id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
11,832 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ALTACE safely and effectively. S... | custom-source | 2025-02-12T13:46:16.420561 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019901s059lbl.pdf', 'application_number': 19901, 'submission_type': 'SUPPL ', 'submission_number': 59} |
11,834 | 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 o... | custom-source | 2025-02-12T13:46:16.626791 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019906s032lbl.pdf', 'application_number': 19906, 'submission_type': 'SUPPL ', 'submission_number': 32} |
11,835 |
Page 1 of 23
Anafranil®
Clomipramine Hydrochloride Capsules USP
(25 mg, 50 mg, and 75 mg)
Rx only
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... | custom-source | 2025-02-12T13:46:16.782736 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019906s34lbl.pdf', 'application_number': 19906, 'submission_type': 'SUPPL ', 'submission_number': 34} |
11,836 |
Anafranil™
(clomipramine hydrochloride) Capsules USP
(25 mg, 50 mg, and 75 mg)
Rx only
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-te... | custom-source | 2025-02-12T13:46:16.852308 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019906s037lbl.pdf', 'application_number': 19906, 'submission_type': 'SUPPL ', 'submission_number': 37} |
11,837 |
Anafranil™
(clomipramine hydrochloride) Capsules USP
(25 mg, 50 mg, and 75 mg)
Rx only
Suicidality and Antidepressant Drugs
Antidepressants increased the risk com... | custom-source | 2025-02-12T13:46:17.027595 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019906s038lbl.pdf', 'application_number': 19906, 'submission_type': 'SUPPL ', 'submission_number': 38} |
11,838 |
Anafranil™
(clomipramine hydrochloride) Capsules USP
(25 mg, 50 mg, and 75 mg)
Rx only
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and
behavior (suicidality) in children, adolescents, and young adults in shor... | custom-source | 2025-02-12T13:46:17.177437 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019906s039lbl.pdf', 'application_number': 19906, 'submission_type': 'SUPPL ', 'submission_number': 39} |
11,840 |
... | custom-source | 2025-02-12T13:46:17.313482 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019908s027lbl.pdf', 'application_number': 19908, 'submission_type': 'SUPPL ', 'submission_number': 27} |
11,839 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
AMBIEN safely and effectively. See full prescribing information for
AMBIEN
Ambien® (zolpidem tartrate) tablets for oral administration
Initial US Approval: 1992
----------------------------RECENT MAJOR CHANG... | custom-source | 2025-02-12T13:46:17.387646 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019908s022lbl.pdf', 'application_number': 19908, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,843 | NDA 18-828/SLR-029
NDA 19-909/SLR-019
NDA 20-089/SLR-018
Page 3
PRESCRIBING INFORMATION
ZOVIRAX®
(acyclovir)
Capsules
ZOVIRAX®
(acyclovir)
Tablets
ZOVIRAX®
(acyclovir)
Suspension
DESCRIPTION
ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against ... | custom-source | 2025-02-12T13:46:17.552115 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18828slr029,19909slr019,20089slr018_zovirax_lbl.pdf', 'application_number': 19909, 'submission_type': 'SUPPL ', 'submission_number': 19} |
11,842 | NDA 18-828/S-026, S-027
NDA 19-909/S-016, S-017
NDA 20-089/S-015, S-016
Page 3
PRODUCT INFORMATION
ZOVIRAX® (acyclovir) Capsules
ZOVIRAX® (acyclovir) Tablets
ZOVIRAX® (acyclovir) Suspension
DESCRIPTION: ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue
active against herpesviruses. ZOVIRAX Capsul... | custom-source | 2025-02-12T13:46:17.603792 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19909s16s17lbl.pdf', 'application_number': 19909, 'submission_type': 'SUPPL ', 'submission_number': 17} |
11,846 | 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 | 2025-02-12T13:46:17.829373 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s41,019910s29,020518s13lbl.pdf', 'application_number': 19910, 'submission_type': 'SUPPL ', 'submission_number': 29} |
11,845 | NDA 19-655/S-039
NDA 19-910/S-027
NDA 20-528/S-011
Page 3
PRESCRIBING INFORMATION
RETROVIR®
(zidovudine)
Tablets
RETROVIR®
(zidovudine)
Capsules
RETROVIR®
(zidovudine)
Syrup
WARNING
RETROVIR (ZIDOVUDINE) HAS BEEN ASSOCIATED WITH HEMATOLOGIC
TOXICITY INCLUDING NEUTROPENIA AND SEVERE ANEMI... | custom-source | 2025-02-12T13:46:18.508643 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19655slr039,19910slr027,20528slr011_retrovir_lbl.pdf', 'application_number': 19910, 'submission_type': 'SUPPL ', 'submission_number': 27} |
11,847 | 3
PRESCRIBING INFORMATION
RETROVIR®
(zidovudine)
Tablets
RETROVIR®
(zidovudine)
