id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
11,620 | 1
PRESCRIBING INFORMATION
1
ZANTAC® 150
2
(ranitidine hydrochloride)
3
Tablets, USP
4
5
ZANTAC® 300
6
(ranitidine hydrochloride)
7
Tablets, USP
8
9
ZANTAC® 25
10
(ranitidine hydrochloride effervescent)
11
EFFERdose® Tablets
12
13
ZANTAC® 150
14
(ranitidine hydrochloride effervescen... | custom-source | 2025-02-12T13:45:41.240189 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018703s065,019675s031,020251s016lbl.pdf', 'application_number': 19675, 'submission_type': 'SUPPL ', 'submission_number': 31} |
11,623 | Nutropin [somatropin (rDNA origin) for injection]
Nutropin Genentech, Inc.
November 2004
1
Clean Package Insert
Nutropin
[somatropin (rDNA origin) for injection]
DESCRIPTION
Nutropin is a human growth hormone (hGH) produced by recombinant DNA technology.
Nutropin has 191 amino acid residues and a molecu... | custom-source | 2025-02-12T13:45:41.565516 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf', 'application_number': 19676, 'submission_type': 'SUPPL ', 'submission_number': 21} |
11,624 | NDA 19-677/S-005
NDA 19-678/S-005
Page 3
ENLON-PLUS (edrophonium chloride, USP and atropine sulfate, USP)
Injection
Rx only
DESCRIPTION
ENLON-PLUS (edrophonium chloride, USP and atropine sulfate, USP) Injection, for intravenous use,
is a sterile, nonpyrogenic, nondepolarizing neuromuscular relaxant antagonist... | custom-source | 2025-02-12T13:45:41.797209 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019677s005,019678s005lbl.pdf', 'application_number': 19677, 'submission_type': 'SUPPL ', 'submission_number': 5} |
11,625 | &N.LØNl~Pl.iUS~ (edrøphøni.um IChrøric:è~USPand
atropi'ne$Ulfete,USPlI111lction
R):Obly
"~fì:STOPPEReQNT.AINS LATEX.
DeSORIPTION .
ENI;;ON~:pDtJSeedröflhoniUmclitotidø, USParò atrQpine sUlfate, USP)
IiJectìoti, for
intravel1ous1:Se,is a steri1e,nOl1PYtögêl1iq,nonqep.Qlarizingneuroun.lscular l'ølaxart
a.l1tagonì... | custom-source | 2025-02-12T13:45:42.017449 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019677s006lbl.pdf', 'application_number': 19677, 'submission_type': 'SUPPL ', 'submission_number': 6} |
11,619 | Reference ID: 3852122
(b) (4)
(b)
(4)
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Reference ID: 3852122
(b) (4)
(b) (4)
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.f... | custom-source | 2025-02-12T13:45:42.344468 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019670Orig1s032, 020470Orig1s044lbl.pdf', 'application_number': 19670, 'submission_type': 'SUPPL ', 'submission_number': 32} |
11,628 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the informati... | custom-source | 2025-02-12T13:45:43.156269 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019680s026lbl.pdf', 'application_number': 19680, 'submission_type': 'SUPPL ', 'submission_number': 26} |
11,629 | NDA 019680/S-025/S-027/S-029/S-031
Depakote (divalproex sodium) Capsule for Oral use
FDA Approved Labeling Text dated October 7, 2011
Page 1 of 50
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Depakote safely and effectively. See full prescribing informa... | custom-source | 2025-02-12T13:45:43.558713 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf', 'application_number': 19680, 'submission_type': 'SUPPL ', 'submission_number': 27} |
11,626 |
DEPACON®
(No. 1564)
NEW
NDA 20-593/S-011
DEPACON®
VALPROATE SODIUM INJECTION
R× only
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 YEARS ARE... | custom-source | 2025-02-12T13:45:43.560647 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf', 'application_number': 19680, 'submission_type': 'SUPPL ', 'submission_number': 19} |
11,630 |
... | custom-source | 2025-02-12T13:45:44.187274 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s028lbl.pdf', 'application_number': 19680, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,627 | 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 | 2025-02-12T13:45:44.246782 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf', 'application_number': 19680, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,631 | NDA 019680/S-025/S-027/S-029/S-031
Depakote (divalproex sodium) Capsule for Oral use
FDA Approved Labeling Text dated October 7, 2011
Page 1 of 50
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Depakote safely and effectively. See full prescribing informa... | custom-source | 2025-02-12T13:45:44.403221 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf', 'application_number': 19680, 'submission_type': 'SUPPL ', 'submission_number': 29} |
11,632 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Depakote safely and effectively. See full prescribing information for
Depakote.
