-source | 2025-02-12T13:47:52.105617 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020449s063lbl.pdf', 'application_number': 20449, 'submission_type': 'SUPPL ', 'submission_number': 63} |
12,593 |
__________________________________________________________________________________________... | custom-source | 2025-02-12T13:47:52.106178 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s069lbl.pdf', 'application_number': 20449, 'submission_type': 'SUPPL ', 'submission_number': 69} |
12,592 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use... | custom-source | 2025-02-12T13:47:52.529281 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020449s064lbl.pdf', 'application_number': 20449, 'submission_type': 'SUPPL ', 'submission_number': 64} |
12,594 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information neede... | custom-source | 2025-02-12T13:47:53.119537 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s071lbl.pdf', 'application_number': 20449, 'submission_type': 'SUPPL ', 'submission_number': 71} |
12,597 | 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 | 2025-02-12T13:47:53.340394 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20450s4s5lbl.pdf', 'application_number': 20450, 'submission_type': 'SUPPL ', 'submission_number': 5} |
12,595 |
... | custom-source | 2025-02-12T13:47:54.121200 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020449s073lbl.pdf', 'application_number': 20449, 'submission_type': 'SUPPL ', 'submission_number': 73} |
12,598 |
structural formula
NDA 020450 Cerebyx (fosphenytoin sodium) Injection
FDA Approved Labeling Text dated 10/2011
Page 1 of 22
CEREBYX®
(Fosphenytoin Sodium Injection)
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION
RATES
The rate of intravenous CEREBYX administration should not exc... | custom-source | 2025-02-12T13:47:54.204579 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf', 'application_number': 20450, 'submission_type': 'SUPPL ', 'submission_number': 8} |
12,596 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
TAXOTERE safely and effectively. See full prescribing information for
TAXOTERE.
TAXOTERE (docetaxel) Injection Concentrate, Intravenous Infusion
(IV). Initial U.S. Approval: 1996
WARNING: TOXIC DEATHS, HE... | custom-source | 2025-02-12T13:47:54.273868 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020449s075lbl.pdf', 'application_number': 20449, 'submission_type': 'SUPPL ', 'submission_number': 75} |
12,599 |
structural formula
NDA 020450 Cerebyx (fosphenytoin sodium) Injection
FDA Approved Labeling Text dated 10/2011
Page 1 of 22
CEREBYX®
(Fosphenytoin Sodium Injection)
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION
RATES
The rate of intravenous CEREBYX administration should not exc... | custom-source | 2025-02-12T13:47:54.317836 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf', 'application_number': 20450, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,602 | NDA 21-525
NDA 20-451/S-012
Page 5
PHOTOFRIN® (porfimer sodium) for Injection
DESCRIPTION
PHOTOFRIN® (porfimer sodium) for Injection is a photosensitizing agent used in the photodynamic therapy
(PDT) of tumors and of high-grade dysplasia (HGD) in Barrett’s esophagus (BE). Following reconstitution of the... | custom-source | 2025-02-12T13:47:54.631241 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20451s012_photofrin_lbl.pdf', 'application_number': 20451, 'submission_type': 'SUPPL ', 'submission_number': 12} |
12,601 |
CEREBYX®
(Fosphenytoin Sodium Injection)
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION
RATES
The rate of intravenous CEREBYX administration should not exceed 150 mg phenytoin
sodium equivalents (PE) per mi... | custom-source | 2025-02-12T13:47:54.851741 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020450s025lbl.pdf', 'application_number': 20450, 'submission_type': 'SUPPL ', 'submission_number': 25} |
12,600 |
Cerebyx NDA 020450
FDA Approved Labeling Text Jan 2014
CEREBYX®
(Fosphenytoin Sodium Injection)
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION
RATES
The rate of intravenous CEREBYX administrat... | custom-source | 2025-02-12T13:47:54.866475 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020450s023lbl.pdf', 'application_number': 20450, 'submission_type': 'SUPPL ', 'submission_number': 23} |
12,604 | custom-source | 2025-02-12T13:47:54.916362 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-452.pdf_Paraplatin_Prntlbl.pdf', 'application_number': 20452, 'submission_type': 'ORIG ', 'submission_number': 1} | |
12,603 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
PHOTOFRIN safely and effectively. See full... | custom-source | 2025-02-12T13:47:55.049349 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020451s020lbl.pdf', 'application_number': 20451, 'submission_type': 'SUPPL ', 'submission_number': 20} |
12,606 | 1 of 21
Rx only
PARAPLATIN®
(carboplatin) Injection
WARNING
PARAPLATIN (carboplatin) Injection should be administered under the supervision of a
qualified physician experienced in the use of cancer chemotherapeutic agents.
