id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
14,552 | NDA 021168/S-016/S-017/S-020/S-022
Depakote ER (divalproex sodium) Tablet, Extended Release for Oral use
FDA Approved Labeling Text dated October 7, 2011
Page 1 of 66
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Depakote ER safely and effectively. See f... | custom-source | 2025-02-12T13:52:51.347973 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf', 'application_number': 21168, 'submission_type': 'SUPPL ', 'submission_number': 17} |
14,550 | DN1172V1 03-5472 Depakote ER
July 12, 2006 Page 1 of 39
DEPAKOTE® ER
(divalproex sodium)
extended-release tablets
BOX WARNING
HEPATOTOXICITY
HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS
RECEIVING VALPROIC ACID AND ITS DERIVATIVES. EXPERIENCE HAS INDICATED
THAT CHILDREN UNDER THE AGE OF TWO... | custom-source | 2025-02-12T13:52:51.586928 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf', 'application_number': 21168, 'submission_type': 'SUPPL ', 'submission_number': 14} |
14,557 | NDA 21168/S-030
Page 3
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NDA 21168/S-030
Page 4
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NDA 21168/S-... | custom-source | 2025-02-12T13:52:52.253921 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168Orig1s030lbl.pdf', 'application_number': 21168, 'submission_type': 'SUPPL ', 'submission_number': 30} |
14,556 |
... | custom-source | 2025-02-12T13:52:52.563445 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021168s029lbl.pdf', 'application_number': 21168, 'submission_type': 'SUPPL ', 'submission_number': 29} |
14,555 |
... | custom-source | 2025-02-12T13:52:52.576498 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021168s026lbl.pdf', 'application_number': 21168, 'submission_type': 'SUPPL ', 'submission_number': 26} |
14,554 |
... | custom-source | 2025-02-12T13:52:52.667188 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021168s025lbl.pdf', 'application_number': 21168, 'submission_type': 'SUPPL ', 'submission_number': 25} |
14,558 |
... | custom-source | 2025-02-12T13:52:53.215678 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021168s033lbl.pdf', 'application_number': 21168, 'submission_type': 'SUPPL ', 'submission_number': 33} |
14,559 | DESCRIPTION
REMINYL® (galantamine hydrobromide), extracted from the bulbs of the daffodil, Narcissus
pseudonarcissus, is a reversible, competitive acetylcholinesterase inhibitor. It is known
chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-
benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide... | custom-source | 2025-02-12T13:52:53.218118 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21169lbl.pdf', 'application_number': 21169, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,560 |
HIGHLIGHTS OF PRES... | custom-source | 2025-02-12T13:52:53.388870 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021169s024,021224s022,021615s016lbl.pdf', 'application_number': 21169, 'submission_type': 'SUPPL ', 'submission_number': 24} |
14,561 |
str
u
ct
ur
a
l
form
ula
NDA 21169/S026
NDA 21224/S025
NDA 21615/S018
Page 3
RAZADYNE® ER
galantamine HBr
EXTENDED-RELEASE CAPSULES
RAZADYNE®
galantamine HBr
TABLETS AND ORAL SOLUTION
DESCRIPTION
RAZADYNE® ER/RAZADYNE® (galantamine hydrobromide) is galantamine hydrobromide, a
re... | custom-source | 2025-02-12T13:52:53.546928 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s026,021224s025,021615s018lbl.pdf', 'application_number': 21169, 'submission_type': 'SUPPL ', 'submission_number': 26} |
14,571 | custom-source | 2025-02-12T13:52:53.724933 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa_prntlbl.pdf', 'application_number': 21175, 'submission_type': 'ORIG ', 'submission_number': 1} | |
14,564 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:52:53.868394 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021172s045s049lbl.pdf', 'application_number': 21172, 'submission_type': 'SUPPL ', 'submission_number': 45} |
14,572 |
PROPOSED WELCHOL
PACKAGE INSERT
WelChol Tablets
(colesevelam hydrochloride)
[koe le sev´ e lam]
Rx only
DESCRIPTION
WelChol contains colesevelam hydrochloride (hereafter referred to as colesevelam), a non-absorbed,
polymeric, lipid-lowering agent intended for oral administration. Colesevelam is a high... | custom-source | 2025-02-12T13:52:54.076097 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021176s004lbl.pdf', 'application_number': 21176, 'submission_type': 'SUPPL ', 'submission_number': 4} |
14,573 | NDA 21-176/S-009
Page 3
WelChol Tablets
(colesevelam hydrochloride)
[koe le sev´ e lam]
DESCRIPTION
WelChol contains colesevelam hydrochloride (hereafter referred to as colesevelam), a non-absorbed,
polymeric, lipid-lowering agent intended for oral administration. Colesevelam is a high capacity bile
acid... | custom-source | 2025-02-12T13:52:54.076944 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176slr009_welChol_lbl.pdf', 'application_number': 21176, 'submission_type': 'SUPPL ', 'submission_number': 9} |