Capsules
RETROVIR®
(zidovudine)
Syrup
WARNING
RETROVIR (ZIDOVUDINE) HAS BEEN ASSOCIATED WITH HEMATOLOGIC
TOXICITY INCLUDING NEUTROPENIA AND SEVERE ANEMIA PARTICULARLY
IN PATIENTS WITH ADVANCED HUMAN IMMUNODEFICIENC... | custom-source | 2025-02-12T13:46:18.552195 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019910s032lbl.pdf', 'application_number': 19910, 'submission_type': 'SUPPL ', 'submission_number': 32} |
11,844 | RETROVIR® (zidovudine) Tablets, Capsules, and Syrup
1
PRODUCT INFORMATION
1
RETROVIR® (zidovudine) Tablets
2
RETROVIR® (zidovudine) Capsules
3
RETROVIR® (zidovudine) Syrup
4
5
WARNING: RETROVIR (ZIDOVUDINE) MAY BE ASSOCIATED WITH
6
HEMATOLOGIC TOXICITY INCLUDING GRANULOCYTOPENIA AND SEVERE
7
ANEMIA PARTICULARLY IN PATI... | custom-source | 2025-02-12T13:46:18.655365 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19910s24lbl.pdf', 'application_number': 19910, 'submission_type': 'SUPPL ', 'submission_number': 24} |
11,841 |
HIGHLIGHTS OF PRESCRIB... | custom-source | 2025-02-12T13:46:18.748089 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf', 'application_number': 19908, 'submission_type': 'SUPPL ', 'submission_number': 32} |
11,851 |
NIZORAL® (KETOCONAZOLE) 2% SHAMPOO
DESCRIPTION
NIZORAL® (ketoconazole) 2% Shampoo is a red-orange liquid for topical application,
containing the broad spectrum synthetic antifungal agent ketoconazole in a concentration of 2%
in an aqueous suspension. It also contains: coconut fatty acid diethanolami... | custom-source | 2025-02-12T13:46:19.062491 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019927s031lbl.pdf', 'application_number': 19927, 'submission_type': 'SUPPL ', 'submission_number': 31} |
11,850 |
EN-1179 Page 1 of 6
PRESERVATIVE-FREE
MORPHINE
SULFATE
Injection, USP Rx only
WARNING: MAY BE HABIT FORMING.
PCA Via... | custom-source | 2025-02-12T13:46:19.149703 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019916s004lbl.pdf', 'application_number': 19916, 'submission_type': 'SUPPL ', 'submission_number': 4} |
11,849 |
... | custom-source | 2025-02-12T13:46:19.417294 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019910s036lbl.pdf', 'application_number': 19910, 'submission_type': 'SUPPL ', 'submission_number': 36} |
11,852 |
NIZORAL® (KETOCONAZOLE) 2% SHAMPOO
DESCRIPTION
NIZORAL® (ketoconazole) 2% Shampoo is a red-orange liquid for topical
application, containing the broad spectrum synthetic antifungal agent ketoconazole
in a concentration of 2% in an aqueous suspension. It also contains: coconut fatty
acid diethanolamide, dis... | custom-source | 2025-02-12T13:46:19.530238 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019927s032lbl.pdf', 'application_number': 19927, 'submission_type': 'SUPPL ', 'submission_number': 32} |
11,848 |
... | custom-source | 2025-02-12T13:46:19.558583 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019910s035lbl.pdf', 'application_number': 19910, 'submission_type': 'SUPPL ', 'submission_number': 35} |
11,853 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
| custom-source | 2025-02-12T13:46:19.736882 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19931slr008_Aventis_lbl.pdf', 'application_number': 19931, 'submission_type': 'SUPPL ', 'submission_number': 8} |
11,854 |
S
tructural Formula
ADENOCARD® IV
(adenosine injection)
FOR RAPID BOLUS INTRAVENOUS USE
Description
Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6
amino-9-β-D-ribofuranosyl-9-H-purine and has the following structural formula:
Adenosine is a wh... | custom-source | 2025-02-12T13:46:19.772789 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019937s024lbl.pdf', 'application_number': 19937, 'submission_type': 'SUPPL ', 'submission_number': 24} |
11,857 | 1
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NDAs 19-938, 19-959, 19-991, & 20-986
NovoPen 3 Demi Final revision
Page 2
2
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www... | custom-source | 2025-02-12T13:46:19.870131 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s33lbl.pdf', 'application_number': 19938, 'submission_type': 'SUPPL ', 'submission_number': 33} |
11,858 | NDA 19-938/S-048
Page 1
Novolin® R
Regular,
Human Insulin Injection
(recombinant DNA origin) USP
100 units/mL
DESCRIPTION
Novolin® R Regular, Human Insulin Injection (rDNA origin) USP is a polypeptide hormone
structurally identical to natural human insulin and is produced by rDNA technolog... | custom-source | 2025-02-12T13:46:20.021917 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019938s048lbl.pdf', 'application_number': 19938, 'submission_type': 'SUPPL ', 'submission_number': 48} |
11,859 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Novolin
R safely and effectively. See full prescribing information for Novolin R.