Appropriate management of therapy and complications is possible only when adequate
treatm... | custom-source | 2025-02-12T13:47:55.536097 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020452s005lbl.pdf', 'application_number': 20452, 'submission_type': 'SUPPL ', 'submission_number': 5} |
12,605 | 1 of 24
Rx only
PARAPLATIN
(carboplatin aqueous solution) INJECTION
WARNING
PARAPLATIN (carboplatin aqueous solution) INJECTION should be administered
under the supervision of a qualified physician experienced in the use of cancer
chemotherapeutic agents. Appropriate management of therapy and complications is
pos... | custom-source | 2025-02-12T13:47:55.559337 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20452scs001_paraplatin_lbl.pdf', 'application_number': 20452, 'submission_type': 'SUPPL ', 'submission_number': 1} |
12,607 |
Rx only
ETOPOPHOS
®
(etoposide phosphate)
for INJECTION
WARNINGS
ETOPOPHOS® (etoposide phosphate) for Injection should be administered under the
supervision of a qualified physician experienced in the use of cancer chemotherapeutic
agents. Severe myelosuppression with resulting infection or bleeding m... | custom-source | 2025-02-12T13:47:55.630229 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020457s013lbl.pdf', 'application_number': 20457, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,608 | Page 1
Rx only
Rev. XXXX
Nasacort® AQ
[na' za-cort]
(triamcinolone acetonide)
Nasal Spray
For intranasal use only.
Shake Well Before Using
DESCRIPTION
Triamcinolone acetonide, USP, the active ingredient in Nasacort® AQ Nasal Spray, is a
corticosteroid with a molecular weight of 434.51 and with the ch... | custom-source | 2025-02-12T13:47:55.656155 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20468slr011_nasacort_lbl.pdf', 'application_number': 20468, 'submission_type': 'SUPPL ', 'submission_number': 11} |
12,610 |
__________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:47:56.072871 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020468s024lbl.pdf', 'application_number': 20468, 'submission_type': 'SUPPL ', 'submission_number': 24} |
12,609 | Page 1
Rx only
Rev. XXXX
Nasacort® AQ
[na' za-cort]
(triamcinolone acetonide)
Nasal Spray
For intranasal use only.
Shake Well Before Using
DESCRIPTION
Triamcinolone acetonide, USP, the active ingredient in Nasacort® AQ Nasal Spray, is a
corticosteroid with a molecular weight of 434.51 and with the ch... | custom-source | 2025-02-12T13:47:56.142844 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20468slr013_nasacort_lbl.pdf', 'application_number': 20468, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,611 |
... | custom-source | 2025-02-12T13:47:56.288718 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468s033s034lbl.pdf', 'application_number': 20468, 'submission_type': 'SUPPL ', 'submission_number': 33} |
12,612 | Original
Prescription Strength
Original
Prescription Strength
Original
Prescription Strength
Multi-Symptom
Nasal Allergy Spray
120
SPRAYS
Nasal Congestion
Sneezing
Runny Nose
Itchy Nose
Relief of:
HR
24
0.57 fl. oz.
(16.9 ml)
triamcinolone acetonide (glucocorticoid)
55 mcg per spray/Nasal Allergy Symptom Reliever
NDC x... | custom-source | 2025-02-12T13:47:56.838302 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468Orig1s035lbl.pdf', 'application_number': 20468, 'submission_type': 'SUPPL ', 'submission_number': 35} |
12,614 | © 2002 Distributed by Schering-Plough HealthCare Products, Inc.