14,575 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
WELCHOL safel... | custom-source | 2025-02-12T13:52:54.724970 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf', 'application_number': 21176, 'submission_type': 'SUPPL ', 'submission_number': 22} |
14,576 | __________________________
________________________
______________________
_________________________
_____________________
______________________________________
__________________________
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use WELCHOL safely
and ... | custom-source | 2025-02-12T13:52:54.809383 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021176s027,022362s002lbl.pdf', 'application_number': 21176, 'submission_type': 'SUPPL ', 'submission_number': 27} |
14,577 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all th... | custom-source | 2025-02-12T13:52:54.841630 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s030,022362s010lbl.pdf', 'application_number': 21176, 'submission_type': 'SUPPL ', 'submission_number': 30} |
14,578 |
... | custom-source | 2025-02-12T13:52:54.920480 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf', 'application_number': 21176, 'submission_type': 'SUPPL ', 'submission_number': 34} |
14,581 | NDA 21-178/S-009
Page 3
GLUCOVANCE®
(Glyburide and Metformin HCl Tablets)
1.25 mg/250 mg
2.5 mg/500 mg
5 mg/500 mg
DESCRIPTION
GLUCOVANCE® (Glyburide and Metformin HCl Tablets) contains two oral antihyperglycemic drugs
used in the management of type 2 diabetes, glyburide and metformin hydrochloride.... | custom-source | 2025-02-12T13:52:55.263597 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021178s009lbl.pdf', 'application_number': 21178, 'submission_type': 'SUPPL ', 'submission_number': 9} |
14,579 |
Bristol-Myers Squibb Company
GLUCOVANCE
Rx only
(Glyburide and Metformin HCl Tablets)
1.25 mg/250 mg
2.5 mg/500 mg
5 mg/500 mg
DESCRIPTION
GLUCOVANCE(Glyburide and Metformin HCl Tablets) contains two oral antihyper-glycemic drugs
used in the management of type 2 diabetes, glyburide and ... | custom-source | 2025-02-12T13:52:55.591190 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21178s4lbl.pdf', 'application_number': 21178, 'submission_type': 'SUPPL ', 'submission_number': 4} |
14,580 | NDA 21-178/S-007
Page 3
Bristol-Myers Squibb Company
Rx only
GLUCOVANCE
(Glyburide and Metformin HCl Tablets)
1.25 mg/250 mg
2.5 mg/500 mg
5 mg/500 mg
DESCRIPTION
GLUCOVANCE(Glyburide and Metformin HCl Tablets) contains two oral antihyperglycemic drugs
used in the management of type 2 diabetes, gl... | custom-source | 2025-02-12T13:52:55.695131 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21178se5-007_glucovance_lbl.pdf', 'application_number': 21178, 'submission_type': 'SUPPL ', 'submission_number': 7} |
14,582 |
GLUCOVANCE®
(Glyburide and Metformin HCl) Tablets
1.25 mg/250 mg
2.5 mg/500 mg
5 mg/500 mg
DESCRIPTION
GLUCOVANCE® (Glyburide and Metformin HCl) Tablets contain 2 oral antihyperglycemic
drugs used in the management of type 2 diabetes, glyburide and metformin hydrochloride.
Glyburide is an oral a... | custom-source | 2025-02-12T13:52:55.758959 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021178s012lbl.pdf', 'application_number': 21178, 'submission_type': 'SUPPL ', 'submission_number': 12} |
14,583 | (logo) Renagel® Tablets
(sevelamer hydrochloride) 400 and 800 mg
(logo) Renagel® Capsules
(sevelamer hydrochloride) 403 mg
[se vel′′′′ a mer]
DESCRIPTION
The active ingredient in Renagel* Tablets and Capsules is sevelamer hydrochloride, a
polymeric phosphate binder intended for oral administration. Sevelamer hydrochl... | custom-source | 2025-02-12T13:52:55.775914 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21179lbl.pdf', 'application_number': 21179, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,585 | NDA 21-179/S-021
Page 3
(LOGO) RENAGEL® TABLETS
(SEVELAMER HYDROCHLORIDE) 400 AND 800 MG
[se vel´ a mer]
Description
The active ingredient in Renagel* Tablets is sevelamer hydrochloride, a polymeric phosphate binder
intended for oral administration. Sevelamer hydrochloride is poly(allylamine hydrochloride)
c... | custom-source | 2025-02-12T13:52:56.026801 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021179s021lbl.pdf', 'application_number': 21179, 'submission_type': 'SUPPL ', 'submission_number': 21} |
14,584 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Renagel
safely and effectively. See full prescribing information for Renagel.
Renagel® (sevelamer hydrochloride) Tablets for oral use
Initial U.S. Approval: 2000
----------------------------INDICATIONS AN... | custom-source | 2025-02-12T13:52:56.237115 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021179s020lbl.pdf', 'application_number': 21179, 'submission_type': 'SUPPL ', 'submission_number': 20} |
14,587 | 631-10-662-
ORTHO EVRA
(NORELGESTROMIN / ETHINYL ESTRADIOL
TRANSDERMAL SYSTEM)
Patients should be counseled that this product does not protect against HIV
infection (AIDS) and other sexually transmitted diseases.