Novolin® R (Regular, Human Insulin [rDNA origin] USP) solution for
subcutaneous or intravenous use
Initial U.S. Approval: 19... | custom-source | 2025-02-12T13:46:20.399363 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019938s071lbl.pdf', 'application_number': 19938, 'submission_type': 'SUPPL ', 'submission_number': 71} |
11,860 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:46:20.425616 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019938s072lbl.pdf', 'application_number': 19938, 'submission_type': 'SUPPL ', 'submission_number': 72} |
11,861 |
... | custom-source | 2025-02-12T13:46:20.739767 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019938s074lbl.pdf', 'application_number': 19938, 'submission_type': 'SUPPL ', 'submission_number': 74} |
12,081 | NDA 19-941/S-018
Page 3
DESCRIPTION
EMLA Cream (lidocaine 2.5% and prilocaine 2.5%) is an emulsion in which the oil phase is a eutectic
mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting
point below room temperature and therefore both local anesthetics exi... | custom-source | 2025-02-12T13:46:20.775400 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019941s018lbl.pdf', 'application_number': 19941, 'submission_type': 'SUPPL ', 'submission_number': 18} |
12,082 |
LUPRON DEPOT - leuprolide acetate injection, powder, lyophilized, for suspension
Abbott Laboratories
-
LUPRON DEPOT® 3.75 mg
(leuprolide acetate for depot suspension)
Rx only
DESCRIPTION
Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring
gonadotropin-releasing hormone (GnRH or L... | custom-source | 2025-02-12T13:46:20.912526 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019943s030,020011s037lbl.pdf', 'application_number': 19943, 'submission_type': 'SUPPL ', 'submission_number': 30} |
12,083 |
1
23-4526-00-1
PATIENT INFORMATION
DIFLUCAN (fluconazole tablets)
This leaflet contains important information about DIFLUCAN (dye-FLEW-kan). It is not
meant to take the place of your doctor's instructions. Read this information carefully before
you take DIFLUCAN. Ask your doctor or pharmacist if you do no... | custom-source | 2025-02-12T13:46:20.934370 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20090slr019_diflucan_lbl.pdf', 'application_number': 19949, 'submission_type': 'SUPPL ', 'submission_number': 37} |
12,084 |
DIFLUCAN®
(Fluconazole Tablets)
(Fluconazole Injection - for intravenous infusion only)
(Fluconazole for Oral Suspension)
DESCRIPTION
DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is
available as tablets for oral admin... | custom-source | 2025-02-12T13:46:21.755310 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,020090s031lbl.pdf', 'application_number': 19949, 'submission_type': 'SUPPL ', 'submission_number': 48} |
12,085 |
s
t
ruc
tur
al f
or
mu
la
DIFLUCAN®
(Fluconazole Tablets)
(Fluconazole Injection - for intravenous infusion only)
(Fluconazole for Oral Suspension)
DESCRIPTION
DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is
available as ta... | custom-source | 2025-02-12T13:46:21.815076 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s052,019950s057,020090s036lbl.pdf', 'application_number': 19949, 'submission_type': 'SUPPL ', 'submission_number': 52} |
12,086 | str
uct
ural
f
or
mu
la
DIFLUCAN®
(Fluconazole Tablets)
(Fluconazole Injection - for intravenous infusion only)
(Fluconazole for Oral Suspension)
DESCRIPTION
DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is
available as tablets for oral administration, as a pow... | custom-source | 2025-02-12T13:46:21.917128 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019949s057,019950s061,020090s040lbl.pdf', 'application_number': 19949, 'submission_type': 'SUPPL ', 'submission_number': 57} |
12,087 |
s
t
ruc
tur
al f
or
mu
la
DIFLUCAN®
(Fluconazole Tablets)
(Fluconazole Injection - for intravenous infusion only)
(Fluconazole for Oral Suspension)
DESCRIPTION
DIFLUCAN® ... | custom-source | 2025-02-12T13:46:22.057083 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s058,019950s062,020090s042lbl.pdf', 'application_number': 19949, 'submission_type': 'SUPPL ', 'submission_number': 58} |
12,089 |
1
23-4526-00-1
PATIENT INFORMATION
DIFLUCAN (fluconazole tablets)
This leaflet contains important information about DIFLUCAN (dye-FLEW-kan). It is not
meant to take the place of your doctor's instructions. Read this information carefully before
you take DIFLUCAN. Ask your doctor or pharmacist if you do no... | custom-source | 2025-02-12T13:46:22.061796 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20090slr019_diflucan_lbl.pdf', 'application_number': 19950, 'submission_type': 'SUPPL ', 'submission_number': 39} |
12,088 | DIFLUCAN®
(Fluconazole Tablets)
(Fluconazole Injection - for intravenous infusion only)
(Fluconazole for Oral Suspension)
DESCRIPTION
DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is
available as tablets for oral administration, as a powder for oral suspension and as a st... | custom-source | 2025-02-12T13:46:22.383075 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf', 'application_number': 19950, 'submission_type': 'SUPPL ', 'submission_number': 37} |
12,090 |
DIFLUCAN®
(Fluconazole Tablets)
(Fluconazole Injection - for intravenous infusion only)
(Fluconazole for Oral Suspension)
DESCRIPTION
DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is
available as tablets for oral admin... | custom-source | 2025-02-12T13:46:22.576711 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,020090s031lbl.pdf', 'application_number': 19950, 'submission_type': 'SUPPL ', 'submission_number': 53} |
12,091 |
DIFLUCAN®
(Fluconazole Tablets)
(Fluconazole Injection - for intravenous infusion only)
(Fluconazole for Oral Suspension)
DESCRIPTION
DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is
available as tablets for oral adminis... | custom-source | 2025-02-12T13:46:22.773656 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019950s056lbl.pdf', 'application_number': 19950, 'submission_type': 'SUPPL ', 'submission_number': 56} |
12,092 |
s
t
ruc
tur
al f
or
mu
la
DIFLUCAN®
(Fluconazole Tablets)
