id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
12,373 | NDA 19510/S-028
NDA 20249/S-011
Page 3
PEPCID®
(FAMOTIDINE) INJECTION PREMIXED
PEPCID®
(FAMOTIDINE) INJECTION
DESCRIPTION
The active ingredient in PEPCID* (famotidine) Injection Premixed and PEPCID (famotidine) Injection is a
histamine
H2-receptor
antagonist.
Famotidine
is
N'-(aminosulfonyl)-3-[[[2-[(... | custom-source | 2025-02-12T13:47:14.002468 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19510s28lbl20249s11lbl.pdf', 'application_number': 20249, 'submission_type': 'SUPPL ', 'submission_number': 11} |
12,372 |
... | custom-source | 2025-02-12T13:47:14.132259 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s053lbl.pdf', 'application_number': 20246, 'submission_type': 'SUPPL ', 'submission_number': 53} |
12,374 | 1
HL:L4
PRESCRIBING INFORMATION
HALFAN
brand of
halofantrine hydrochloride
Tablets
WARNING: HALFAN HAS BEEN SHOWN TO PROLONG QTc INTERVAL AT THE
RECOMMENDED THERAPEUTIC DOSE. THERE HAVE BEEN RARE REPORTS
OF SERIOUS VENTRICULAR DYSRHYTHMIAS SOMETIMES ASSOCIATED WITH
DEATH, WHICH MAY BE SUDDEN. HALFAN IS THEREFORE N... | custom-source | 2025-02-12T13:47:14.178508 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20250s7s8lbl.pdf', 'application_number': 20250, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,375 |
PRESCRIBING INFORMATION
ZANTAC® 150
(ranitidine hydrochloride)
Tablets, USP
ZANTAC® 300
(ranitidine hydrochloride)
Tablets, USP
ZANTAC® 25
(ranitidine hydrochloride effervescent)
EFFERdose® Tablets
ZANTAC®
(ranitidine hydrochloride)
Syrup, USP
DESCRIPTION... | custom-source | 2025-02-12T13:47:14.255641 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf', 'application_number': 20251, 'submission_type': 'SUPPL ', 'submission_number': 19} |
12,371 |
_______________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:47:14.544089 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020246s035lbl.pdf', 'application_number': 20246, 'submission_type': 'SUPPL ', 'submission_number': 35} |
12,378 | NDA 20-258/S-019
Page 3
IOPIDINE® 0.5%
(apraclonidine ophthalmic solution)
0.5% As Base
DESCRIPTION: IOPIDINE® 0.5% Ophthalmic Solution contains apraclonidine hydrochloride, an
alpha adrenergic agonist, in a sterile isotonic solution for topical application to the eye. Apraclonidine
hydrochloride is a white... | custom-source | 2025-02-12T13:47:14.668802 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20258slr019_iopidine_lbl.pdf', 'application_number': 20258, 'submission_type': 'SUPPL ', 'submission_number': 19} |
12,376 |
company logo
Voltaren®-XR
(diclofenac sodium extended-release) tablets, USP
Tablets of 100 mg
Rx only
Prescribing Information
Cardiovascular Risk
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events,
myocardial infarction, and stroke, whic... | custom-source | 2025-02-12T13:47:14.677466 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020254s019s020lbl.pdf', 'application_number': 20254, 'submission_type': 'SUPPL ', 'submission_number': 20} |
12,377 |
structural formula
s
tructu
ral
fo
rm
ula
*BAR CODE POSITION ONLY
07-19-69-716
07-19-71-235
Baxter
DOBUTamine Hydrochloride in 5% Dextrose Injection
in Plastic Container
VIAFLEX Plus... | custom-source | 2025-02-12T13:47:14.717331 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020255s016lbl.pdf', 'application_number': 20255, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,380 | 89011105
89011105
89011105
Lescol
®
(fluvastatin sodium)
Capsules
Lescol
® XL
(fluvastatin sodium)
Extended-Release Tablets
Rx only
Prescribing Information
DESCRIPTION
Lescol® (fluvastatin sodium), is a water-soluble cholesterol lowering agent which acts through the inhi-
bition of 3-hydroxy-3-methylglutaryl-coenzyme A... | custom-source | 2025-02-12T13:47:15.108163 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20261s32,21192s4lbl.pdf', 'application_number': 20261, 'submission_type': 'SUPPL ', 'submission_number': 32} |
12,381 | PATIENT INFORMATION
LESCOL® [ lĕs-cŏl]
(fluvastatin sodium)
Capsules
and
LESCOL® [ lĕs-cŏl] XL
(fluvastatin sodium)
Extended-release tablets
Read the Patient Information that comes with
LESCOL or LESCOL XL before you start taking it,
and each time you get a refill. There may be new
information. Th... | custom-source | 2025-02-12T13:47:15.127293 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20261s034,21192s008lbl.pdf', 'application_number': 20261, 'submission_type': 'SUPPL ', 'submission_number': 34} |