Depakote Sprinkle Capsules (divalproex sodium coated particles in
capsules), for oral use
Initial U.S. Approval: 1989
WARNING: L... | custom-source | 2025-02-12T13:45:44.558406 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s034lblupdated.pdf', 'application_number': 19680, 'submission_type': 'SUPPL ', 'submission_number': 34} |
11,635 |
EN-0693
Page 1 of 12
AMINOSYN® II with ELECTROLYTES
in Dextrose Injection with Calcium
AN AMINO ACID INJECTION WITH ELECTROLYTES IN DEXTROSE
INJECTION WITH CALCIUM
NOTE: These solutions are hypertonic. See WARNINGS and PRECAUTIONS.
Nutrimix® Dual-chamber Flexible Container
The Upper Chamber Contains 500 mL ... | custom-source | 2025-02-12T13:45:44.874037 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019683s027lbl.pdf', 'application_number': 19683, 'submission_type': 'SUPPL ', 'submission_number': 27} |
11,633 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Depakote safely and effectively. See full prescribing information for
Depakote.
Depakote Sprinkle Capsules (divalproex sodium coated particles in
capsules), for oral use
Initial U.S. Approval: 1989
WARNING... | custom-source | 2025-02-12T13:45:45.156540 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s036lbl.pdf', 'application_number': 19680, 'submission_type': 'SUPPL ', 'submission_number': 36} |
11,636 |
s
t
r
uc
tur
a
l fo
rmula
PROCARDIA XL®
(nifedipine)
Extended Release Tablets
For Oral Use
DESCRIPTION
Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium
channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid,... | custom-source | 2025-02-12T13:45:45.299732 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019684s029lbl.pdf', 'application_number': 19684, 'submission_type': 'SUPPL ', 'submission_number': 29} |
11,638 |
10305001
barcode
barcode
ORTHO TRI-CYCLEN® TABLETS
ORTHO-CYCLEN® TABLETS
(norgestimate/ethinyl estradiol)
Patients should be counseled that this product does
not protect against HIV infection (AIDS) and other
sexually transmitted diseases.
barcode
DESCRIPTION
Each of the following products is ... | custom-source | 2025-02-12T13:45:45.912958 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019653s048lbl.pdf', 'application_number': 19697, 'submission_type': 'SUPPL ', 'submission_number': 44} |
11,637 | 1
ORTHO TRI-CYCLEN TABLETS (norgestimate/ethinyl estradiol)
and ORTHO-CYCLEN TABLETS (norgestimate/ethinyl estradiol)
WARNINGS: CARDIOVASCULAR RISK ASSOCIATED WITH
SMOKING
Cigarette smoking increases the risk of serious cardiovascular events from
combination oral contraceptive use. This risk increases with ... | custom-source | 2025-02-12T13:45:46.151676 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019653Orig1s046, 019697Orig1s042lbl.pdf', 'application_number': 19697, 'submission_type': 'SUPPL ', 'submission_number': 42} |
11,639 | 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 | 2025-02-12T13:45:46.191365 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19700s18lbl.pdf', 'application_number': 19700, 'submission_type': 'SUPPL ', 'submission_number': 18} |
11,634 |
... | custom-source | 2025-02-12T13:45:46.284041 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf', 'application_number': 19680, 'submission_type': 'SUPPL ', 'submission_number': 39} |
11,640 | NDA 19-700/S-023 & S-024
Page 3
ALLERGAN
ACULAR (ketorolac tromethamine ophthalmic solution) 0.5%
sterile
DESCRIPTION
ACULAR (ketorolac tromethamine ophthalmic solution) is a member of the pyrrolo-pyrrole group of
nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical nam... | custom-source | 2025-02-12T13:45:46.402704 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19700S023,024lbl.pdf', 'application_number': 19700, 'submission_type': 'SUPPL ', 'submission_number': 23} |
11,641 |
______________________________________________________________________________________________
... | custom-source | 2025-02-12T13:45:46.435857 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019700s028lbl.pdf', 'application_number': 19700, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,642 | NDA 19-708/S-013
Page 3
0.15% Potassium Chloride in 0.9% Sodium Chloride Injection
DESCRIPTION
Rx only
Each 100 mL of 0.15% Potassium Chloride in 0.9% Sodium Chloride Injection (20 mEq K+/liter)
contains: Sodium Chloride USP 0.9 g
Potassium Chloride USP 0.15 g; Water for Injection USP qs
pH may... | custom-source | 2025-02-12T13:45:46.558402 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19708s013lbl.pdf', 'application_number': 19708, 'submission_type': 'SUPPL ', 'submission_number': 13} |
11,644 | 19716/S-0221
DIPROLENE®
Brand of augmented betamethasone dipropionate*
Lotion 0.05% (potency expressed as betamethasone)
* Vehicle augments the penetration of the steroid.