Memphis, TN 38151 USA. All rights reserved. XXXXX-XX
10 EXTENDED RELEASE TABLETS
0
8
41100 80208
The graphics on the front panel of this carton constitute
trademarks of Schering Corporation.
00000000
00000000
Pseudoephedrine Sulfate 120 mg/Nasal Decong... | custom-source | 2025-02-12T13:47:56.903619 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19670s019,20470s022lbl.pdf', 'application_number': 20470, 'submission_type': 'SUPPL ', 'submission_number': 22} |
12,615 | Page 1 of 14
Part number 42000R00-Rev. March 2005
ZYFLO®
(zileuton tablets)
Tear at perforation to dispense patient information.
Rx only
DESCRIPTION
Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the
formation of leukotrienes from arachidonic acid. Zileuton has the... | custom-source | 2025-02-12T13:47:56.923812 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020471s011lbl.pdf', 'application_number': 20471, 'submission_type': 'SUPPL ', 'submission_number': 11} |
12,616 |
ZYFLO®
(zileuton tablets)
DESCRIPTION
Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the
formation of leukotrienes from arachidonic acid. Zileuton has the chemical name (±)-1
(1-Benzo[b]thien-2-ylethyl)-1-hydroxyurea and the following chemical structure:... | custom-source | 2025-02-12T13:47:57.223314 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020471s017lbl.pdf', 'application_number': 20471, 'submission_type': 'SUPPL ', 'submission_number': 17} |
12,613 | Nasal Congestion
Sneezing
Runny Nose
Itchy Nose
Relief of:
HR
24
®
triamcinolone acetonide (glucocorticoid)
55 mcg per spray/Nasal Allergy Symptom Reliever
Multi-Symptom
Nasal Allergy Spray
Children’s
Children’s
22
ages
years
& older
NDC 41167-5900-2
Children’s
Dist. by: Chattem, Inc.,
a Sanofi Company
Cha tanooga, TN ... | custom-source | 2025-02-12T13:47:57.391563 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020468Orig1s040lbl.pdf', 'application_number': 20468, 'submission_type': 'SUPPL ', 'submission_number': 40} |
12,618 | NDA 20-474/SLR-016
Page 3
Packaging Insert
Vexol ® 1%
(rimexolone ophthalmic suspension)
DESCRIPTION:
VEXOL®1 % Ophthalmic Suspension is a sterile, multi-dose topical ophthalmic suspension
containing the corticosteroid, rimexolone. Rimexolone is a white, water insoluble powder with an
empirical formula ... | custom-source | 2025-02-12T13:47:57.458943 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20474slr016_vexol_lbl.pdf', 'application_number': 20474, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,617 |
ESTRING®
(estradiol vaginal ring)
PHYSICIAN’S ... | custom-source | 2025-02-12T13:47:57.542893 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020472s012s013lbl.pdf', 'application_number': 20472, 'submission_type': 'SUPPL ', 'submission_number': 12} |
12,619 |
_________________
_______________
______________
_____________
____________________
___________________
_______________
_______________
_______________
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed t... | custom-source | 2025-02-12T13:47:57.626035 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020475s021lbl.pdf', 'application_number': 20475, 'submission_type': 'SUPPL ', 'submission_number': 21} |
12,621 |
----------
ULTANE - sevoflurane liquid
Abbott Laboratories
ULTANE®
(sevoflurane)
volatile liquid for inhalation
NOVAPLUS™
DESCRIPTION
ULTANE (sevoflurane), volatile liquid for inhalation, a nonflammable and nonexplosive liquid
administered by vaporization, is a halogenated general inhalati... | custom-source | 2025-02-12T13:47:57.941684 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020478s019s020lbl.pdf', 'application_number': 20478, 'submission_type': 'SUPPL ', 'submission_number': 19} |
12,622 |
----------
ULTANE - sevoflurane liquid
Abbott Laboratories
ULTANE®
(sevoflurane)
volatile liquid for inhalation
NOVAPLUS™
DESCRIPTION
ULTANE (sevoflurane), volatile liquid for inhalation, a nonflammable and nonexplosive liquid
administered by vaporization, is a halogenated general inhalati... | custom-source | 2025-02-12T13:47:58.047045 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020478s019s020lbl.pdf', 'application_number': 20478, 'submission_type': 'SUPPL ', 'submission_number': 20} |
12,624 | ATTACHMENT
DRAFT
6536-00/July 2000
Innohep
Rx only
(tinzaparin sodium injection)
For Subcutaneous Use Only
DESCRIPTION
INNOHEP is a sterile solution, containing tinzaparin sodium, a low molecular weight heparin. It
is available in a multiple dose 2 mL vial.