12,379 | custom-source | 2025-02-12T13:47:15.165863 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol_Prntlbl.pdf', 'application_number': 20261, 'submission_type': 'SUPPL ', 'submission_number': 28} | |
12,382 |
Lescol
®
(fluvastatin sodium)
Capsules
Lescol
® XL
(fluvastatin sodium)
Extended-Release Tablets
Rx only
Prescribing Information
DESCRIPTION
Lescol® (fluvastatin sodium), is a water-soluble cholesterol lowering agent which acts through
the inhibition of 3-hydroxy-3-methylglutaryl-coenz... | custom-source | 2025-02-12T13:47:15.240983 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf', 'application_number': 20261, 'submission_type': 'SUPPL ', 'submission_number': 36} |
12,386 | 1
Mead Johnson
ONCOLOGY PRODUCTS
CAUTION: FEDERAL LAW PROHIBITS
DISPENSING WITHOUT PRESCRIPTION
TAXOL7
(paclitaxel)
INJECTION
WARNING
TAXOL7 (paclitaxel) should be administered under the supervision of a physician experienced in the use of cancer
chemotherapeutic agents. Appropriate management of complications is poss... | custom-source | 2025-02-12T13:47:15.679505 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262s24lbl.pdf', 'application_number': 20262, 'submission_type': 'SUPPL ', 'submission_number': 24} |
12,384 |
Lescol
®
(fluvastatin sodium)
Capsules
Lescol
® XL
(fluvastatin sodium)
Extended-Release Tablets
Rx only
Prescribing Information
DESCRIPTION
Lescol® (fluvastatin sodium), is a water-soluble cholesterol lowering agent which acts through
the inhibition of 3-hydroxy-3... | custom-source | 2025-02-12T13:47:15.700246 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020261s039,021192s013lbl.pdf', 'application_number': 20261, 'submission_type': 'SUPPL ', 'submission_number': 39} |
12,385 |
... | custom-source | 2025-02-12T13:47:15.847453 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261s046lbl.pdf', 'application_number': 20261, 'submission_type': 'SUPPL ', 'submission_number': 46} |
12,387 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:47:15.872968 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf', 'application_number': 20262, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,388 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:47:15.983624 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf', 'application_number': 20262, 'submission_type': 'SUPPL ', 'submission_number': 28} |
12,391 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Percent of Patients
(n 812)
• Bone Marrow
—Neutropenia <2,000/mm3
90
<500/mm3
52
—Leukopenia <4,000/mm3
90
<1,000/mm3
17
—Thrombocytopenia <100,000/mm3
20
<50,000/mm3
... | custom-source | 2025-02-12T13:47:16.246257 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020262s051lbl.pdf', 'application_number': 20262, 'submission_type': 'SUPPL ', 'submission_number': 51} |
12,392 | NDA 20-263/S-024
Page 3
(No. 3612)
TAPDN126-V2, Rev. March 2, 2004
1993-Year TAP Pharmaceutical Products Inc.
For Pediatric Use
LUPRON®
(leuprolide acetate) Injection
DESCRIPTION
Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing
hormone (GnRH or LH-RH... | custom-source | 2025-02-12T13:47:16.318089 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20263slr024_lupron_lbl.pdf', 'application_number': 20263, 'submission_type': 'SUPPL ', 'submission_number': 24} |
12,393 | 035411
7
8
9
LUPRON DEPOT-PED
®
(leuprolide acetate for depot suspension)
7.5 mg, 11.25 mg and 15 mg
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 n... | custom-source | 2025-02-12T13:47:16.499184 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020263s026lbl.pdf', 'application_number': 20263, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,390 |
NDA 020262/S-048
Page 4
TAXOL® (paclitaxel) INJECTION
(Patient Information Included)
WARNING
TAXOL® (paclitaxel) should be administered under the supervision of a physician experienced
in the... | custom-source | 2025-02-12T13:47:16.687768 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020262s048lbl.pdf', 'application_number': 20262, 'submission_type': 'SUPPL ', 'submission_number': 48} |
12,395 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:47:16.829086 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20588s05lbl.pdf', 'application_number': 20272, 'submission_type': 'SUPPL ', 'submission_number': 9} |
12,396 | 1
JANSSEN
PHARMACEUTICA
PRODUCTS, L.P.