(Fluconazole Injection - for intravenous infusion only)
(Fluconazole for Oral Suspension)
DESCRIPTION
DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is
available as ta... | custom-source | 2025-02-12T13:46:22.811744 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s052,019950s057,020090s036lbl.pdf', 'application_number': 19950, 'submission_type': 'SUPPL ', 'submission_number': 57} |
12,094 | NDA 19-951 RETROVIR IV Infusion
Page 3
PRODUCT INFORMATION
RETROVIR®
(zidovudine)
IV Infusion
FOR INTRAVENOUS INFUSION ONLY
WARNING: RETROVIR (ZIDOVUDINE) HAS BEEN ASSOCIATED WITH
HEMATOLOGIC TOXICITY, INCLUDING NEUTROPENIA AND SEVERE ANEMIA,
PARTICULARLY IN PATIENTS WITH ADVANCED HIV DISEASE (SEE WARN... | custom-source | 2025-02-12T13:46:23.107769 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19951slr018_retrovir_lbl.pdf', 'application_number': 19951, 'submission_type': 'SUPPL ', 'submission_number': 18} |
12,095 |
... | custom-source | 2025-02-12T13:46:23.329548 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf', 'application_number': 19951, 'submission_type': 'SUPPL ', 'submission_number': 32} |
12,096 |
... | custom-source | 2025-02-12T13:46:23.336113 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019952s033lbl.pdf', 'application_number': 19952, 'submission_type': 'SUPPL ', 'submission_number': 33} |
12,093 | RETROVIR® (zidovudine) IV Infusion
1
PRODUCT INFORMATION
1
2
RETROVIR®
3
(zidovudine)
4
IV Infusion
5
FOR INTRAVENOUS INFUSION ONLY
6
7
WARNING: RETROVIR (ZIDOVUDINE) MAY BE ASSOCIATED WITH HEMATOLOGIC TOXICITY
8
INCLUDING NEUTROPENIA AND SEVERE ANEMIA PARTICULARLY IN PATIENTS WITH
9
ADVANCED HIV DISEASE (SEE WARNINGS)... | custom-source | 2025-02-12T13:46:23.422325 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19951s16lbl.pdf', 'application_number': 19951, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,101 | NDAs 19-938, 19-959, 19-991, & 20-986
NovoPen Junior Final revision
Page 1
1
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NDAs 19-938, 19-959, 19-991, & 20-986
NovoPen Junior Final revision
Page 2
2
This label may not be the latest ap... | custom-source | 2025-02-12T13:46:23.669322 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s32lbl.pdf', 'application_number': 19959, 'submission_type': 'SUPPL ', 'submission_number': 34} |
12,099 | NDA 19-957/S-007
NDA 19-957/S-009
Page 3
PRODUCT INFORMATION
CUTIVATE®
(fluticasone propionate ointment)
Ointment, 0.005%
For Dermatologic Use Only—
Not for Ophthalmic Use.
DESCRIPTION: CUTIVATE (fluticasone propionate ointment) Ointment, 0.005% contains
fluticasone propionate [(6α,11β,16α... | custom-source | 2025-02-12T13:46:23.711812 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf', 'application_number': 19957, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,097 |
... | custom-source | 2025-02-12T13:46:24.182954 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019953s032lbl.pdf', 'application_number': 19953, 'submission_type': 'SUPPL ', 'submission_number': 32} |
12,100 | NDA 19-957/S-011
Page 1
PRODUCT INFORMATION
CUTIVATE®
(fluticasone propionate ointment)
Ointment, 0.005%
For Dermatologic Use Only—
Not for Ophthalmic Use.
DESCRIPTION: CUTIVATE (fluticasone propionate ointment) Ointment, 0.005% contains fluticasone propionate [(6α,11
β,16α,17α)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo... | custom-source | 2025-02-12T13:46:24.183271 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf', 'application_number': 19957, 'submission_type': 'SUPPL ', 'submission_number': 11} |
12,106 | custom-source | 2025-02-12T13:46:24.520166 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-962S013_Toprol_prntlbl.pdf', 'application_number': 19962, 'submission_type': 'SUPPL ', 'submission_number': 13} | |
12,109 |
______________________________________________________________________________
... | custom-source | 2025-02-12T13:46:24.535601 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019962s042lbl.pdf', 'application_number': 19962, 'submission_type': 'SUPPL ', 'submission_number': 42} |
12,108 |
______________________________________________________________________________
... | custom-source | 2025-02-12T13:46:24.604891 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019962s041lbl.pdf', 'application_number': 19962, 'submission_type': 'SUPPL ', 'submission_number': 41} |
12,107 | 1
METOPROLOL SUCCINATE
Extended-release Tablets
DESCRIPTION
Metoprolol succinate, is a beta1-selective (cardioselective)
adrenoceptor blocking agent, for oral administration, available
as extended-release tablets. Metoprolol succinate extended-
release tablet has been formulated to provide a controlled and
p... | custom-source | 2025-02-12T13:46:24.640146 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019962s036lbl.pdf', 'application_number': 19962, 'submission_type': 'SUPPL ', 'submission_number': 36} |
12,111 | TERAZOL 7(terconazole) Vaginal Cream 0.4%
TERAZOL 3(terconazole) Vaginal Cream 0.8%
TERAZOL® 3 (terconazole) Vaginal Suppositories 80 mg
DESCRIPTION
TERAZOL® 7(terconazole) Vaginal Cream 0.4% is a white to off-white, water washable
cream for intravaginal administration containing 0.4% of the antifungal agent
terconaz... | custom-source | 2025-02-12T13:46:24.757495 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19579slr026,19641slr022,19964slr021_terazol_lbl.pdf', 'application_number': 19964, 'submission_type': 'SUPPL ', 'submission_number': 21} |
12,110 | TERAZOL
7(terconazole) Vaginal Cream 0.4%
TERAZOL
3(terconazole) Vaginal Cream 0.8%
TERAZOL® 3 (terconazole) Vaginal Suppositories 80 mg
DESCRIPTION
TERAZOL® 7(terconazole) Vaginal Cream 0.4% is a white to off-white, water washable
cream for intravaginal administration containing 0.4% of the antifungal agent
terc... | custom-source | 2025-02-12T13:46:24.785383 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf', 'application_number': 19964, 'submission_type': 'SUPPL ', 'submission_number': 11} |
12,114 | Ultravate®
(halobetasol propionate ointment) Ointment, 0.05%
For Dermatological Use Only. Not for Ophthalmic Use.