Each 2 mL vial contains 20,000 anti-Factor Xa IU (anti-... | custom-source | 2025-02-12T13:47:58.152504 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20484lbl.pdf', 'application_number': 20484, 'submission_type': 'ORIG ', 'submission_number': 1} |
12,623 |
ULTANE®
(sevoflurane)
volatile liquid for inhalation
DESCRIPTION
ULTANE (sevoflurane), volatile liquid for inhalation, a nonflammable and nonexplosive liquid
administered by vaporization, is a halogenated general inhalation anesthetic drug. Sevoflurane is
fluoromethyl 2,2,2,-... | custom-source | 2025-02-12T13:47:58.183132 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020478s025s026lbl.pdf', 'application_number': 20478, 'submission_type': 'SUPPL ', 'submission_number': 25} |
12,625 |
Innohep®
Rx only
(tinzaparin sodium injection)
For Subcutaneous (SC) Use Only
WARNING: SPINAL/EPIDURAL HEMATOMAS
Epidural or spinal hematomas may occur in patients who are anticoagulated with low
molecula... | custom-source | 2025-02-12T13:47:58.381421 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020484s013lbl.pdf', 'application_number': 20484, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,626 |
... | custom-source | 2025-02-12T13:47:58.532455 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020484s014lbl.pdf', 'application_number': 20484, 'submission_type': 'SUPPL ', 'submission_number': 14} |
12,627 | 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 | 2025-02-12T13:47:58.580531 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20485s005lbl.pdf', 'application_number': 20485, 'submission_type': 'SUPPL ', 'submission_number': 5} |
12,629 | NDA 20-487/S-007
Page 2
PRESCRIBING INFORMATION
VALTREX®
(valacyclovir hydrochloride)
Caplets
DESCRIPTION
VALTREX (valacyclovir hydrochloride) is the hydrochloride salt of L-valyl ester of the
antiviral drug acyclovir (ZOVIRAX® Brand, GlaxoSmithKline).
VALTREX Caplets are for oral administration. ... | custom-source | 2025-02-12T13:47:58.665459 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020487s007rel2_lbl.pdf', 'application_number': 20487, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,628 | 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 | 2025-02-12T13:47:58.686932 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020485Orig1s009Lbl.pdf', 'application_number': 20485, 'submission_type': 'SUPPL ', 'submission_number': 9} |
12,630 | 21
22
23
24
25
26
27
28
29
30
31
32
33
1
2
3
4
PRESCRIBING INFORMATION
VAL TREX~
(valacyclovir hydrochloride)
Caplets
5
6
7
8
9
10
11
12
13
14
15
DESCRIPTION
VAL TREX (val
acyclovir hydrochloride) is the hydrochloride salt of L-valyl ester of the
antiviral drug acyclovir (ZOVIRAXQ! Brand, GlaxoSmithKline).