RISPERDAL®
(RISPERIDONE)
TABLETS/ORAL SOLUTION
RISPERDAL® M-TAB™
(RISPERIDONE)
ORALLY DISINTEGRATING TABLETS
DESCRIPTION
RISPERDAL® (risperidone) is a psychotropic agent belonging to the chemical class of
benzisoxazole
derivatives.
The
chemical
designatio... | custom-source | 2025-02-12T13:47:17.043866 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf', 'application_number': 20272, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,398 | NDA 20-272 / S-036, 20-588 / S-024, 21-444 / S-008: Final Agreed-Upon Labeling
1
JANSSEN, L.P.
RISPERDAL®
(risperidone)
TABLETS/ORAL SOLUTION
RISPERDAL® M-TAB®
(risperidone)
ORALLY DISINTEGRATING TABLETS
Increased Mortality in Elderly Patients with Dementia –Related Psychosis
Elderly patients with dem... | custom-source | 2025-02-12T13:47:17.264613 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf', 'application_number': 20272, 'submission_type': 'SUPPL ', 'submission_number': 41} |
12,397 | NDA 20-272 / S-036, 20-588 / S-024, 21-444 / S-008: Final Agreed-Upon Labeling
1
JANSSEN, L.P.
RISPERDAL®
(risperidone)
TABLETS/ORAL SOLUTION
RISPERDAL® M-TAB®
(risperidone)
ORALLY DISINTEGRATING TABLETS
Increased Mortality in Elderly Patients with Dementia –Related Psychosis
Elderly patients with dem... | custom-source | 2025-02-12T13:47:17.338094 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf', 'application_number': 20272, 'submission_type': 'SUPPL ', 'submission_number': 36} |
12,394 |
For Pediatric Use
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 -L-prol... | custom-source | 2025-02-12T13:47:17.388048 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020263s033lbl.pdf', 'application_number': 20263, 'submission_type': 'SUPPL ', 'submission_number': 33} |
12,399 |
1
JANSSEN
PHARMACEUTICA
PRODUCTS, L.P.
RISPERDAL
(RISPERIDONE)
TABLETS/ORAL SOLUTION
RISPERDAL M-TAB
(RISPERIDONE)
ORALLY DISINTEGRATING TABLETS
Increased Mortality in Elderly Patients with Dementia –Related Psychosis
Elderly patients with dementia-related psychosis treated with atypical
antipsyc... | custom-source | 2025-02-12T13:47:17.703354 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf', 'application_number': 20272, 'submission_type': 'SUPPL ', 'submission_number': 42} |
12,401 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
RISPERDAL® safely and effectively. See full prescribing information for
RISPERDAL®.
RISPERDAL® (risperidone) tablets, RISPERDAL® (risperidone) oral
solution, RISPERDAL® M-TAB® (risperidone) orally d... | custom-source | 2025-02-12T13:47:17.978241 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf', 'application_number': 20272, 'submission_type': 'SUPPL ', 'submission_number': 47} |
12,400 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
RISPERDAL® safely and effectively. See full prescribing information for
RISPERDAL®.
RISPERDAL® (risperidone) tablets, RISPERDAL® (risperidone) oral
solution, RISPERDAL® M-TAB® (risperidone) orally d... | custom-source | 2025-02-12T13:47:18.115475 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf', 'application_number': 20272, 'submission_type': 'SUPPL ', 'submission_number': 46} |
12,402 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
RISPERDAL® safely and effectively. See full prescribing information for
RISPERDAL®.
RISPERDAL® (risperidone) tablets, RISPERDAL® (risperidone) oral
solution, RISPERDAL® M-TAB® (risperidone) orally disintegratin... | custom-source | 2025-02-12T13:47:18.166046 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf', 'application_number': 20272, 'submission_type': 'SUPPL ', 'submission_number': 55} |
12,404 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
RISPERDAL® safely and effectively. See full prescribing information for
RISPERDAL®.
RISPERDAL® (risperidone) tablets, RISPERDAL® (risperidone) oral
solution, RISPERDAL® M-TAB® (risperidone) orally disintegratin... | custom-source | 2025-02-12T13:47:18.601807 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf', 'application_number': 20272, 'submission_type': 'SUPPL ', 'submission_number': 58} |
12,403 |
HIGHLIGHTS OF... | custom-source | 2025-02-12T13:47:19.306374 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf', 'application_number': 20272, 'submission_type': 'SUPPL ', 'submission_number': 56} |
12,405 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the... | custom-source | 2025-02-12T13:47:20.981336 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s059,020588s047,021444s034lbl.pdf', 'application_number': 20272, 'submission_type': 'SUPPL ', 'submission_number': 59} |
12,408 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
RISPERDAL® safely and effectively. See full prescribing information for
RISPERDAL®.