Rx only
DESCRIPTION
ORTHO EVRA is a combination transdermal contraceptive patch with a contact ... | custom-source | 2025-02-12T13:52:56.238737 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021180s015lbl.pdf', 'application_number': 21180, 'submission_type': 'SUPPL ', 'submission_number': 15} |
14,586 |
... | custom-source | 2025-02-12T13:52:56.277675 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021179s032lbl.pdf', 'application_number': 21179, 'submission_type': 'SUPPL ', 'submission_number': 32} |
14,588 | ORTHO EVRA®
(norelgestromin / ethinyl estradiol
TRANSDERMAL SYSTEM)
Patients should be counseled that this product does not protect against HIV
infection (AIDS) and other sexually transmitted diseases.
Rx only
DESCRIPTION
ORTHO EVRA® is a combination transdermal contraceptive patch with a contact
surface area ... | custom-source | 2025-02-12T13:52:56.655728 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021180s022lbl.pdf', 'application_number': 21180, 'submission_type': 'SUPPL ', 'submission_number': 22} |
14,590 |
ORTHO EVRA®
(norelgestromin / ethinyl estradiol
TRANSDERMAL SYSTEM)
Patients should be counseled that this product does not protect against HIV
infection (AIDS) and other sexually transmitted diseases.
DESCRIPTION
ORTHO EVRA® is a combination transdermal contraceptive patch with a contact
surfac... | custom-source | 2025-02-12T13:52:57.294036 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf', 'application_number': 21180, 'submission_type': 'SUPPL ', 'submission_number': 30} |
14,589 |
ORTHO EVRA®
(norelgestromin / ethinyl estradiol
TRANSDERMAL SYSTEM)
Patients should be counseled that this product does not protect against HIV
infection (AIDS) and other sexually transmitted diseases.
DESCRIPTION
ORTHO EVRA® is a combination transdermal contraceptive patch with a contact
surface ar... | custom-source | 2025-02-12T13:52:57.530959 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s029lbl.pdf', 'application_number': 21180, 'submission_type': 'SUPPL ', 'submission_number': 29} |
14,591 |
ORTHO EVRA®
(norelgestromin / ethinyl estradiol
TRANSDERMAL SYSTEM)
Patients should be counseled that this product does not protect against HIV
infection (AIDS) and other sexually transmitted diseases.
DESCRIPTION
ORTHO EVRA® is a combination transdermal contraceptive patch with a contact
surface ar... | custom-source | 2025-02-12T13:52:57.726114 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s033lbl.pdf', 'application_number': 21180, 'submission_type': 'SUPPL ', 'submission_number': 33} |
14,593 |
ORTHO EVRA®
(norelgestromin / ethinyl estradiol
TRANSDERMAL SYSTEM)
Patients should be counseled that this product does not protect against HIV
infection (AIDS) and other sexually transmitted diseases.
DESCRIPTION
ORTHO EVRA® is a combination transdermal contraceptive patch with a contact
surface ar... | custom-source | 2025-02-12T13:52:58.151224 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021180s035lbl.pdf', 'application_number': 21180, 'submission_type': 'SUPPL ', 'submission_number': 35} |
14,592 |
ORTHO EVRA®
(norelgestromin / ethinyl estradiol
TRANSDERMAL SYSTEM)
Patients should be counseled that this product does not protect against HIV
infection (AIDS) and other sexually transmitted diseases.
DESCRIPTION
ORTHO EVRA® is a combination transdermal contraceptive patch with a contact
surface area... | custom-source | 2025-02-12T13:52:58.208877 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s034lbl.pdf', 'application_number': 21180, 'submission_type': 'SUPPL ', 'submission_number': 34} |
14,595 |
ORTHO EVRA®
(norelgestromin / ethinyl estradiol
TRANSDERMAL SYSTEM)
WARNINGS: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING,
RISK OF VENOUS THROMBOEMBOLISM, AND PHARMACOKINETIC
PROFILE OF ETHINYL ESTRADIOL
Cigarette Smoking and Serious Cardiovascular Risks
Cigarette smoking increases ... | custom-source | 2025-02-12T13:52:58.581862 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021180s043lbl.pdf', 'application_number': 21180, 'submission_type': 'SUPPL ', 'submission_number': 43} |
14,594 |
ORTHO EVRA®
(norelgestromin / ethinyl estradiol
TRANSDERMAL SYSTEM)
WARNINGS: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING,
RISK OF VENOUS THROMBOEMBOLISM, AND PHARMACOKINETIC
PROFILE OF ETHINYL ESTRADIOL
Cigarette Smoking and Serious Cardiovascular Risks
Cigarette smoking increases the ... | custom-source | 2025-02-12T13:52:58.714846 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s040lbl.pdf', 'application_number': 21180, 'submission_type': 'SUPPL ', 'submission_number': 40} |
14,597 |
ApprovletS004.doc (clean copy 30Oct2001)
Page 3 of 34
VIDEX
EC (didanosine)
VIDEX EC (didanosine) Delayed-Release Capsules
Enteric-Coated Beadlets
(Patient Information Leaflet Included)
WARNING
FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING
THERAPY WITH DIDANOSINE USED ALONE OR IN C... | custom-source | 2025-02-12T13:52:58.929092 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21183s4lbl.pdf', 'application_number': 21183, 'submission_type': 'SUPPL ', 'submission_number': 4} |
14,596 |
... | custom-source | 2025-02-12T13:52:59.062901 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021180Orig1s046lbl.pdf', 'application_number': 21180, 'submission_type': 'SUPPL ', 'submission_number': 46} |
14,598 |
Page 4 of 34
VIDEX
EC (didanosine)
VIDEX EC (didanosine) Delayed-Release Capsules
Enteric-Coated Beadlets
(Patient Information Leaflet Included)
WARNING
FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING
THERAPY WITH DIDANOSINE USED ALONE OR IN COMBINATION
REGIMENS
IN
BOTH
TREATMENT-NAI... | custom-source | 2025-02-12T13:52:59.494419 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21183s5s6lbl.pdf', 'application_number': 21183, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,599 |
January 27, 2003
Page 4 of 70
VDXribaJan03FDA.doc (clean)
Rx only
VIDEX
(didanosine)
VIDEX (didanosine) Chewable/Dispersible Buffered Tablets
VIDEX (didanosine) Buffered Powder for Oral Solution
VIDEX (didanosine) Pediatric Powder for Oral Solution
(Patient Information Leaflet Included)
WARNING ... | custom-source | 2025-02-12T13:52:59.543365 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf', 'application_number': 21183, 'submission_type': 'SUPPL ', 'submission_number': 7} |
14,600 | NDA 20-154/S-050
NDA 20-155/S-039
NDA 20-156/S-040
NDA 21-183/S-016
Page 5 of 72
Rx only
VIDEX® (didanosine)
VIDEX® (didanosine) Pediatric Powder for Oral Solution
(Patient Information Leaflet Included)
WARNING
FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING
THERAPY WITH VIDEX USED ALONE OR IN... | custom-source | 2025-02-12T13:52:59.607595 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf', 'application_number': 21183, 'submission_type': 'SUPPL ', 'submission_number': 16} |
14,601 |
... | custom-source | 2025-02-12T13:52:59.806055 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021183s022lbl.pdf', 'application_number': 21183, 'submission_type': 'SUPPL ', 'submission_number': 22} |
14,603 |
... | custom-source | 2025-02-12T13:53:00.053607 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021183s025lbl.pdf', 'application_number': 21183, 'submission_type': 'SUPPL ', 'submission_number': 25} |
14,604 | 1
® Allergan, Inc.
TAZORAC® (tazarotene) Cream, 0.05%
TAZORAC® (tazarotene) Cream, 0.1%
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
DESCRIPTION
TAZORAC® Cream is a white cream and contains the compound tazarotene. Tazarotene is a
member of the acetylenic class of retinoids and is represented b... | custom-source | 2025-02-12T13:53:00.350318 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21184s1lbl.pdf', 'application_number': 21184, 'submission_type': 'SUPPL ', 'submission_number': 1} |
14,605 | ® Allergan, Inc.
AVAGE™ (tazarotene) Cream, 0.1%
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
DESCRIPTION
AVAGE™ Cream is a white cream and contains the compound tazarotene; this formulation of
tazarotene cream is also marketed for the treatment of plaque psoriasis and acne vulgaris as Tazorac®
... | custom-source | 2025-02-12T13:53:00.595475 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21184s2lbl.pdf', 'application_number': 21184, 'submission_type': 'SUPPL ', 'submission_number': 2} |
14,602 |
... | custom-source | 2025-02-12T13:53:00.616222 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021183s023lbl.pdf', 'application_number': 21183, 'submission_type': 'SUPPL ', 'submission_number': 23} |
14,606 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use... | custom-source | 2025-02-12T13:53:00.767215 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021184s007lbl.pdf', 'application_number': 21184, 'submission_type': 'SUPPL ', 'submission_number': 7} |
14,607 |
Women should be counseled that this product does not protect against HIV
infection (AIDS) and other sexually transmitted diseases.
FOR VAGINAL USE ONLY
DESCRIPTION
NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent,
colorless to almost colorles... | custom-source | 2025-02-12T13:53:01.001008 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021187s017lbl.pdf', 'application_number': 21187, 'submission_type': 'SUPPL ', 'submission_number': 17} |
14,608 |
... | custom-source | 2025-02-12T13:53:01.058525 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s022lbl.pdf', 'application_number': 21187, 'submission_type': 'SUPPL ', 'submission_number': 22} |
14,609 |
... | custom-source | 2025-02-12T13:53:01.259432 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s024lbl.pdf', 'application_number': 21187, 'submission_type': 'SUPPL ', 'submission_number': 24} |
14,610 |
Patient Information
NuvaRing® (NEW-vah-ring)
(etonogestrel/ethinyl estradiol vaginal ring)
What is the most important information I should know about
NuvaRing?