VAL TREX Ca... | custom-source | 2025-02-12T13:47:58.879543 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020487s013lbl.pdf', 'application_number': 20487, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,633 | Page 3
NDA 20-490/S-007
NDA 20-613/S-018
NDA 21-262/S-006
ALPHAGAN
(brimonidine tartrate ophthalmic solution) 0.5%
Sterile
DESCRIPTION
ALPHAGAN (brimonidine tartrate ophthalmic solution) 0.5% is a relatively selective alpha-2
adrenergic agonist for ophthalmic use. The chemical name of bri... | custom-source | 2025-02-12T13:47:59.039156 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf', 'application_number': 20490, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,632 |
... | custom-source | 2025-02-12T13:47:59.182446 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020489s033lbl.pdf', 'application_number': 20489, 'submission_type': 'SUPPL ', 'submission_number': 33} |
12,631 |
... | custom-source | 2025-02-12T13:47:59.314049 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020489s025lbl.pdf', 'application_number': 20489, 'submission_type': 'SUPPL ', 'submission_number': 25} |
12,634 | custom-source | 2025-02-12T13:47:59.390477 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-491S003.pdf', 'application_number': 20491, 'submission_type': 'SUPPL ', 'submission_number': 3} | |
12,637 |
... | custom-source | 2025-02-12T13:47:59.675220 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s027lbl.pdf', 'application_number': 20496, 'submission_type': 'SUPPL ', 'submission_number': 27} |
12,636 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ... | custom-source | 2025-02-12T13:47:59.731317 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s026lbl.pdf', 'application_number': 20496, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,635 |
AMARYL®
(glimepiride tablets)
1, 2, and 4 mg
DESCRIPTION
AMARYL® (glimepiride tablets) is an oral blood-glucose-lowering drug of the sulfonylurea
class. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless
powder formulated into tablets of 1... | custom-source | 2025-02-12T13:47:59.772017 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf', 'application_number': 20496, 'submission_type': 'SUPPL ', 'submission_number': 19} |
12,638 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
FARESTON® safely and eff... | custom-source | 2025-02-12T13:47:59.863611 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020497s006lbl.pdf', 'application_number': 20497, 'submission_type': 'SUPPL ', 'submission_number': 6} |
12,639 | 1
Rev 10-25-04
PCC
CASODEX®
(bicalutamide)
TABLETS
DESCRIPTION
CASODEX® (bicalutamide) Tablets for oral administration contain 50 mg of bicalutamide, a
non-steroidal antiandrogen with no other known endocrine activity. The chemical name is
propanamide, N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluoro... | custom-source | 2025-02-12T13:48:00.094667 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020498s016lbl.pdf', 'application_number': 20498, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,640 | Rev 10-12-05
PCC XXXXXX
CASODEX®
(bicalutamide)
TABLETS
DESCRIPTION
CASODEX® (bicalutamide) Tablets for oral administration contain 50 mg of bicalutamide, a
non-steroidal antiandrogen with no other known endocrine activity. The chemical name is
propanamide, N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fl... | custom-source | 2025-02-12T13:48:00.272544 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020498s018lbl.pdf', 'application_number': 20498, 'submission_type': 'SUPPL ', 'submission_number': 18} |
12,641 |
v HIGHLIGHTS OF PRESCRIBING IN... | custom-source | 2025-02-12T13:48:00.276268 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020498s019s021lbl.pdf', 'application_number': 20498, 'submission_type': 'SUPPL ', 'submission_number': 21} |
12,643 |
PRESCRIBING INFORMATION
MEPRON
®
(atovaquone)
Suspension
DESCRIPTION
MEPRON (atovaquone) is an antiprotozoal agent. The chemical name of atovaquone is trans-
2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone is a yellow
crystalline solid that is practically insoluble ... | custom-source | 2025-02-12T13:48:00.368499 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020500s014lbl.pdf', 'application_number': 20500, 'submission_type': 'SUPPL ', 'submission_number': 14} |
12,644 |
... | custom-source | 2025-02-12T13:48:00.586200 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020500s015lbl.pdf', 'application_number': 20500, 'submission_type': 'SUPPL ', 'submission_number': 15} |
12,645 | 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 | 2025-02-12T13:48:00.748028 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf', 'application_number': 20505, 'submission_type': 'SUPPL ', 'submission_number': 17} |