RISPERDAL® (risperidone) tablets, for oral use
RISPERDAL® (risperidone) oral solution
RISPERDAL® M-TAB® (risperidone) or... | custom-source | 2025-02-12T13:47:21.338967 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020272s065,020588s053,021444s041lbl.pdf', 'application_number': 20272, 'submission_type': 'SUPPL ', 'submission_number': 65} |
12,407 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the... | custom-source | 2025-02-12T13:47:21.775534 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s064,020588s052,021444s040lbl.pdf', 'application_number': 20272, 'submission_type': 'SUPPL ', 'submission_number': 64} |
12,409 | NDA 20-611/S-007, NDA 20-554/S-007, NDA 20-273/S-009
Page 3
Dovonex®
(calcipotriene solution)
Rx only
Scalp Solution, 0.005%
FOR TOPICAL DERMATOLOGIC USE ONLY.
Not for Ophthalmic, Oral or Intravaginal Use.
DESCRIPTION
Dovonex
®
(calcipotriene solution) Scalp Solution, 0.005% is a colorless topical sol... | custom-source | 2025-02-12T13:47:21.949315 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,020273s009lbl.pdf', 'application_number': 20273, 'submission_type': 'SUPPL ', 'submission_number': 9} |
12,410 |
DOVONEX®
(calcipotriene) Cream, 0.005%
Rx only
FOR TOPICAL DERMATOLOGIC USE ONLY.
Not for Ophthalmic, Oral or Intravaginal Use.
DESCRIPTION
Dovonex® (calcipotriene) Cream, 0.005% contains... | custom-source | 2025-02-12T13:47:22.181657 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020273s013,020554s012lbl.pdf', 'application_number': 20273, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,411 |
chem
i
c
a
l
st
ru
ct
ur
e
DERMATOP® Emollient Cream
(prednicarbate emollient cream) 0.1%
FOR DERMATOLOGIC USE ONLY.
NOT FOR USE IN EYES.
DESCRIPTION
DERMATOP® Emollient Cream (prednicarbate emollient cream) 0.1% contains
prednicarbate, a synthetic corticosteroid for topical der... | custom-source | 2025-02-12T13:47:22.259391 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020279s009lbl.pdf', 'application_number': 20279, 'submission_type': 'SUPPL ', 'submission_number': 9} |
12,413 |
Instructions for Use
Important Note
Please read these instructions completely before using the
GENOTROPIN PEN 5. If there is anything you
do not understand or cannot do, call the toll-free
number listed at the end of these instructions.
If you have any questions about your dose or your treatment
with GENOTRO... | custom-source | 2025-02-12T13:47:22.824933 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s055lbl.pdf', 'application_number': 20280, 'submission_type': 'SUPPL ', 'submission_number': 55} |
12,419 |
ULTRAM®
(tramadol hydrochloride) Tablets
Full Prescribing Information
DESCRIPTION
ULTRAM® (tramadol hydrochloride) tablets is a centrally acting analgesic. The chemical
name
for
tramadol
hydrochloride
is
(±)cis-2-[(dimethylamino)methyl]-1-(3
methoxyphenyl) cyclohexanol hydrochlor... | custom-source | 2025-02-12T13:47:23.204027 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020281s032s033lbl.pdf', 'application_number': 20281, 'submission_type': 'SUPPL ', 'submission_number': 33} |
12,406 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the inf... | custom-source | 2025-02-12T13:47:23.212135 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf', 'application_number': 20272, 'submission_type': 'SUPPL ', 'submission_number': 63} |
12,417 |
... | custom-source | 2025-02-12T13:47:23.263305 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020280s077lbl.pdf', 'application_number': 20280, 'submission_type': 'SUPPL ', 'submission_number': 77} |
12,422 | NDA 20-297/S-013
Page 3
CO:LX
PRESCRIBING INFORMATION
COREG®
(carvedilol)
Tablets
DESCRIPTION
Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-
(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. It is a racemic mixture with
the following struc... | custom-source | 2025-02-12T13:47:23.765876 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020297s013lbl.pdf', 'application_number': 20297, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,423 | NDA 20-297/S-018
Page 3
CO:LXX
PRESCRIBING INFORMATION
COREG®
(carvedilol)
Tablets
DESCRIPTION
Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-
(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. It is a racemic mixture with
the following st... | custom-source | 2025-02-12T13:47:23.841135 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020297s018lbl.pdf', 'application_number': 20297, 'submission_type': 'SUPPL ', 'submission_number': 18} |
12,421 |
ATTENTION PHARMACIST: Detach “Patient’s Instructions for Use” from package
insert and dispense with the product.