Do not ... | custom-source | 2025-02-12T13:53:01.338318 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s025lbl.pdf', 'application_number': 21187, 'submission_type': 'SUPPL ', 'submission_number': 25} |
14,612 | custom-source | 2025-02-12T13:53:01.390957 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol_Prntlbl.pdf', 'application_number': 21192, 'submission_type': 'ORIG ', 'submission_number': 1} | |
14,611 | NDA 21-191
Page 4
Division’s Revised Proposed Package Insert
Imagent®
Kit for the Preparation of Perflexane Lipid Microspheres Injectable Suspension
For Intravenous Administration
DESCRIPTION
Imagent® Kit for the preparation of perflexane lipid microspheres for injectable suspension,
is a sterile, non-... | custom-source | 2025-02-12T13:53:01.424980 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21191lbl.pdf', 'application_number': 21191, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,615 | PATIENT INFORMATION
LESCOL® [ lĕs-cŏl]
(fluvastatin sodium)
Capsules
and
LESCOL® [ lĕs-cŏl] XL
(fluvastatin sodium)
Extended-release tablets
Read the Patient Information that comes with
LESCOL or LESCOL XL before you start taking it,
and each time you get a refill. There may be new
information. Th... | custom-source | 2025-02-12T13:53:01.582846 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20261s034,21192s008lbl.pdf', 'application_number': 21192, 'submission_type': 'SUPPL ', 'submission_number': 8} |
14,613 | T2001-02
89011103
Lescol
®
(fluvastatin sodium)
Capsules
Lescol
® XL
(fluvastatin sodium)
Extended-Release Tablets
Rx only
Prescribing Information
DESCRIPTION
Lescol® (fluvastatin sodium), is a water-soluble cholesterol lowering agent which acts through the
inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) ... | custom-source | 2025-02-12T13:53:01.692383 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21192s2lbl.pdf', 'application_number': 21192, 'submission_type': 'SUPPL ', 'submission_number': 2} |
14,616 |
Lescol
®
(fluvastatin sodium)
Capsules
Lescol
® XL
(fluvastatin sodium)
Extended-Release Tablets
Rx only
Prescribing Information
DESCRIPTION
Lescol® (fluvastatin sodium), is a water-soluble cholesterol lowering agent which acts through
the inhibition of 3-hydroxy-3-methylglutaryl-coenz... | custom-source | 2025-02-12T13:53:01.816930 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf', 'application_number': 21192, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,617 |
Lescol
®
(fluvastatin sodium)
Capsules
Lescol
® XL
(fluvastatin sodium)
Extended-Release Tablets
Rx only
Prescribing Information
DESCRIPTION
Lescol® (fluvastatin sodium), is a water-soluble cholesterol lowering agent which acts through
the inhibition of 3-hydroxy-3-methylglutaryl-coenz... | custom-source | 2025-02-12T13:53:02.046339 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf', 'application_number': 21192, 'submission_type': 'SUPPL ', 'submission_number': 11} |
14,614 |
T2003340
89011106
Lescol
®
(fluvastatin sodium)
Capsules
Lescol
® XL
(fluvastatin sodium)
Extended-Release Tablets
Rx only
Prescribing Information
DESCRIPTION
Lescol® (fluvastatin sodium), is a water-soluble cholesterol lowering agent which acts through
the inhibition of 3-hydroxy-3-methylglut... | custom-source | 2025-02-12T13:53:02.053879 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20261se1-033,21192se1-005_lescol_lbl.pdf', 'application_number': 21192, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,618 | Xyrem® Risk Management Program
I.
As a condition of approval, the requirements of your Risk Management Program include the
following, with the details of the Program set out below in III.
• Implementation of a restricted distribution program for Xyrem
• Implementation of a program to educate physicians and patients ab... | custom-source | 2025-02-12T13:53:02.382370 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21196lbl.pdf', 'application_number': 21196, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,622 | Final Draft Cetrotide™ package insert: version 08/11/2000
Cetrotide™ (cetrorelix acetate for injection) 0.25 mg and 3 mg
FOR SUBCUTANEOUS USE ONLY
DESCRIPTION
Cetrotide™ (cetrorelix acetate for injection) is a synthetic decapeptide with gonadotropin-
releasing hormone (GnRH) antagonistic activity. Cetrorelix acetate i... | custom-source | 2025-02-12T13:53:02.521676 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21197lbl.pdf', 'application_number': 21197, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,620 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
Allow ... | custom-source | 2025-02-12T13:53:02.717818 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021196s013lbl.pdf', 'application_number': 21196, 'submission_type': 'SUPPL ', 'submission_number': 13} |
14,619 | NDA 21-196/S-005
Page 1
FDA Approved Labeling Text dated 11/18/05
Rx only
Xyrem® (sodium oxybate) oral solution
CIII
!WARNING: Central nervous system depressant with abuse potential.
Should not be used with alcohol or other CNS depressants.
Sodium oxybate is GHB, a known drug of abuse. Abuse has ... | custom-source | 2025-02-12T13:53:02.758833 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021196s005lbl.pdf', 'application_number': 21196, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,623 | NDA 21-199/S-004 & S-005
Page 3
1 mL carton and container label
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NDA 21-199/S-004 & S-005
Page 4
5 mL carton and container label
This label may not ... | custom-source | 2025-02-12T13:53:02.931226 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021199s004,005lbl.pdf', 'application_number': 21199, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,624 |
NDA 21199/S-014
Page 3
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information
needed to use QUIXIN® ophthalmic solution safely and
effectively. See full prescribing information for
QUIXIN®.