12,646 | 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 | 2025-02-12T13:48:00.984376 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20505s022,025,20844s019,021lbl.pdf', 'application_number': 20505, 'submission_type': 'SUPPL ', 'submission_number': 22} |
12,647 | 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 | 2025-02-12T13:48:01.059266 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20505s022,025,20844s019,021lbl.pdf', 'application_number': 20505, 'submission_type': 'SUPPL ', 'submission_number': 25} |
12,648 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do no... | custom-source | 2025-02-12T13:48:02.084063 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf', 'application_number': 20505, 'submission_type': 'SUPPL ', 'submission_number': 31} |
12,649 |
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 | 2025-02-12T13:48:02.386672 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s034lbl.pdf', 'application_number': 20505, 'submission_type': 'SUPPL ', 'submission_number': 39} |
12,651 |
NDA 020505/S-042 & NDA 020844/S-036
FDA Approved Labeling Text dated July 15, 2011
HIGHLIGHTS OF PRESCRIBING INFO... | custom-source | 2025-02-12T13:48:03.645637 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s042,020844s036lbl.pdf', 'application_number': 20505, 'submission_type': 'SUPPL ', 'submission_number': 42} |
12,650 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include a... | custom-source | 2025-02-12T13:48:03.807763 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037lbl.pdf', 'application_number': 20505, 'submission_type': 'SUPPL ', 'submission_number': 40} |
12,655 | Lac-Hydrin® 12%*
(ammonium lactate) Cream
For Dermatologic use only. Not for Ophthalmic, Oral or Intravaginal use.
DESCRIPTION
*Lac-Hydrin is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammo-
nium lactate with a pH of 4.4-5.4. Lac-Hydrin® 12% (ammonium lactate) Cream also contains cetyl
al... | custom-source | 2025-02-12T13:48:04.647826 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20508s006lbl.pdf', 'application_number': 20508, 'submission_type': 'SUPPL ', 'submission_number': 6} |
12,652 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include a... | custom-source | 2025-02-12T13:48:04.906895 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037lbl.pdf', 'application_number': 20505, 'submission_type': 'SUPPL ', 'submission_number': 45} |
12,653 |
... | custom-source | 2025-02-12T13:48:05.227707 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s053,020844s044lbl.pdf', 'application_number': 20505, 'submission_type': 'SUPPL ', 'submission_number': 53} |
12,656 | 1
1
2
3
GEMZAR®
4
(GEMCITABINE HCL)
5
FOR INJECTION
6
7
DESCRIPTION
8
Gemzar® (gemcitabine HCl) is a nucleoside analogue that exhibits antitumor activity. Gemcitabine HCl is 2'-
9
deoxy-2',2'-difluorocytidine monohydrochloride (ß-isomer).
10
The structural formula is as follows:
11
12
O
F
F
OH
N
N
O
NH 2 •HCl
H
HO
13
1... | custom-source | 2025-02-12T13:48:05.526215 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020509s013lbl.pdf', 'application_number': 20509, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,654 |
... | custom-source | 2025-02-12T13:48:05.573501 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s055,020844s046lbl.pdf', 'application_number': 20505, 'submission_type': 'SUPPL ', 'submission_number': 55} |
12,657 | 1
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
A 3.0 NL 4061 AMP
GEMZAR®
(GEMCITABINE HCl)
FOR INJECTION
DESCRIPTION
Gemzar® (gemcitabine HCl) is a nucleoside analogue that exhibits antitumor activity.
Gemcitabine HCl is 2´-deoxy-2´,2´-difluorocytidine monohydrochl... | custom-source | 2025-02-12T13:48:05.788162 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020509s029lbl.pdf', 'application_number': 20509, 'submission_type': 'SUPPL ', 'submission_number': 29} |
12,658 |
1
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
B1.0 NL 4063 AMP
GEMZAR®
(GEMCITABINE HCl)
FOR INJECTION
DESCRIPTION
Gemzar® (gemcitabine HCl) is a nucleoside analogue that exhibits antitumor activity.
Gemcitabine HCl is 2... | custom-source | 2025-02-12T13:48:05.960021 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020509s033lbl.pdf', 'application_number': 20509, 'submission_type': 'SUPPL ', 'submission_number': 33} |
12,662 |
Package Insert –Front Panel
3
Aphthasol®
(amlexanox oral paste),
For Oral Cavity Use Only
Not for Ophthalmic Use
Description: Aphthasol contains 5% amlexanox in an adhesive oral paste. Chemically,
amlexanox is 2-amino-7-isopropyl-5-oxo-5H-[1]benzopyrano[2,3-b] pyridine-3-carboxylic acid.