Combivent® abcd
(ipratropium bromide and albuterol sulfate)
Inhalation Aerosol
Bronchodilator Aerosol
For Oral Inhalation Only
Rx only
Prescribing Information
... | custom-source | 2025-02-12T13:47:23.862596 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020291s026lbl.pdf', 'application_number': 20291, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,420 |
... | custom-source | 2025-02-12T13:47:23.997732 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020287s062lbl.pdf', 'application_number': 20287, 'submission_type': 'SUPPL ', 'submission_number': 62} |
12,426 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
| custom-source | 2025-02-12T13:47:24.675152 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/020298Orig1s001.pdf', 'application_number': 20298, 'submission_type': 'SUPPL ', 'submission_number': 1} |
12,425 |
... | custom-source | 2025-02-12T13:47:24.926578 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s033lbl.pdf', 'application_number': 20297, 'submission_type': 'SUPPL ', 'submission_number': 33} |
12,427 |
ORTHO-CEPT® TABLETS
(DESOGESTREL AND 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 age, particularly in women over 35 years of age, and... | custom-source | 2025-02-12T13:47:25.032775 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020301Orig1s025lbl.pdf', 'application_number': 20301, 'submission_type': 'SUPPL ', 'submission_number': 25} |
12,424 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
COREG safely and effectively. See full prescribing information for
COREG.
COREG® (carvedilol) tablets
Initial U.S. Approval: 1995
------------------RECENT MAJOR CHANGES -----------------------------------... | custom-source | 2025-02-12T13:47:25.077597 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020297s022lbl.pdf', 'application_number': 20297, 'submission_type': 'SUPPL ', 'submission_number': 22} |
12,428 |
Final clean 08 Aug 2008
ORTHO-CEPT® TABLETS
(desogestrel and ethinyl estradiol)
Patients should be counseled that this product does not protect against HIV
infection (AIDS) and other sexually transmitted diseases.
DESCRIPTION
ORTHO-CEPT Tablets provide an oral contr... | custom-source | 2025-02-12T13:47:25.330859 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020301s027lbl.pdf', 'application_number': 20301, 'submission_type': 'SUPPL ', 'submission_number': 27} |
12,431 | TRASYLOL®
(aprotinin injection)
01298181
12/03
Anaphylactic or anaphylactoid reactions are possible when Trasylol® is administered.
Hypersensitivity reactions are rare in patients with no prior exposure to aprotinin. The risk
of anaphylaxis is increased in patients who are re-exposed to aprotinin-containing pro... | custom-source | 2025-02-12T13:47:25.392460 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020304s009lbl.pdf', 'application_number': 20304, 'submission_type': 'SUPPL ', 'submission_number': 9} |
12,433 |
Roche logo
KYTRIL®
(granisetron hydrochloride)
INJECTION
Rx only
DESCRIPTION
KYTRIL (granisetron hydrochloride) Injection is an antinauseant and antiemetic agent.
Chemically it is endo-N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole
3-carboxamide hydrochloride with a molecular wei... | custom-source | 2025-02-12T13:47:25.654811 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020239s021,020305s014,021238s007lbl.pdf', 'application_number': 20305, 'submission_type': 'SUPPL ', 'submission_number': 14} |
12,432 | TRASYLOL tI
(aprotinin injection)
01298181
11/06
Trasyloi(j administration may cause fatal anaphylactic or anaphylactoid reactions.
Fatal reactions have occurred with an initial (test) dose as well as with any of the
components of the dose regimen. Fatal reactions have also occurred in situations
where the initial (tes... | custom-source | 2025-02-12T13:47:25.812615 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020304s022lbl.pdf', 'application_number': 20304, 'submission_type': 'SUPPL ', 'submission_number': 22} |
12,434 | custom-source | 2025-02-12T13:47:25.821533 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20306_FLUDEOXYGLUCOSE_prntlbl.pdf', 'application_number': 20306, 'submission_type': 'SUPPL ', 'submission_number': 5} | |
12,429 | ORTHO-CEPT® TABLETS
(DESOGESTREL AND ETHINYL ESTRADIOL)
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING
Cigarette smoking increases the risk of serious cardiovascular events from combination oral
contraceptive use. This risk increases with age, particularly in women over 35 years of age, and
with the number... | custom-source | 2025-02-12T13:47:25.888248 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020301s036lbl.pdf', 'application_number': 20301, 'submission_type': 'SUPPL ', 'submission_number': 36} |
12,438 |
univasc® tablets
(moexipril hydrochloride)
Rx only
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
•
When pregnancy is detected, discontinue univasc® as soon as possible.