For Dermatologic Use Only
Not for Ophthalmic Use
DESCRIPTION DIPROLENE® (augmented betamethason... | custom-source | 2025-02-12T13:45:46.731353 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019716s022lbl.pdf', 'application_number': 19716, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,645 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
DIPROLENE Lotion safely and effectively. See full prescribing
information for DIPROLENE Lotion.
DIPROLENE® (augmented betamethasone dipropionate) Lo... | custom-source | 2025-02-12T13:45:46.798142 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019716s030lbl.pdf', 'application_number': 19716, 'submission_type': 'SUPPL ', 'submission_number': 30} |
11,643 |
May 2015 ... | custom-source | 2025-02-12T13:45:46.875766 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019710s052,020923s018lbl.pdf', 'application_number': 19710, 'submission_type': 'SUPPL ', 'submission_number': 52} |
11,652 | DESCRIPTION
Cyanocobalamin is a synthetic form of vitamin B12 with equivalent vitamin B12 activity. The chemical name is 5,6-dimethyl-
benzimidazolyl cyanocobamide. The cobalt content is 4.35%. The molecular formula is C63H88CoN14O14P, which corresponds
to a molecular weight of 1355.38 and the following structural form... | custom-source | 2025-02-12T13:45:46.950860 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19722slr006_nascobal_lbl.pdf', 'application_number': 19722, 'submission_type': 'SUPPL ', 'submission_number': 6} |
11,654 |
_______________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:45:47.232316 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf', 'application_number': 19726, 'submission_type': 'SUPPL ', 'submission_number': 51} |
11,653 |
_______________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:45:47.344901 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf', 'application_number': 19726, 'submission_type': 'SUPPL ', 'submission_number': 50} |
11,656 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZOLADEX safely and effectively. See full prescribing information for
ZOLADEX.
ZOLADEX (goserelin acetate implant) 3.6 mg
Initial U.S. Approval: 1989
---------------------------INDICATIONS AND USAGE--------... | custom-source | 2025-02-12T13:45:47.616882 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019726s056,019726s057lbl.pdf', 'application_number': 19726, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,655 |
NDA 019726/S-054
Zoladex (goserelin acetate
implant) 3.6 mg
Reference ID: 2888048
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
... | custom-source | 2025-02-12T13:45:47.628359 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019726s054lbl.pdf', 'application_number': 19726, 'submission_type': 'SUPPL ', 'submission_number': 54} |
11,657 |
... | custom-source | 2025-02-12T13:45:48.162728 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019726s059,020578s037lbl.pdf', 'application_number': 19726, 'submission_type': 'SUPPL ', 'submission_number': 59} |
11,661 |
NDA 019732/S-037
Lupron Depot 7.5 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 - leuprolide ... | custom-source | 2025-02-12T13:45:48.320888 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019732s037lbl.pdf', 'application_number': 19732, 'submission_type': 'SUPPL ', 'submission_number': 37} |
11,659 | 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 | 2025-02-12T13:45:48.544438 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf', 'application_number': 19732, 'submission_type': 'SUPPL ', 'submission_number': 31} |
11,660 | 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 | 2025-02-12T13:45:48.567783 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf', 'application_number': 19732, 'submission_type': 'SUPPL ', 'submission_number': 36} |
11,662 |
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 the natural hormone. The chemical name is 5
oxo-L-prolyl... | custom-source | 2025-02-12T13:45:48.750933 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019732s038lbl.pdf', 'application_number': 19732, 'submission_type': 'SUPPL ', 'submission_number': 38} |
11,664 |
... | custom-source | 2025-02-12T13:45:49.221861 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019732s042,020517s038lbl.pdf', 'application_number': 19732, 'submission_type': 'SUPPL ', 'submission_number': 42} |
11,663 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
LUPRON DEPOT safely and effectively. See full prescribing information
for LUPRON DEPOT.