It ... | custom-source | 2025-02-12T13:48:06.580041 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20511s002lbl.pdf', 'application_number': 20511, 'submission_type': 'SUPPL ', 'submission_number': 2} |
12,659 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
GEMZAR safely and effectively. See full prescribing information fo... | custom-source | 2025-02-12T13:48:06.645668 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020509s064lbl.pdf', 'application_number': 20509, 'submission_type': 'SUPPL ', 'submission_number': 64} |
12,661 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Gem... | custom-source | 2025-02-12T13:48:06.751666 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020509s075lbl.pdf', 'application_number': 20509, 'submission_type': 'SUPPL ', 'submission_number': 75} |
12,660 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
GEMZAR safely and effectively. See full prescribing information for
GEMZAR.
GEMZAR (gemcitabine for injection) Powder, Lyophilized, For Solution
For lutravenous Use
Initial
U.S. Approval: 1996
----------------------... | custom-source | 2025-02-12T13:48:06.788966 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020509s069lbl.pdf', 'application_number': 20509, 'submission_type': 'SUPPL ', 'submission_number': 69} |
12,663 | custom-source | 2025-02-12T13:48:06.931626 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf', 'application_number': 20516, 'submission_type': 'SUPPL ', 'submission_number': 4} | |
12,665 | Structural Formula
LUPRON® INJECTION
(leuprolide acetate)
Rx only
DESCRIPTION
Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing
hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical
name is 5-oxo... | custom-source | 2025-02-12T13:48:07.417244 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf', 'application_number': 20517, 'submission_type': 'SUPPL ', 'submission_number': 24} |
12,666 | Structural Formula
LUPRON® INJECTION
(leuprolide acetate)
Rx only
DESCRIPTION
Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing
hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical
name is 5-oxo... | custom-source | 2025-02-12T13:48:07.690512 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf', 'application_number': 20517, 'submission_type': 'SUPPL ', 'submission_number': 29} |
12,667 |
NDA 020517/S-031
Lupron Depot-3 Month
22.5 mg
(leuprolide acetate for depot
suspension)
Reference ID: 2888059
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
----------
LUPRON DEPOT... | custom-source | 2025-02-12T13:48:07.707793 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s031lbl.pdf', 'application_number': 20517, 'submission_type': 'SUPPL ', 'submission_number': 31} |
12,664 | 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 | 2025-02-12T13:48:08.019711 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020516Orig1s030lbl.pdf', 'application_number': 20516, 'submission_type': 'SUPPL ', 'submission_number': 30} |
12,668 |
... | custom-source | 2025-02-12T13:48:08.349392 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf', 'application_number': 20517, 'submission_type': 'SUPPL ', 'submission_number': 32} |
12,669 |
... | custom-source | 2025-02-12T13:48:08.568552 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020517s033lbl.pdf', 'application_number': 20517, 'submission_type': 'SUPPL ', 'submission_number': 33} |
12,671 |
... | custom-source | 2025-02-12T13:48:08.794173 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019732s042,020517s038lbl.pdf', 'application_number': 20517, 'submission_type': 'SUPPL ', 'submission_number': 38} |
12,670 |
LUPRON DEPOT® 7.5 mg
(leuprolide acetate for depot suspension)
Rx only
DESCRIPTION
Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-
releasing hormone (GnRH or LH-RH). The analog possesses greater potency than th... | custom-source | 2025-02-12T13:48:08.822761 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019732s040,020517s035lbl.pdf', 'application_number': 20517, 'submission_type': 'SUPPL ', 'submission_number': 35} |
12,672 | NDA 19-655/S-041
NDA 19-910/S-029
NDA 20-518/S-013
Page 3
PRESCRIBING INFORMATION
RETROVIR®
FINAL AGREED-UPON PI 05/08/2006
(zidovudine)
Tablets
RETROVIR®
(zidovudine)
Capsules
RETROVIR®
(zidovudine)
Syrup
WARNING
RETROVIR (ZIDOVUDINE) HAS BEEN ASSOCIATED WITH HEMATOLOGIC
TOXICITY INCLUDI... | custom-source | 2025-02-12T13:48:08.881404 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s41,019910s29,020518s13lbl.pdf', 'application_number': 20518, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,673 |
... | custom-source | 2025-02-12T13:48:09.082517 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033,019655s046,020518s016lbl.pdf', 'application_number': 20518, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,675 |
LOPROX® CREAM
(ciclopirox) 0.77%
FOR DERMATOLOGIC USE ONLY.