•
Drugs that act directly on the renin-angiotensin system can cause in... | custom-source | 2025-02-12T13:47:26.148185 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s035lbl.pdf', 'application_number': 20312, 'submission_type': 'SUPPL ', 'submission_number': 35} |
12,435 |
DOCUMENT INFORMATION PAGE
DARRTS COMMUNICATION
This page is for FDA internal use only. Do NOT send this page with the letter.
Application #(s):
NDA 20312/S-031
CommunicationType:
Correspondence
Communication Group:
sNDA Action
Communication Name: Approval
Communication ID:
COR-SNDAACTION-05
Draf... | custom-source | 2025-02-12T13:47:26.232952 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020312s031lbl.pdf', 'application_number': 20312, 'submission_type': 'SUPPL ', 'submission_number': 31} |
12,437 |
univasc® tablets
(moexipril hydrochloride)
Rx only
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
•
When pregnancy is detected, discontinue univasc® as soon as possible.
•
Drugs that act directly on the renin-angiotensin system can cause in... | custom-source | 2025-02-12T13:47:26.306514 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s034lbl.pdf', 'application_number': 20312, 'submission_type': 'SUPPL ', 'submission_number': 34} |
12,436 |
univasc® tablets
(moexipril hydrochloride)
Rx only
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, univasc® should
be discontinued as soon as possible.... | custom-source | 2025-02-12T13:47:26.347979 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020312s033lbl.pdf', 'application_number': 20312, 'submission_type': 'SUPPL ', 'submission_number': 33} |
12,439 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
MIACALCIN nasal spray safely and effectively. See full prescribing ... | custom-source | 2025-02-12T13:47:26.605921 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020313s034lbl.pdf', 'application_number': 20313, 'submission_type': 'SUPPL ', 'submission_number': 34} |
12,441 | T2000-08
89008101
Vivelle®
estradiol transdermal system
Continuous delivery for twice-weekly application
Rx only
Prescribing Information
ESTROGENS
HAVE
BEEN
REPORTED
TO
INCREASE
THE
RISK
OF
ENDOMETRIAL CARCINOMA IN POSTMENOPAUSAL WOMEN.
Close clinical surveillance of all women taking estrogens is important. Ade... | custom-source | 2025-02-12T13:47:26.704546 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf', 'application_number': 20323, 'submission_type': 'SUPPL ', 'submission_number': 23} |
12,440 | NOT FOR INTRATHECAL USE
OXILAN® (Ioxilan Injection) 300 mgI/mL
OXILAN® (Ioxilan Injection) 350 mgI/mL
OXILAN® (Ioxilan Injection) 300 mgI/mL Pharmacy Bulk Package
OXILAN® (Ioxilan Injection) 350 mgI/mL Pharmacy Bulk Package
PHARMACY BULK PACKAGE IS NOT FOR DIRECT INFUSION
Nonionic Contrast Agents
DESCRIPTI... | custom-source | 2025-02-12T13:47:26.818868 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020316Orig1s028lbl.pdf', 'application_number': 20316, 'submission_type': 'SUPPL ', 'submission_number': 28} |
12,442 | Directions
• adults and children 12 years and over:
• to relieve symptoms, swallow 1 tablet with a glass
of water
• to prevent symptoms, swallow 1 tablet with a glass
of water at any time from 15 to 60 minutes before
eating food or drinking beverages that cause heartburn
• do not use more tha... | custom-source | 2025-02-12T13:47:27.120659 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20325se2-015_pepcid_lbl.pdf', 'application_number': 20325, 'submission_type': 'SUPPL ', 'submission_number': 15} |
12,445 | 1
NEUTREXIN® (trimetrexate glucuronate for injection)
Black Box
WARNINGS
NEUTREXIN (TRIMETREXATE GLUCURONATE FOR INJECTION) MUST BE USED
WITH CONCURRENT LEUCOVORIN (LEUCOVORIN PROTECTION) TO AVOID
POTENTIALLY SERIOUS OR LIFE-THREATENING TOXICITIES (SEE PRECAUTIONS
AND DOSAGE AND ADMINISTRATION).