LUPRON DEPOT (leuprolide acetate for depot suspension)
Initial U.S. Approval: 1989
-----------------------------RECENT... | custom-source | 2025-02-12T13:45:49.310805 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020517s036_019732s041lbl.pdf', 'application_number': 19732, 'submission_type': 'SUPPL ', 'submission_number': 41} |
11,665 |
__________________
___________________
___________________
_______________________
_______________________ ... | custom-source | 2025-02-12T13:45:49.315919 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019734s023lbl.pdf', 'application_number': 19734, 'submission_type': 'SUPPL ', 'submission_number': 23} |
11,668 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
| custom-source | 2025-02-12T13:45:49.620409 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19757S10lbl.pdf', 'application_number': 19757, 'submission_type': 'SUPPL ', 'submission_number': 10} |
11,666 | FLOXIN® TABLETS
(ofloxacin tablets)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
FLOXIN (ofloxacin tablets) Tablets and other antibacterial drugs, FLOXIN
(ofloxacin tablets) Tablets should be used only to treat or prevent infections that are
proven or strongly suspecte... | custom-source | 2025-02-12T13:45:49.692435 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019735s054LBL.pdf', 'application_number': 19735, 'submission_type': 'SUPPL ', 'submission_number': 54} |
11,667 |
1
FLOXIN® Tablets
(ofloxacin tablets)
To reduce the development of drug-resistant bacteria and maintain the effectiveness
of FLOXIN® (ofloxacin tablets) Tablets and other antibacterial drugs, FLOXIN®
(ofloxacin tablets) Tablets should be used only to treat or prevent infections that are
proven or strongly suspe... | custom-source | 2025-02-12T13:45:49.859211 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019735s056lbl.pdf', 'application_number': 19735, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,670 |
T2004-73
CLOZARIL®
(clozapine) Tablets
Rx only
Prescribing Information
Before prescribing CLOZARIL® (clozapine), the physician should be thoroughly familiar with
the details of this prescribing information.
WARNING
1.
AGRANULOCYTOSIS
BECAUSE
OF
A
SIGNIFICANT
RISK
OF
AGRANULOCYTOSIS,
A
POTENTIALLY LI... | custom-source | 2025-02-12T13:45:50.032432 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019758s054lbl.pdf', 'application_number': 19758, 'submission_type': 'SUPPL ', 'submission_number': 54} |
11,671 |
T2004-73
CLOZARIL®
(clozapine) Tablets
Rx only
Prescribing Information
Before prescribing CLOZARIL® (clozapine), the physician should be thoroughly familiar with
the details of this prescribing information.
WARNING
1.
AGRANULOCYTOSIS
BECAUSE
OF
A
SIGNIFICANT
RISK
OF
AGRANULOCYTOSIS,
A
POTENTIALLY LI... | custom-source | 2025-02-12T13:45:50.262972 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019758s056lbl.pdf', 'application_number': 19758, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,673 |
Company logo
CLOZARIL®
(clozapine) Tablets
Rx only
Prescribing Information
Before prescribing CLOZARIL® (clozapine), the physician should be thoroughly familiar with
the details of this prescribing information.
BOXED WARNING
1.
AGRANULOCYTOSIS
BECAUSE OF A SIGNIFICANT RISK OF AGRAN... | custom-source | 2025-02-12T13:45:50.611188 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019758s062lbl.pdf', 'application_number': 19758, 'submission_type': 'SUPPL ', 'submission_number': 62} |
11,669 | 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 | 2025-02-12T13:45:50.720639 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19758s44lbl.pdf', 'application_number': 19758, 'submission_type': 'SUPPL ', 'submission_number': 44} |
11,672 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not inclu... | custom-source | 2025-02-12T13:45:50.834437 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s061s077lbl.pdf', 'application_number': 19758, 'submission_type': 'SUPPL ', 'submission_number': 61} |
11,674 |
c
ompany logo
CLOZARIL®
(clozapine) Tablets
Rx only
Prescribing Information
Before prescribing CLOZARIL® (clozapine), the physician should be thoroughly familiar with
the details of this prescribing information.
BOXED WARNING
1.
AGRANULOCYTOSIS
BECAUSE OF A SIGNIFICANT RISK OF AGRAN... | custom-source | 2025-02-12T13:45:51.020128 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019758s063lbl.pdf', 'application_number': 19758, 'submission_type': 'SUPPL ', 'submission_number': 63} |
11,675 |
CLOZARIL®
(clozapine) Tablets
Rx only
Prescribing Information
Before prescribing CLOZARIL® (clozapine), the physician should be thoroughly familiar with
the details of this prescribing information.
BOXED WARNING
1.