NOT FOR USE IN EYES.
Rx Only
DESCRIPTION
LOPROX® Cream (ciclopirox) 0.77% is for topical use.
Each gram of LOPROX® Cream contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible
vanishing ... | custom-source | 2025-02-12T13:48:09.238511 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf', 'application_number': 20519, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,678 | Nutropin AQ® [somatropin (rDNA origin) injection]
Nutropin AQ − Genentech, Inc.
November 2004
1
Clean Package Insert
Nutropin AQ
[somatropin (rDNA origin) injection]
DESCRIPTION
Nutropin AQ is a human growth hormone (hGH) produced by recombinant DNA technology.
Nutropin AQ has 191 amino acid residues an... | custom-source | 2025-02-12T13:48:09.651157 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022_rel2_lbl.pdf', 'application_number': 20522, 'submission_type': 'SUPPL ', 'submission_number': 21} |
12,677 | custom-source | 2025-02-12T13:48:09.714218 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-522S013_Somatropin_prntlbl.pdf', 'application_number': 20522, 'submission_type': 'SUPPL ', 'submission_number': 13} | |
12,674 |
... | custom-source | 2025-02-12T13:48:09.761445 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019655s048,020518s018lbl.pdf', 'application_number': 20518, 'submission_type': 'SUPPL ', 'submission_number': 18} |
12,676 | 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 | 2025-02-12T13:48:10.183111 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020520Orig1s030lbl.pdf', 'application_number': 20520, 'submission_type': 'SUPPL ', 'submission_number': 30} |
12,681 | 1
PREMPRO™
(conjugated estrogens/medroxyprogesterone acetate tablets)
PREMPHASE
(conjugated estrogens/medroxyprogesterone acetate tablets)
only
WARNING
Estrogens and progestins should not be used for the prevention of cardiovascular disease.
The Women’s Health Initiative (WHI) reported increased risks of m... | custom-source | 2025-02-12T13:48:10.408298 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527s30bl.pdf', 'application_number': 20527, 'submission_type': 'SUPPL ', 'submission_number': 30} |
12,680 |
... | custom-source | 2025-02-12T13:48:10.509048 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020522s051lbl.pdf', 'application_number': 20522, 'submission_type': 'SUPPL ', 'submission_number': 51} |
12,684 | PREMPRO™
(conjugated estrogens/medroxyprogesterone acetate tablets)
PREMPHASE®
(conjugated estrogens/medroxyprogesterone acetate tablets)
Rx only
WARNINGS
CARDIOVASCULAR AND OTHER RISKS
Estrogens plus progestins should not be used for the prevention of cardiovascular disease or
dementia. (See CLINICAL STUDIE... | custom-source | 2025-02-12T13:48:10.836637 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020527s043lbl.pdf', 'application_number': 20527, 'submission_type': 'SUPPL ', 'submission_number': 43} |
12,683 | NDA 20-527/S-036
Page 3
PREMPRO
(conjugated estrogens/medroxyprogesterone acetate tablets)
PREMPHASE
(conjugated estrogens/medroxyprogesterone acetate tablets)
] only
WARNING
Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia.
(See WARNINGS, Cardiovascula... | custom-source | 2025-02-12T13:48:12.923884 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020527s036lbl.pdf', 'application_number': 20527, 'submission_type': 'SUPPL ', 'submission_number': 36} |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.