DESCRIPTION
Ultravate® (halobetasol propionate ointment) Ointment, 0.05% contains halobetasol propionate, a synthetic corticosteroid for top-
ical dermatological use. The corticosteroids constitute a class ... | custom-source | 2025-02-12T13:46:24.987115 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19968s007lbl.pdf', 'application_number': 19968, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,113 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
| custom-source | 2025-02-12T13:46:25.034267 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019966s008lbl.pdf', 'application_number': 19966, 'submission_type': 'SUPPL ', 'submission_number': 8} |
12,115 |
Zebeta®
(Bisoprolol Fumarate) Tablets
November 2010
799-33-100004
Rx only
DESCRIPTION
Zebeta (bisoprolol fumarate) is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent.
The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethox... | custom-source | 2025-02-12T13:46:25.089063 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019982s016lbl.pdf', 'application_number': 19982, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,116 | 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 | 2025-02-12T13:46:25.230059 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19983s16lbl.pdf', 'application_number': 19983, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,119 | NDA 19-991/S-037 (document submission date 8/14/01)
FDA revision date 8/21/01
Page 1
Novo Nordisk
Insulin Information For The Patient Using
Novolin® 70/30 FlexPen
70% NPH, Human Insulin Isophane (recombinant DNA origin)
Suspension & and 30% Regular, Human Insulin (recombinant DNA origin)
Injection (recombinant DNA ... | custom-source | 2025-02-12T13:46:25.318469 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19991s37lbl.pdf', 'application_number': 19991, 'submission_type': 'SUPPL ', 'submission_number': 37} |
12,124 |
PRESCRIBING INFORMATION
1
ZOFRAN®
2
(ondansetron hydrochloride)
3
Injection
4
5
ZOFRAN®
6
(ondansetron hydrochloride)
7
Injection Premixed
8
DESCRIPTION
9
The active ingredient in ZOFRAN Injection and ZOFRAN Injection Premixed is ondansetron
10
hydrochloride (HCl), the racemic form of ondanse... | custom-source | 2025-02-12T13:46:25.433680 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20007s034,20403s013lbl.pdf', 'application_number': 20007, 'submission_type': 'SUPPL ', 'submission_number': 34} |
12,123 | NDA 19-992/S-020
Page 3
CILOXAN®
(ciprofloxacin HCL ophthalmic solution)
0.3% as Base
Sterile
DESCRIPTION:
CILOXAN® (ciprofloxacin HCL ophthalmic solution) is a synthetic, sterile, multiple dose,
antimicrobial for topical use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad
spe... | custom-source | 2025-02-12T13:46:25.441065 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019992s020lbl.pdf', 'application_number': 19992, 'submission_type': 'SUPPL ', 'submission_number': 20} |
12,125 | NDA 20-007/S-035
Page 3
PRESCRIBING INFORMATION
ZOFRAN®
(ondansetron hydrochloride)
Injection
ZOFRAN®
(ondansetron hydrochloride)
Injection Premixed
DESCRIPTION
The active ingredient in ZOFRAN Injection and ZOFRAN Injection Premixed is
ondansetron hydrochloride (HCl), the racemic form of ondansetro... | custom-source | 2025-02-12T13:46:25.641953 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20007s035lbl.pdf', 'application_number': 20007, 'submission_type': 'SUPPL ', 'submission_number': 35} |
12,126 |
DOCUMENT INFORMATION PAGE
This page is for FDA internal use only. Do NOT send this page with the letter.
Application #(s):
NDA 20-007/S-037
NDA 20-403/S-014
Document Type:
NDA Letters
Document Group:
NDA Supplement Approval Letters
Document Name:
Approval, effective on date of letter, based on enclo... | custom-source | 2025-02-12T13:46:25.793456 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020007s037,020403s014lbl.pdf', 'application_number': 20007, 'submission_type': 'SUPPL ', 'submission_number': 37} |
12,127 |
PRESCRIBING INFORMATION
ZOFRAN®
(ondansetron hydrochloride)
Injection
DESCRIPTION
The active ingredient in ZOFRAN Injection is ondansetron hydrochloride (HCl), the racemic
form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type.