AGRANULOCYTOSIS
BECAUSE OF A SIGNIFICANT RISK OF AGRANULOCYTOSIS, A POTENTIALLY
LIFE-TH... | custom-source | 2025-02-12T13:45:51.563978 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf', 'application_number': 19758, 'submission_type': 'SUPPL ', 'submission_number': 68} |
11,678 | SAIZEN® [somatropin (rDNA origin) for injection], NDA 19-764/S-020
DRAFT PACKAGE INSERT: Adult Growth Hormone Deficiency (Submitted 10.26.04)
Saizen®
[somatropin (rDNA origin) for injection]
For subcutaneous or intramuscular injection
DESCRIPTION
Saizen® [somatropin (rDNA origin) for injection]... | custom-source | 2025-02-12T13:45:51.703011 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764s020lbl.pdf', 'application_number': 19764, 'submission_type': 'SUPPL ', 'submission_number': 20} |
11,677 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not inclu... | custom-source | 2025-02-12T13:45:51.777585 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s061s077lbl.pdf', 'application_number': 19758, 'submission_type': 'SUPPL ', 'submission_number': 77} |
11,676 |
... | custom-source | 2025-02-12T13:45:51.831399 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019758s073lbl.pdf', 'application_number': 19758, 'submission_type': 'SUPPL ', 'submission_number': 73} |
11,679 |
Saizen®
[somatropin (rDNA origin) for injection]
For subcutaneous or intramuscular injection
DESCRIPTION
Saizen® [somatropin (rDNA origin) for injection] is a human growth hormone produced
by recombinant DNA technology. Saizen® has 191 amino acid residues and a molecular
weight of 22,125 daltons. Its am... | custom-source | 2025-02-12T13:45:52.415358 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s030lbl.pdf', 'application_number': 19764, 'submission_type': 'SUPPL ', 'submission_number': 30} |
11,682 | Batch No:
Exp. Date:
Batch No:
Expiry Date:
L1280101C
Lot No:
Exp. Date:
Saizen® 8.8 mg click.easy®
[somatropin (rDNA origin) for injection]
(approximately 26.4 IU), approximately 5.83 mg/mL
of drug is delivered
Manufactured for: EMD Serono, Inc., Rockland, MA 02370, USA
s.c.
03/07
EMD Serono, Inc.
This label may not ... | custom-source | 2025-02-12T13:45:52.417764 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s039lbl.pdf', 'application_number': 19764, 'submission_type': 'SUPPL ', 'submission_number': 39} |
11,680 |
Saizen®
[somatropin (rDNA origin) for injection]
For subcutaneous or intramuscular injection
DESCRIPTION
Saizen® [somatropin (rDNA origin) for injection] is a human growth hormone produced by
recombinant DNA technology. Saizen® has 191 amino acid residues and a molecular weight of
22,125 daltons. Its amin... | custom-source | 2025-02-12T13:45:52.451031 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s034lbl.pdf', 'application_number': 19764, 'submission_type': 'SUPPL ', 'submission_number': 34} |
11,681 |
Saizen®
[somatropin (rDNA origin) for injection]
For subcutaneous or intramuscular injection
DESCRIPTION
Saizen® [somatropin (rDNA origin) for injection] is a human growth hormone produced by
recombinant DNA technology. Saizen® has 191 amino acid residues and a molecular weight of
22,125 daltons. Its amin... | custom-source | 2025-02-12T13:45:52.842782 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s035lbl.pdf', 'application_number': 19764, 'submission_type': 'SUPPL ', 'submission_number': 35} |
11,683 | 7825441
TABLETS
ZOCOR®
(SIMVASTATIN)
DESCRIPTION
ZOCOR* (simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation product
of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the
corresponding β-hydroxyacid form. This is an inhibitor o... | custom-source | 2025-02-12T13:45:53.030871 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19766s45s53lbl.pdf', 'application_number': 19766, 'submission_type': 'SUPPL ', 'submission_number': 53} |
11,685 | 9556643
TABLETS
ZOCOR®
(SIMVASTATIN)
DESCRIPTION
ZOCOR
1 (simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation product
of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the
corresponding β-hydroxyacid form. This is an inhibitor ... | custom-source | 2025-02-12T13:45:53.046197 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastatin_lbl.pdf', 'application_number': 19766, 'submission_type': 'SUPPL ', 'submission_number': 65} |
11,684 | 782544X
TABLETS
ZOCOR®
(SIMVASTATIN)
DESCRIPTION
ZOCOR
1 (simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation product
of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the
corresponding β-hydroxyacid form. This is an inhibitor ... | custom-source | 2025-02-12T13:45:53.253202 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766se1-058_zocor_lbl.pdf', 'application_number': 19766, 'submission_type': 'SUPPL ', 'submission_number': 58} |
11,686 | 9556643
TABLETS
ZOCOR®
(SIMVASTATIN)
DESCRIPTION
ZOCOR
1 (simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation product
of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the
corresponding β-hydroxyacid form. This is an inhibitor ... | custom-source | 2025-02-12T13:45:53.327596 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastatin_lbl.pdf', 'application_number': 19766, 'submission_type': 'SUPPL ', 'submission_number': 66} |
11,688 |
955664495566XX
TABLETS
ZOCOR®
(SIMVASTATIN)
DESCRIPTION
ZOCOR1 (simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation product
of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the
corresponding β-hydroxyacid form. Th... | custom-source | 2025-02-12T13:45:53.534346 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.pdf', 'application_number': 19766, 'submission_type': 'SUPPL ', 'submission_number': 68} |
11,689 |
9556648XXXXXXX
TABLETS
ZOCOR®
(SIMVASTATIN)
DESCRIPTION
ZOCOR1 (simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation
product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed
to the corresponding β-hydroxyacid form. Th... | custom-source | 2025-02-12T13:45:53.746847 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s069lbl.pdf', 'application_number': 19766, 'submission_type': 'SUPPL ', 'submission_number': 69} |
11,687 |
955664495566XX
TABLETS
ZOCOR®
(SIMVASTATIN)
DESCRIPTION
ZOCOR1 (simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation product
of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the
corresponding β-hydroxyacid form. Th... | custom-source | 2025-02-12T13:45:53.754668 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.pdf', 'application_number': 19766, 'submission_type': 'SUPPL ', 'submission_number': 67} |
11,690 |
9556651
TABLETS
ZOCOR®
(SIMVASTATIN)
DESCRIPTION
ZOCOR1 (simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation
product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed
to the corresponding β-hydroxyacid form. This is a... | custom-source | 2025-02-12T13:45:53.855497 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s075lbl.pdf', 'application_number': 19766, 'submission_type': 'SUPPL ', 'submission_number': 75} |
11,691 |
Merck Logo
9876252
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZOCOR safely and effectively. See full prescribing information for
ZOCOR.