DESCRIPTION
Neutrexin i... | custom-source | 2025-02-12T13:47:27.351786 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20326s11s13lbl.pdf', 'application_number': 20326, 'submission_type': 'SUPPL ', 'submission_number': 11} |
12,443 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:47:27.366753 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020325Orig1s024Lbl.pdf', 'application_number': 20325, 'submission_type': 'SUPPL ', 'submission_number': 24} |
12,446 |
1
NEUTREXIN® (trimetrexate glucuronate for injection)
1
2
Black Box
3
WARNINGS
4
NEUTREXIN (TRIMETREXATE GLUCURONATE FOR INJECTION) MUST BE USED
5
WITH CONCURRENT LEUCOVORIN (LEUCOVORIN PROTECTION) TO AVOID
6
POTENTIALLY SERIOUS OR LIFE-THREATENING TOXICITIES (SEE PRECAUTIONS
7
AND DOSAGE AND ADMINI... | custom-source | 2025-02-12T13:47:27.468694 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020326s015lbl.pdf', 'application_number': 20326, 'submission_type': 'SUPPL ', 'submission_number': 15} |
12,444 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:47:27.498862 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020325Orig1s030lbl.pdf', 'application_number': 20325, 'submission_type': 'SUPPL ', 'submission_number': 30} |
12,447 |
NDA 20-327; ISOVUE Multipack® (Iopamidol Injection)
Revised labeling to FDA_JULY-2012_CLEAN.doc
Bracco Diagnostics
F1/6065347 company logo
Isovue Multipack®
Pharmacy Bulk Package -
Not for Direct Infusion
ISOVUE Multipack®-250
lopamidol injec... | custom-source | 2025-02-12T13:47:27.736014 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020327s007lbl.pdf', 'application_number': 20327, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,449 |
----------
... | custom-source | 2025-02-12T13:47:27.861834 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020329s22lbl.pdf', 'application_number': 20329, 'submission_type': 'SUPPL ', 'submission_number': 22} |
12,448 | NDA 20-329/S-002
Page 3
GLUCOTROL XL®
(glipizide)
Extended Release Tablets
For Oral Use
Rx only
DESCRIPTION
Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class.
The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-
methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. The molecul... | custom-source | 2025-02-12T13:47:27.863453 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20329s2lbl.pdf', 'application_number': 20329, 'submission_type': 'SUPPL ', 'submission_number': 2} |
12,450 |
GLUCOTROL XL®
(glipizide)
Extended Release Tablets
For Oral Use
DESCRIPTION
Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class.
The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5
methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. T... | custom-source | 2025-02-12T13:47:27.976651 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020329s025lbl.pdf', 'application_number': 20329, 'submission_type': 'SUPPL ', 'submission_number': 25} |
12,451 |
GLUCOTROL XL®
(glipizide)
Extended Release Tablets
For Oral Use
DESCRIPTION
Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class.
The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5
methylpyra... | custom-source | 2025-02-12T13:47:28.228202 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020329s028lbl.pdf', 'application_number': 20329, 'submission_type': 'SUPPL ', 'submission_number': 28} |
12,454 |
... | custom-source | 2025-02-12T13:47:28.308707 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020330s029lbl.pdf', 'application_number': 20330, 'submission_type': 'SUPPL ', 'submission_number': 29} |
12,453 | NDA 20-330/S-018
NDA 20-330/S-019
Page 3
STERILE OPHTHALMIC GEL FORMING SOLUTION
TIMOPTIC-XE®
0.25% AND 0.5%
(TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION)
DESCRIPTION
TIMOPTIC-XE* (timolol maleate ophthalmic gel forming solution) is a non-selective beta-adrenergic receptor
blocking agent. Its chemical ... | custom-source | 2025-02-12T13:47:28.402828 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20330s018,019lbl.pdf', 'application_number': 20330, 'submission_type': 'SUPPL ', 'submission_number': 19} |
12,452 |
... | custom-source | 2025-02-12T13:47:28.669503 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020329s029lbl.pdf', 'application_number': 20329, 'submission_type': 'SUPPL ', 'submission_number': 29} |
12,455 | NDA 20-333/S-002
Page 4
AGRYLIN77
(anagrelide hydrochloride)
Capsules
DESCRIPTION
Name: AGRYLIN77 (anagrelide hydrochloride)
Dosage Form: 0.5 mg and 1 mg capsules for oral administration
Active Ingredient: AGRYLIN77 Capsules contain either 0.5 mg or 1 mg of anagrelide base (as anagrelide
hydrochloride).