Chemically it is (±) 1, 2, 3,... | custom-source | 2025-02-12T13:46:25.871880 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf', 'application_number': 20007, 'submission_type': 'SUPPL ', 'submission_number': 40} |
12,128 |
... | custom-source | 2025-02-12T13:46:26.058415 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s042,020403s020lbl.pdf', 'application_number': 20007, 'submission_type': 'SUPPL ', 'submission_number': 42} |
12,129 |
... | custom-source | 2025-02-12T13:46:26.101439 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020007s043lbl.pdf', 'application_number': 20007, 'submission_type': 'SUPPL ', 'submission_number': 43} |
12,131 | 3
LOTRISONE®
1
(clotrimazole and
2
betamethasone dipropionate)
3
CREAM and LOTION
4
5
FOR
TOPICAL
USE
ONLY,
NOT
FOR
OPHTHALMIC,
ORAL,
OR
6
INTRAVAGINAL USE, NOT RECOMMENDED FOR PATIENTS UNDER THE
7
AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER DERMATITIS
8
9
DESCRIPTION LOTRISONE Cream and Lotion contain comb... | custom-source | 2025-02-12T13:46:26.200391 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20010slr003_Lotrisone_lbl.pdf', 'application_number': 20010, 'submission_type': 'SUPPL ', 'submission_number': 3} |
12,130 |
... | custom-source | 2025-02-12T13:46:26.288620 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020007s046lbl.pdf', 'application_number': 20007, 'submission_type': 'SUPPL ', 'submission_number': 46} |
12,132 | Page 1
LOTRISONE® Cream, USP
1
LOTRISONE® Lotion
2
(clotrimazole, USP and betamethasone dipropionate, USP)
3
FOR TOPICAL USE ONLY, NOT
FOR
OPHTHALMIC,
ORAL,
OR
4
INTRAVAGINAL USE, NOT RECOMMENDED FOR PATIENTS UNDER THE
5
AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER DERMATITIS
6
DESCRIPTION LOTRISONE Cream and Lo... | custom-source | 2025-02-12T13:46:26.521057 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20010slr005_lotrisone_lbl.pdf', 'application_number': 20010, 'submission_type': 'SUPPL ', 'submission_number': 5} |
12,133 |
LOTRISONE® Cream
LOTRISONE® Lotion
(clotrimazole and betamethasone dipropionate)
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE. NOT RECOMMENDED FOR PATIENTS UNDER THE
AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER DERMATITIS.
DESCRIPTION
LOTRISONE® Cream and Lotion co... | custom-source | 2025-02-12T13:46:26.596263 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020010s015lbl.pdf', 'application_number': 20010, 'submission_type': 'SUPPL ', 'submission_number': 15} |
12,134 | Lupron 3.75 mg Package Insert
03-5043-R12 Vs Revised Add-back (9-21-01)
1
This is combined labeling. Examples of different fonts and colors appear below.
• General information
• Information on endometriosis
• Information on uterine fibroids
LUPRON DEPOT®... | custom-source | 2025-02-12T13:46:26.701169 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20011s21lbl.pdf', 'application_number': 20011, 'submission_type': 'SUPPL ', 'submission_number': 21} |
12,135 |
Lupron Depot (leuprolide acetate for depot suspension) Injection, Powder, Lyophilized, For
Suspension
[Abbott Laboratories]
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 tha... | custom-source | 2025-02-12T13:46:26.832926 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019943s029,020011s036lbl.pdf', 'application_number': 20011, 'submission_type': 'SUPPL ', 'submission_number': 36} |
12,136 |
LUPRON DEPOT® 3.75 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-proly... | custom-source | 2025-02-12T13:46:26.927154 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019943s032,020011s039lbl.pdf', 'application_number': 20011, 'submission_type': 'SUPPL ', 'submission_number': 39} |
12,137 |
LUPRON DEPOT® 3.75 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-p... | custom-source | 2025-02-12T13:46:27.005346 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020011s040lbl.pdf', 'application_number': 20011, 'submission_type': 'SUPPL ', 'submission_number': 40} |
12,138 |
LUPRON DEPOT® 3.75 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 th... | custom-source | 2025-02-12T13:46:27.175235 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020011s041lbl.pdf', 'application_number': 20011, 'submission_type': 'SUPPL ', 'submission_number': 41} |
12,139 | UNIMED
Maxaquin®
(lomefloxacin hydrochloride)
Film-coated Tablets
DESCRIPTION
Maxaquin (lomefloxacin HCl) is a synthetic broad-spectrum antimicrobial agent for oral administration.