ZOCOR (simvastat... | custom-source | 2025-02-12T13:45:53.989430 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019766s076lbl.pdf', 'application_number': 19766, 'submission_type': 'SUPPL ', 'submission_number': 76} |
11,693 |
Company logo
9876254
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZOCOR safely and effectively. See full prescribing information for
ZOCOR.
ZOCOR (simv... | custom-source | 2025-02-12T13:45:54.226532 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s080lbl.pdf', 'application_number': 19766, 'submission_type': 'SUPPL ', 'submission_number': 80} |
11,694 |
company logo
9992858
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZOCOR safely and effectively. See full prescribing information for
ZOCOR.
ZOCOR (si... | custom-source | 2025-02-12T13:45:54.527339 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s085lbl.pdf', 'application_number': 19766, 'submission_type': 'SUPPL ', 'submission_number': 85} |
11,692 |
Company logo
9876253
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZOCOR safely and effectively. See full prescribing information for
ZOCOR.
ZOCOR... | custom-source | 2025-02-12T13:45:54.539295 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s078lbl.pdf', 'application_number': 19766, 'submission_type': 'SUPPL ', 'submission_number': 78} |
11,695 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZOCOR safely and effectively. See full prescribing information for
ZOCOR.
ZOCOR (simvastatin) Tablets
Initi... | custom-source | 2025-02-12T13:45:54.582698 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf', 'application_number': 19766, 'submission_type': 'SUPPL ', 'submission_number': 88} |
11,696 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZOCOR safely and effectively. See full prescribing information for
ZOCOR.
ZOCOR (simvastatin) Tablets
I... | custom-source | 2025-02-12T13:45:54.741440 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019766s090lbl.pdf', 'application_number': 19766, 'submission_type': 'SUPPL ', 'submission_number': 90} |
11,702 | ZESTRIL (Lisinopril)
ZESTRIL
(lisinopril)
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can
cause injury and even death to the developing fetus. When pregnancy is detected, ZESTRIL
should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity a... | custom-source | 2025-02-12T13:45:54.893680 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019777s054lbl.pdf', 'application_number': 19777, 'submission_type': 'SUPPL ', 'submission_number': 54} |
11,697 |
... | custom-source | 2025-02-12T13:45:55.098498 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019766s091lbl.pdf', 'application_number': 19766, 'submission_type': 'SUPPL ', 'submission_number': 91} |
11,698 |
... | custom-source | 2025-02-12T13:45:55.213907 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019766s093lbl.pdf', 'application_number': 19766, 'submission_type': 'SUPPL ', 'submission_number': 93} |
11,703 |
NDA 19777/S-056
Page 3
ZESTRIL®
(lisinopril)
USE IN PREGNANCY
When used in pregnancy, during the second and third trimesters, ACE inhibitors can cause
injury and even death to the developing fetus. When pregnancy is detected, Zestril should be
discontinue... | custom-source | 2025-02-12T13:45:55.315345 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019777s056lbl.pdf', 'application_number': 19777, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,704 |
ZESTRIL®
(lisinopril)
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed
warning.
When pregnancy is detected, discontinue ZESTRIL as
soon as possible.