QUIXIN® (levofloxacin ophthalmic solution) 0.5%
Sterile topical ophthalmic solutio... | custom-source | 2025-02-12T13:53:03.034962 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021199s014lbl.pdf', 'application_number': 21199, 'submission_type': 'SUPPL ', 'submission_number': 14} |
14,626 | GLUCOPHAGE® /GLUCOPHAGE
XR
Page 1 of 29
Response to FDA Comments of 10 12 00.doc – CLEAN DRAFT 10 13 00
Rx only
GLUCOPHAGE
(metformin hydrochloride tablets)
GLUCOPHAGE
XR (metformin hydrochloride
extended-release tablets)
DESCRIPTION
GLUCOPHAGE®
(metformin
hydrochloride
tablets)
and
GLUCOPHAGE ... | custom-source | 2025-02-12T13:53:03.149778 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21202lbl.pdf', 'application_number': 21202, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,625 | NDA 21-200/S-014
Page 3
T2006-79/T2004-54
89015305
Zelnorm®
(tegaserod maleate)
Tablets
Rx only
Prescribing Information
DESCRIPTION
Zelnorm® (tegaserod maleate) tablets contain tegaserod as the hydrogen maleate salt. As the maleate
salt,
tegaserod
is
chemically
designated
as
3-(5-methoxy-1H-ind... | custom-source | 2025-02-12T13:53:03.221627 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021200s014lbl.pdf', 'application_number': 21200, 'submission_type': 'SUPPL ', 'submission_number': 14} |
14,627 | NDA 21-202/S-008
Page 3
Bristol-Myers Squibb Company
Rx only
GLUCOPHAGE
(metformin hydrochloride tablets)
GLUCOPHAGE
XR
(metformin hydrochloride extended-release tablets)
DESCRIPTION
GLUCOPHAGE®
(metformin
hydrochloride tablets) and GLUCOPHAGE XR (metformin
hydrochloride extended-rel... | custom-source | 2025-02-12T13:53:03.428665 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21202scf008_glucophage_lbl.pdf', 'application_number': 21202, 'submission_type': 'SUPPL ', 'submission_number': 8} |
14,628 |
NDA 20-357/S-031
NDA 21-202/S-016
Page 3 Bristol logo
GLUCOPHAGE®
(metformin hydrochloride tablets)
GLUCOPHAGE® XR
(metformin hydrochloride extended-release tablets)
DESCRIPTION
GLUCOPHAGE® (metformin hydrochloride tablets) and GLUCOPHAGE® XR (metformin
hydrochloride extended... | custom-source | 2025-02-12T13:53:03.573489 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020357s031,021202s016lbl.pdf', 'application_number': 21202, 'submission_type': 'SUPPL ', 'submission_number': 16} |
14,630 | NDA 21-204/S-006
Page 3
Starlix
(nateglinide) tablets
Rx only
DESCRIPTION
STARLIX® (NATEGLINIDE) IS AN ORAL ANTIDIABETIC AGENT USED IN THE MANAGEMENT OF TYPE 2 DIABETES
MELLITUS [ALSO KNOWN AS NON-INSULIN DEPENDENT DIABETES MELLITUS (NIDDM) OR ADULT-ONSET
DIABETES]. STARLIX, (-)-N-[(TRANS-4-ISOPROPYLCYCLOH... | custom-source | 2025-02-12T13:53:03.695545 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21204se1-006_starlix_lbl.pdf', 'application_number': 21204, 'submission_type': 'SUPPL ', 'submission_number': 6} |
14,629 |
... | custom-source | 2025-02-12T13:53:03.735267 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021203s005lbl.pdf', 'application_number': 21203, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,634 | 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 | 2025-02-12T13:53:03.901299 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020415s018,021208s009lbl.pdf', 'application_number': 21208, 'submission_type': 'SUPPL ', 'submission_number': 9} |
14,631 | Starlix ®
(nateglinide) tablets
Starlix ®
(nateglinide) tablets
Rx only
Prescribing Information
DESCRIPTION
Starlix® (nateglinide) is an oral antidiabetic agent used in the
management of Type 2 diabetes mellitus [also known as non-insulin
dependent diabetes mellitus (NIDDM) or adult-onset diabetes].
Starlix, (-)-N-[(tr... | custom-source | 2025-02-12T13:53:03.964098 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21204slr009_starlix_lbl.pdf', 'application_number': 21204, 'submission_type': 'SUPPL ', 'submission_number': 9} |
14,632 | PRESCRIBING INFORMATION
1
2
3
4
5
TRIZIVIR®
(abacavir sulfate, lamivudine, and zidovudine)
Tablets
WARNINGS
6
TRIZIVIR contains 3 nucleoside analogues (abacavir sulfate, lamivudine, and
7
zidovudine) and is intended only for patients whose regimen would otherwise include these
8
3 components.