Lomefloxacin HCl, a difluoroquinolone, is the monohydrochloride salt of (±)-1-ethyl-6,8-difluoro-1,4-
dihydro-7-(3-methyl-1-piperazinyl)-4-... | custom-source | 2025-02-12T13:46:27.330809 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20013s8lbl.pdf', 'application_number': 20013, 'submission_type': 'SUPPL ', 'submission_number': 8} |
12,140 | Maxaquin®
lomefloxacin hydrochloride tablets
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
Maxaquin and other antibacterial drugs, Maxaquin should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Maxaquin (lo... | custom-source | 2025-02-12T13:46:27.476260 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20013slr014_mazaquin_lbl.pdf', 'application_number': 20013, 'submission_type': 'SUPPL ', 'submission_number': 14} |
12,142 | 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 | 2025-02-12T13:46:27.507707 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20031s045,20936s020lbl.pdf', 'application_number': 20031, 'submission_type': 'SUPPL ', 'submission_number': 45} |
12,143 | 1
PRESCRIBING INFORMATION
1
PAXIL®
2
(paroxetine hydrochloride)
3
Tablets and Oral Suspension
4
5
Suicidality and Antidepressant Drugs
6
Antidepressants increased the risk compared to placebo of suicidal thinking and
7
behavior (suicidality) in children, adolescents, and young adults in short-term ... | custom-source | 2025-02-12T13:46:27.719477 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020031s053,020710s017lbl.pdf', 'application_number': 20031, 'submission_type': 'SUPPL ', 'submission_number': 53} |
12,144 |
1
PRESCRIBING INFORMATION
2
PAXIL®
3
(paroxetine hydrochloride)
4
Tablets and Oral Suspension
5
6
Suicidality and Antidepressant Drugs
7
Antidepressants increased the risk compared to placebo of suicidal thinking and
8
behavior (suicidality) in children, adolescents, and young adult... | custom-source | 2025-02-12T13:46:27.966472 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s05920710s023lbl.pdf', 'application_number': 20031, 'submission_type': 'SUPPL ', 'submission_number': 59} |
12,141 | 1
NDA 20-031/S-026
PX:Lx
PRESCRIBING INFORMATION
PAXIL®
brand of
paroxetine hydrochloride tablets and oral suspension
DESCRIPTION
Paxil (paroxetine hydrochloride) is an orally administered antidepressant with a chemical structure
unrelated to other selective serotonin reuptake inhibitors or to tricyclic, tetracyclic or... | custom-source | 2025-02-12T13:46:28.107144 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20031S26lbl.pdf', 'application_number': 20031, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,145 |
PRESCRIBING INFORMATION
PAXIL®
(paroxetine hydrochloride)
Tablets and Oral Suspension
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
maj... | custom-source | 2025-02-12T13:46:29.455414 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020031s060,020936s037,020710s024lbl.pdf', 'application_number': 20031, 'submission_type': 'SUPPL ', 'submission_number': 60} |
12,146 |
structural formula
1
PRESCRIBING INFORMATION
2
PAXIL®
3
(paroxetine hydrochloride)
4
Tablets and Oral Suspension
5
6
Suicidality and Antidepressant Drugs
7
Antidepressants increased the risk compared to placebo of suicidal thinking and
8
behavior (suicidality) in children, adolescents, ... | custom-source | 2025-02-12T13:46:29.794078 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf', 'application_number': 20031, 'submission_type': 'SUPPL ', 'submission_number': 62} |
12,147 |
structural formula
1
PRESCRIBING INFORMATION
2
PAXIL®
3
(paroxetine hydrochloride)
4
Tablets and Oral Suspension
5
6
Suicidality and Antidepressant Drugs
7
Antidepressants increased the risk compared to placebo of suicidal thinking and
8
behavior (suicidality) in children, adolescents, ... | custom-source | 2025-02-12T13:46:30.135687 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf', 'application_number': 20031, 'submission_type': 'SUPPL ', 'submission_number': 65} |
12,148 |
PRESCRIBING INFORMATION
PAXIL®
(paroxetine hydrochloride)
Tablets and Oral Suspension
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinkin... | custom-source | 2025-02-12T13:46:30.166337 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020031s071,020710s035lbl.pdf', 'application_number': 20031, 'submission_type': 'SUPPL ', 'submission_number': 71} |
12,150 |
company logo
Lotensin HCT®
benazepril hydrochloride and hydrochlorothiazide USP
Combination Tablets
5 mg/6.25 mg
10 mg/12.5 mg
20 mg/12.5 mg
20 mg/25 mg
Rx only
Prescribing Information
USE IN PREGNANCY
When used in pregnancy, ACE inhibitors can cause injury and even death to the
developing fetus... | custom-source | 2025-02-12T13:46:30.319667 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020033s041lbl.pdf', 'application_number': 20033, 'submission_type': 'SUPPL ', 'submission_number': 41} |
12,149 |
company logo
Lotensin HCT®
benazepril hydrochloride and hydrochlorothiazide USP
Combination Tablets
5 mg/6.25 mg
10 mg/12.5 mg
20 mg/12.5 mg
20 mg/25 mg
Rx only
Prescribing Information
USE IN PREGNANCY
When used in pregnancy, ACE inhibitors can cause injury and even death to the
developing fetus... | custom-source | 2025-02-12T13:46:30.389876 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020033s040lbl.pdf', 'application_number': 20033, 'submission_type': 'SUPPL ', 'submission_number': 40} |
12,151 |
company logo
Lotensin HCT®
benazepril hydrochloride and hydrochlorothiazide USP
Combination Tablets
5 mg/6.25 mg
10 mg/12.5 mg
20 mg/12.5 mg
20 mg/25 mg
Rx only
Prescribing Information
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue Lotensin HCT as soon as possible.