Drugs that act directly on the renin-angiotensin system
can cause injury and death to the deve... | custom-source | 2025-02-12T13:45:55.401946 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s059lbl.pdf', 'application_number': 19777, 'submission_type': 'SUPPL ', 'submission_number': 59} |
11,707 |
ZESTRIL®
(lisinopril) Tablets
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
· When pregnancy is detected, discontinue ZESTRIL as soon as possible.
· Drugs that act directly on the renin-angiotensin system can cause injury and death to the
... | custom-source | 2025-02-12T13:45:55.734224 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019777s063lbl.pdf', 'application_number': 19777, 'submission_type': 'SUPPL ', 'submission_number': 63} |
11,705 |
ZESTRIL®
(lisinopril) Tablets
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue ZESTRIL as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to t... | custom-source | 2025-02-12T13:45:55.833932 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s060lbl.pdf', 'application_number': 19777, 'submission_type': 'SUPPL ', 'submission_number': 60} |
11,706 | ZESTRIL®
(lisinopril) Tablets
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue ZESTRIL as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to
the developing fetus. See Warn... | custom-source | 2025-02-12T13:45:55.916821 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s061lbl.pdf', 'application_number': 19777, 'submission_type': 'SUPPL ', 'submission_number': 61} |
11,708 |
... | custom-source | 2025-02-12T13:45:56.020633 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019777s064lbl.pdf', 'application_number': 19777, 'submission_type': 'SUPPL ', 'submission_number': 64} |
11,710 | company logo
XXXXXXX
TABLETS
PRINZIDE®
(LISINOPRIL-HYDROCHLOROTHIAZIDE)
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause
injury and even death to the developing fetus. When pregnancy is detected, PRINZIDE ... | custom-source | 2025-02-12T13:45:56.155960 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019778s045lbl.pdf', 'application_number': 19778, 'submission_type': 'SUPPL ', 'submission_number': 45} |
11,709 |
HIGH... | custom-source | 2025-02-12T13:45:56.235432 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019777s073lbl.pdf', 'application_number': 19777, 'submission_type': 'SUPPL ', 'submission_number': 73} |
11,711 |
company logo
USPI-T-0521A1212R010
TABLETS
PRINZIDE®
(LISINOPRIL-HYDROCHLOROTHIAZIDE)
WARNING: FETAL TOXICITY
•
When pregnancy is detected, discontinue PRINZIDE as soon as possible.
•
Drugs that act directly on the renin-angiotensin system can cause injury and death to the
develo... | custom-source | 2025-02-12T13:45:56.316098 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019778s049lbl.pdf', 'application_number': 19778, 'submission_type': 'SUPPL ', 'submission_number': 49} |
11,712 |
NDA 19-779/S-014
Page 3
IOPIDINE
(apraclonidine hydrochloride ophthalmic solution)
1% As Base
Sterile
DESCRIPTION:
IOPIDINE Ophthalmic Solution contains apraclonidine hydrochloride, an alpha adrenergic
agonist, in a sterile isotonic solution for topical application to the eye. Apraclonidi... | custom-source | 2025-02-12T13:45:56.404004 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19779S14lbl.pdf', 'application_number': 19779, 'submission_type': 'SUPPL ', 'submission_number': 14} |
11,713 | NDA 19-779/S-018
NDA 19-779/S-019
Page 3
Package Insert Labeling
IOPIDINE
(apraclonidine hydrochloride ophthalmic solution) 1% as base
Sterile
DESCRIPTION:
IOPIDINE Ophthalmic Solution contains apraclonidine hydrochloride, an alpha adrenergic agonist, in
a sterile isotonic solution for topical applicatio... | custom-source | 2025-02-12T13:45:56.434295 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19779s018,019lbl.pdf', 'application_number': 19779, 'submission_type': 'SUPPL ', 'submission_number': 19} |
11,715 |
1
PROMETRIUM®
(progesterone, USP)
Capsules 100 mg
Capsules 200 mg
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA
FOR ESTROGEN PLUS PROGESTIN THERAPY
Cardiovascular Disorders and Probable Dementia
Estrogens plus progestin therapy should n... | custom-source | 2025-02-12T13:45:56.686645 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019781s017,020843s011lbl.pdf', 'application_number': 19781, 'submission_type': 'SUPPL ', 'submission_number': 17} |
11,717 | NDA 19-787/S-042
Page 2
Amlodipine Besylate
Tablets
DESCRIPTION
Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.
Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-
4-(2-chlorophenyl)-1,4-dihydro-6-methy... | custom-source | 2025-02-12T13:45:56.742837 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019787s042lbl.pdf', 'application_number': 19787, 'submission_type': 'SUPPL ', 'submission_number': 42} |
11,714 | 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 | 2025-02-12T13:45:56.774051 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19781lbl.pdf', 'application_number': 19781, 'submission_type': 'ORIG ', 'submission_number': 1} |
11,716 | 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 | 2025-02-12T13:45:56.804273 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019785s018lbl.pdf', 'application_number': 19785, 'submission_type': 'SUPPL ', 'submission_number': 18} |
11,718 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:45:57.051916 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019787s052lbl.pdf', 'application_number': 19787, 'submission_type': 'SUPPL ', 'submission_number': 52} |
11,720 |
... | custom-source | 2025-02-12T13:45:57.152824 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019787s054lbl.pdf', 'application_number': 19787, 'submission_type': 'SUPPL ', 'submission_number': 54} |
11,721 |
... | custom-source | 2025-02-12T13:45:57.256304 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019787s059lbl.pdf', 'application_number': 19787, 'submission_type': 'SUPPL ', 'submission_number': 59} |
11,719 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
NORVASC safely and effectively. See full prescribing information for
NORVASC.
NORVASC® (amlodipine besylate) Tablets for oral administration
Initial U.S. Approval: 1987
---------------------------INDICAT... | custom-source | 2025-02-12T13:45:57.321031 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019787s053lbl.pdf', 'application_number': 19787, 'submission_type': 'SUPPL ', 'submission_number': 53} |
11,722 | 1
F-XXXXXXXX
ELOCON
brand of mometasone furoate
Lotion 0.1%
For Dermatologic Use Only
Not for Ophthalmic Use
DESCRIPTION ELOCON (mometasone furoate topical solution) Lotion, 0.1%, contains
mometasone furoate, USP for dermatologic use. Mometasone furoate is a synthetic
corticosteroid with anti-inflammatory activity.... | custom-source | 2025-02-12T13:45:57.428764 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19796s8s15lbl.pdf', 'application_number': 19796, 'submission_type': 'SUPPL ', 'submission_number': 15} |
11,724 |
... | custom-source | 2025-02-12T13:45:57.651561 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019797s022lbl.pdf', 'application_number': 19797, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,725 |
Intravenous Solutions
with Heparin Sodium Injection
Rx only
20,000 or 25,000 USP Units of Heparin Sodium in 5% Dextrose Injection
Flexible Plastic Container
DESCRIPTION
Intravenous solutions with heparin sodium (derived from porcine inte... | custom-source | 2025-02-12T13:45:57.690335 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019805s029lbl.pdf', 'application_number': 19805, 'submission_type': 'SUPPL ', 'submission_number': 29} |
11,723 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ELOCON Lotion safely and effectively. See full prescribing
information for ELOCON Lotion.
ELOCON
® (mometasone furoate) Lotion, 0.1% for topical use
Initial U.S. Approval: 1987
----------------------------I... | custom-source | 2025-02-12T13:45:57.762842 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019796s026lbl.pdf', 'application_number': 19796, 'submission_type': 'SUPPL ', 'submission_number': 26} |
11,726 |
structural formula
KerledexTM
(betaxolol hydrochloride and chlorthalidone)
DESCRIPTION
Kerledex (betaxolol hydrochloride and chlorthalidone) is a combination product indicated for the
treatment of hypertension. It combines the activities of betaxolol hydrochloride, a
1-selective
(cardios... | custom-source | 2025-02-12T13:45:57.828021 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019807s002lbl.pdf', 'application_number': 19807, 'submission_type': 'SUPPL ', 'submission_number': 2} |
11,728 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the informatio... | custom-source | 2025-02-12T13:45:58.047747 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056s001019810s087lbl.pdf', 'application_number': 19810, 'submission_type': 'SUPPL ', 'submission_number': 87} |
11,727 | NDA 19-810/S-085
Page 3
PRILOSEC®
(OMEPRAZOLE)
DELAYED-RELEASE CAPSULES
DESCRIPTION
The active ingredient in PRILOSEC (omeprazole) Delayed-Release Capsules is a substituted
benzimidazole,
5-methoxy-2-[[(4-methoxy-3,
5-dimethyl-2-pyridinyl)
methyl]
sulfinyl]-1H-
benzimidazole, a compound that inhibits... | custom-source | 2025-02-12T13:45:58.296896 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019810s085lbl.pdf', 'application_number': 19810, 'submission_type': 'SUPPL ', 'submission_number': 85} |
11,730 |
______________________________________________________________________________________________... | custom-source | 2025-02-12T13:45:58.593212 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s092,022056s008lbl.pdf', 'application_number': 19810, 'submission_type': 'SUPPL ', 'submission_number': 92} |
11,729 |
____________________________________________________________________________________... | custom-source | 2025-02-12T13:45:58.636035 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022056s007,019810s091lbl.pdf', 'application_number': 19810, 'submission_type': 'SUPPL ', 'submission_number': 91} |
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