9
1... | custom-source | 2025-02-12T13:53:04.139844 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021205s021lbl.pdf', 'application_number': 21205, 'submission_type': 'SUPPL ', 'submission_number': 21} |
14,633 | custom-source | 2025-02-12T13:53:04.156583 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-208_Remeron_prntlbl.pdf', 'application_number': 21208, 'submission_type': 'ORIG ', 'submission_number': 1} | |
14,636 |
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. Anyo... | custom-source | 2025-02-12T13:53:04.391740 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021208s020lbl.pdf', 'application_number': 21208, 'submission_type': 'SUPPL ', 'submission_number': 20} |
14,635 |
Drug name
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 considerin... | custom-source | 2025-02-12T13:53:04.737665 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021208s013s014lbl.pdf', 'application_number': 21208, 'submission_type': 'SUPPL ', 'submission_number': 13} |
14,639 | Unithroid (levothyroxine sodium tablets, USP)
Page 1
DESCRIPTION
---UNITHROID™ (levothyroxine sodium tablets, USP) contain synthetic crystalline L-3,3’,5,5’-tetraiodothyronine
sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland.
Levothyroxine (T4) sodium has a... | custom-source | 2025-02-12T13:53:04.750268 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21210lbl.pdf', 'application_number': 21210, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,637 |
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... | custom-source | 2025-02-12T13:53:04.891861 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021208s022lbl.pdf', 'application_number': 21208, 'submission_type': 'SUPPL ', 'submission_number': 22} |
14,643 |
__________________________________________________________________________________________________________________________
_______________________________________________________________________________... | custom-source | 2025-02-12T13:53:05.439314 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021214s006s007lbl.pdf', 'application_number': 21214, 'submission_type': 'SUPPL ', 'submission_number': 7} |
14,640 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These hi... | custom-source | 2025-02-12T13:53:05.445266 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021211s011lbl.pdf', 'application_number': 21211, 'submission_type': 'SUPPL ', 'submission_number': 11} |
14,641 | CaverJect Impulse®
Dual Chamber System
alprostadil for injection
For Intracavernosal Use
DESCRIPTION
CAVERJECT contains alprostadil as the naturally occurring form of prostaglandin E1
(PGE1) and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13
en-1-oic acid. The molecular weight is 354.49.... | custom-source | 2025-02-12T13:53:05.556072 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021212s007lbl.pdf', 'application_number': 21212, 'submission_type': 'SUPPL ', 'submission_number': 7} |
14,642 |
... | custom-source | 2025-02-12T13:53:05.621936 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021212s014lbl.pdf', 'application_number': 21212, 'submission_type': 'SUPPL ', 'submission_number': 14} |
14,644 | NDA 21-216, NDA 20-235/S-015, NDA 20-882/S-002, NDA 21-129/S-005
Page 1
FDA approved labeling text (dated 10/12/00)
Neurontin® (gabapentin) capsules,
Neurontin® (gabapentin) tablets
Neurontin® (gabapentin) oral solution
DESCRIPTION
Neurontin® (gabapentin) capsules, Neurontin® (gabapentin) tablets, and Neurontin®
(gabap... | custom-source | 2025-02-12T13:53:05.756535 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21216lbl.pdf', 'application_number': 21216, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,645 |
_______________
_____________
___________
____________
__________________
_________________
______________
_____________
... | custom-source | 2025-02-12T13:53:06.050036 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021217s004lbl.pdf', 'application_number': 21217, 'submission_type': 'SUPPL ', 'submission_number': 4} |
14,648 | SPECTRACEF
Tablets
(cefditoren pivoxil)
RX ONLY
DESCRIPTION
SPECTRACEF tablets contain cefditoren pivoxil, a semi-synthetic cephalosporin antibiotic for oral
administration. It is a prodrug which is hydrolyzed by esterases during absorption, and the drug is
distributed in the circulating blood as active cefdito... | custom-source | 2025-02-12T13:53:06.417944 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21222lbl.pdf', 'application_number': 21222, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,647 |
_______________
__________... | custom-source | 2025-02-12T13:53:06.674132 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021217Orig1s012lbl.pdf', 'application_number': 21217, 'submission_type': 'SUPPL ', 'submission_number': 12} |
14,649 |
SPECTRACEF
TABLETS
(cefditoren pivoxil)
RX ONLY
DESCRIPTION
SPECTRACEF tablets contain cefditoren pivoxil, a semi-synthetic cephalosporin antibiotic for oral
administration. It is a prodrug which is hydrolyzed by esterases during absorption, and the drug is
distributed in the circulating bl... | custom-source | 2025-02-12T13:53:06.729174 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21222s1lbl.pdf', 'application_number': 21222, 'submission_type': 'SUPPL ', 'submission_number': 1} |
14,646 |
_______________
_____________
____________... | custom-source | 2025-02-12T13:53:06.887010 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021217s009lbl.pdf', 'application_number': 21217, 'submission_type': 'SUPPL ', 'submission_number': 9} |
14,650 |
SPECTRACEF® (cefditoren pivoxil) Tablets 200 and 400 mg.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of SPECTRACEF® and other antibacterial
drugs, SPECTRACEF® should be used only to treat infect... | custom-source | 2025-02-12T13:53:07.020650 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021222s012lbl.pdf', 'application_number': 21222, 'submission_type': 'SUPPL ', 'submission_number': 12} |
14,651 |
... | custom-source | 2025-02-12T13:53:07.037281 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021222s013s016lbl.pdf', 'application_number': 21222, 'submission_type': 'SUPPL ', 'submission_number': 13} |
14,652 | Zometa®(zoledronic acid for injection)
For Intravenous Infusion
Rx only
Prescribing Information
DESCRIPTION
Zometa® contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption.
Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic aci... | custom-source | 2025-02-12T13:53:07.309407 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21386lbl.pdf', 'application_number': 21223, 'submission_type': 'SUPPL ', 'submission_number': 3} |
14,654 | Zometa®
(zoledronic acid) Injection
Concentrate for Intravenous Infusion
Rx only
Prescribing Information
DESCRIPTION
Zometa® contains zoledronic acid, a bisphosphonic acid which is an inhibitor of
osteoclastic bone resorption. Zoledronic acid is designated chemically as
(1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phos... | custom-source | 2025-02-12T13:53:07.651815 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21223slr008_zometa_lbl.pdf', 'application_number': 21223, 'submission_type': 'SUPPL ', 'submission_number': 8} |
14,655 | Zometa®
(zoledronic acid) Injection
Concentrate for Intravenous Infusion
Rx only
Prescribing Information
DESCRIPTION
Zometa® contains zoledronic acid, a bisphosphonic acid which is an inhibitor of
osteoclastic bone resorption. Zoledronic acid is designated chemically as
(1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) pho... | custom-source | 2025-02-12T13:53:07.742521 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021223s009,010lbl.pdf', 'application_number': 21223, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,656 | Zometa®
(zoledronic acid) Injection
Concentrate for Intravenous Infusion
Rx only
Prescribing Information
DESCRIPTION
Zometa® contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone
resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl)
phosp... | custom-source | 2025-02-12T13:53:08.202716 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021223s011lbl.pdf', 'application_number': 21223, 'submission_type': 'SUPPL ', 'submission_number': 11} |
14,653 | Edited version without references (30-Oct-2002)
T2002-xx
xxxxxxxxx
Zometa®
(zoledronic acid ) Injection
Concentrate for Intravenous Infusion
Rx only
Prescribing Information
DESCRIPTION
Zometa® contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic
bone resorption. Zoledronic ... | custom-source | 2025-02-12T13:53:08.203479 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21223scf004_zometa_lbl.pdf', 'application_number': 21223, 'submission_type': 'SUPPL ', 'submission_number': 4} |
14,658 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Zometa
safely and effectively. See full prescribing information for Zometa.
Zometa® (zoledronic acid) Injection
Concentrate for Intravenous Infusion
Initial U.S. Approval: 2001
--------------INDICATIONS AND U... | custom-source | 2025-02-12T13:53:08.638035 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021223s016lbl.pdf', 'application_number': 21223, 'submission_type': 'SUPPL ', 'submission_number': 16} |
14,657 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Zometa
safely and effectively. See full prescribing information for Zometa.
Zometa® (zoledronic acid) Injection
Concentrate for Intravenous Infusion
Initial U.S. Approval: 2001
--------------INDICATIONS AND U... | custom-source | 2025-02-12T13:53:08.692019 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021223s014lbl.pdf', 'application_number': 21223, 'submission_type': 'SUPPL ', 'submission_number': 14} |
14,659 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Zometa
sa... | custom-source | 2025-02-12T13:53:09.035565 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021223s018lbl.pdf', 'application_number': 21223, 'submission_type': 'SUPPL ', 'submission_number': 18} |
14,660 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZOMETA safely and effectively. See full prescribing information for
ZOMETA.
ZOMETA® (zoledronic acid) Injection
Ready-to-Use Solution for Intravenous Infusion (For Single Use)
Concentrate for Intravenous Infu... | custom-source | 2025-02-12T13:53:09.075071 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021223s028lbl.pdf', 'application_number': 21223, 'submission_type': 'SUPPL ', 'submission_number': 28} |
14,661 |
... | custom-source | 2025-02-12T13:53:09.664001 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021223s031lbl.pdf', 'application_number': 21223, 'submission_type': 'SUPPL ', 'submission_number': 31} |
14,663 |
str
u
ct
ur
a
l
form
ula
NDA 21-169/S 016
NDA 21-224/S-014
NDA 21-615/S-008
RAZADYNE® ER
galantamine HBr
Extended-Release Capsules
RAZADYNE®
galantamine HBr
Tablets and Oral Solution
DESCRIPTION
RAZADYNE® ER/RAZADYNE® (galantamine hydrobromide) is galantamine hydrobromide, a
reversi... | custom-source | 2025-02-12T13:53:09.722505 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s016,021224s014,021615s008lbl.pdf', 'application_number': 21224, 'submission_type': 'SUPPL ', 'submission_number': 14} |
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