Drugs that ... | custom-source | 2025-02-12T13:46:31.162089 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s045lbl.pdf', 'application_number': 20033, 'submission_type': 'SUPPL ', 'submission_number': 45} |
12,154 | Aredia®
pamidronate disodium for injection
For Intravenous Infusion
Rx only
Prescribing Information
DESCRIPTION
Aredia, pamidronate disodium (APD), is a bone-resorption inhibitor available in 30-mg or 90-mg vials for
intravenous administration. Each 30-mg, and 90-mg vial contains, respectively, 30 mg and 90 mg of ste... | custom-source | 2025-02-12T13:46:31.217655 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020036s031lbl.pdf', 'application_number': 20036, 'submission_type': 'SUPPL ', 'submission_number': 31} |
12,152 | T2001-xx
xxxxxxxx
Aredia
pamidronate disodium for injection
For Intravenous Infusion
Rx only
Prescribing Information
DESCRIPTION
Aredia, pamidronate disodium (APD), is a bone-resorption inhibitor available in 30-mg or 90-mg vials for
intravenous administration. Each 30-mg, and 90-mg vial contains, respectively, ... | custom-source | 2025-02-12T13:46:31.365430 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20036s24lbl.pdf', 'application_number': 20036, 'submission_type': 'SUPPL ', 'submission_number': 24} |
12,153 | Aredia®
pamidronate disodium for injection
For Intravenous Infusion
Rx only
Prescribing Information
DESCRIPTION
Aredia, pamidronate disodium (APD), is a bone-resorption inhibitor available in 30-mg or
90-mg vials for intravenous administration. Each 30-mg, and 90-mg vial contains, respectively,
30 mg and 90 mg of st... | custom-source | 2025-02-12T13:46:31.821880 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20036s030lbl.pdf', 'application_number': 20036, 'submission_type': 'SUPPL ', 'submission_number': 30} |
12,155 |
T2005-27
Aredia
pamidronate disodium for injection
For Intravenous Infusion
Rx only
Prescribing Information
DESCRIPTION
Aredia, pamidronate disodium (APD), is a bone-resorption inhibitor available in 30-mg or
90-mg vials for intravenous administration. Each 30-mg, and 90-mg vial contains,
respectively, 30 m... | custom-source | 2025-02-12T13:46:32.092390 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020036s032lbl.pdf', 'application_number': 20036, 'submission_type': 'SUPPL ', 'submission_number': 32} |
12,156 |
T2007-98
Aredia®
pamidronate disodium for injection
For Intravenous Infusion
Rx only
Prescribing Information
DESCRIPTION
Aredia, pamidronate disodium (APD), is a bone-resorption inhibitor available in 30-mg or
90-mg vials for intravenous administration. Each 30-mg and 90-mg vial contains,
respectively, 30 m... | custom-source | 2025-02-12T13:46:32.182807 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020036s034lbl.pdf', 'application_number': 20036, 'submission_type': 'SUPPL ', 'submission_number': 34} |
12,159 | NDA 20-037/S-014
Page 3
VOLTAREN OPHTHALMIC®
(diclofenac sodium ophthalmic solution) 0.1%
Sterile Ophthalmic Solution
Prescribing Information
DESCRIPTION
Voltaren Ophthalmic (diclofenac sodium ophthalmic solution) 0.1% solution is a sterile, topical,
nonsteroidal, anti-inflammatory product for ophthalmi... | custom-source | 2025-02-12T13:46:32.669657 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020037s014lbl.pdf', 'application_number': 20037, 'submission_type': 'SUPPL ', 'submission_number': 14} |
12,157 |
----------
... | custom-source | 2025-02-12T13:46:32.709376 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020036s035lbl.pdf', 'application_number': 20036, 'submission_type': 'SUPPL ', 'submission_number': 35} |
12,158 |
company logo
Aredia
pamidronate disodium for injection
For Intravenous Infusion
Rx only
Prescribing Information
DESCRIPTION
Aredia, pamidronate disodium (APD), is a bisphosphonate available in 30-mg or 90-mg vials for
intravenous administration. Each 30-mg and 90-mg vial contains, respectively,... | custom-source | 2025-02-12T13:46:32.933385 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020036s041lbl.pdf', 'application_number': 20036, 'submission_type': 'SUPPL ', 'submission_number': 41} |
12,160 | NDA 20-038/S-031
Page 3
Fludara®
(fludarabine phosphate)
FOR INJECTION
FOR INTRAVENOUS USE ONLY
Rx Only
WARNING: FLUDARA FOR INJECTION should be administered under the supervision of a qualified
physician experienced in the use of antineoplastic therapy. FLUDARA FOR INJECTION can severely
suppress bone ... | custom-source | 2025-02-12T13:46:32.983509 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020038s031lbl.pdf', 'application_number': 20038, 'submission_type': 'SUPPL ', 'submission_number': 31} |
12,161 |
Dextrose Injection, USP
in AVIVA Plastic Container
DESCRIPTION
Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid replenishment and
caloric supply in single dose containers for intra... | custom-source | 2025-02-12T13:46:33.108215 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf', 'application_number': 20047, 'submission_type': 'SUPPL ', 'submission_number': 20} |
12,162 | custom-source | 2025-02-12T13:46:33.119174 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20049-S006_Pentasa_prntlbl.pdf', 'application_number': 20049, 'submission_type': 'SUPPL ', 'submission_number': 6} | |
12,164 |
ADENOSCAN®
(adenosine injection)
FOR INTRAVENOUS INFUSION ONLY
DESCRIPTION
Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6
amino-9-beta-D-ribofuranosyl-9-H-purine and has the following structural formula: structural formula
C10H13... | custom-source | 2025-02-12T13:46:33.289724 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s016lbl.pdf', 'application_number': 20059, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,165 |
N20062/S-040
Page 2
CARDIZEM® CD
(diltiazem HCl)
Capsules
Rx only
DESCRIPTION
Cardizem (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel
blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin... | custom-source | 2025-02-12T13:46:33.399252 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020062s040lbl.pdf', 'application_number': 20062, 'submission_type': 'SUPPL ', 'submission_number': 40} |
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