Inactive Ingred... | custom-source | 2025-02-12T13:47:28.734963 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20333S2lbl.pdf', 'application_number': 20333, 'submission_type': 'SUPPL ', 'submission_number': 2} |
12,456 | NDA 20-333/S-008 & 009
Page 3
AGRYLIN®
(anagrelide hydrochloride)
Capsules
Rx only
DESCRIPTION
Name: AGRYLIN® (anagrelide hydrochloride)
Dosage Form: 0.5 mg and 1 mg capsules for oral administration
Active Ingredient: AGRYLIN® Capsules contain either 0.5 mg or 1 mg of anagrelide base (as
anagrelide hydr... | custom-source | 2025-02-12T13:47:28.921143 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s008,009lbl.pdf', 'application_number': 20333, 'submission_type': 'SUPPL ', 'submission_number': 9} |
12,457 | NDA 20-333/S-010
Page 3
AGRYLIN®
(anagrelide hydrochloride)
Capsules
Rx only
DESCRIPTION
Name: AGRYLIN® (anagrelide hydrochloride)
Dosage Form: 0.5 mg and 1 mg capsules for oral administration
Active Ingredient: AGRYLIN® Capsules contain either 0.5 mg or 1 mg of anagrelide base (as
anagrelide hydrochlorid... | custom-source | 2025-02-12T13:47:29.043344 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s010lbl.pdf', 'application_number': 20333, 'submission_type': 'SUPPL ', 'submission_number': 10} |
12,459 |
s
tr
uc
tu
ral formula
NDA 20-333/S-017
Page 3
AGRYLIN®
(anagrelide hydrochloride)
Capsules
Rx only
DESCRIPTION
Name: AGRYLIN® (anagrelide hydrochloride)
Dosage Form: 0.5 mg capsules for oral administration
Active Ingredient: AGRYLIN® Capsules contain 0.5 mg of anagrelide base... | custom-source | 2025-02-12T13:47:29.244419 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s017lbl.pdf', 'application_number': 20333, 'submission_type': 'SUPPL ', 'submission_number': 17} |
12,458 |
NDA 20-333/S-013
Page 3
AGRYLIN®
(anagrelide hydrochloride)
Capsules
Rx only
DESCRIPTION
Name: AGRYLIN® (anagrelide hydrochloride)
Dosage Form: 0.5 mg capsules for oral administration
Active Ingredient: AGRYLIN® Capsules contain 0.5 mg of anagrelide base (a... | custom-source | 2025-02-12T13:47:29.423920 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020333s013lbl.pdf', 'application_number': 20333, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,461 |
HIGHLIGHTS OF PRESCRIBING ... | custom-source | 2025-02-12T13:47:29.504595 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020333s022lbl.pdf', 'application_number': 20333, 'submission_type': 'SUPPL ', 'submission_number': 22} |
12,460 |
AGRYLIN®
(anagrelide hydrochloride)
Capsules
Rx only
DESCRIPTION
Name: AGRYLIN® (anagrelide hydrochloride)
Dosage Form: 0.5 mg capsules for oral administration
Active Ingredient: AGRYLIN® Capsules contain 0.5 mg of anagrelide base (as anagrelide
hydrochloride).
Inactive Ingredie... | custom-source | 2025-02-12T13:47:29.572608 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s019lbl.pdf', 'application_number': 20333, 'submission_type': 'SUPPL ', 'submission_number': 19} |
12,462 |
... | custom-source | 2025-02-12T13:47:29.753391 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020333s023lbl.pdf', 'application_number': 20333, 'submission_type': 'SUPPL ', 'submission_number': 23} |
12,463 | Flagyl® 375
metronidazole capsules
DESCRIPTION
Metronidazole is an oral synthetic antiproto-
zoal and antibacterial agent, 2-Methyl-5-nitro-
imidazole-1-ethanol, which has the following
structural formula:
Flagyl® 375 capsules contain 375 mg of
metronidazole USP. Inactive ingredients
include corn starch, magnesium stea... | custom-source | 2025-02-12T13:47:29.826715 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20334slr003_flagyl_lbl.pdf', 'application_number': 20334, 'submission_type': 'SUPPL ', 'submission_number': 3} |
12,464 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
| custom-source | 2025-02-12T13:47:29.849720 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020337s005lbl.pdf', 'application_number': 20337, 'submission_type': 'SUPPL ', 'submission_number': 5} |
12,467 |
Empirical formula
CSL Behring LLC
Stimate®
Package Insert
(desmopressin acetate)
Revised: April 2012
Page 1
1
CSL Behring
2
®
3
Stimate
4
(desmopressin acetate)
5
Nasal Spray, 1.5 mg/mL
6
7
Rx only
8
9
DESCRIPTION
10
Stimate® (desmopressin... | custom-source | 2025-02-12T13:47:30.040527 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020355s017lbl.pdf', 'application_number': 20355, 'submission_type': 'SUPPL ', 'submission_number': 17} |
12,465 |
... | custom-source | 2025-02-12T13:47:30.188173 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf', 'application_number': 20353, 'submission_type': 'SUPPL ', 'submission_number': 32} |
12,466 | CSL Behring
Stimate®
US Package Insert
(desmopressin acetate)
Revised: July 2007
Page 1
GRDC\RALABELING\COAGULATION\STIMATE\USA\PACKAGE INSERT, BLANK [80123ab1]\REV. 07/2007-RESPONSE TO CDER REQUEST DATED
20JUN07 and COMBINED ROOM TEMPERATURE STORAGE AND CSL NAME CHANGE
VERSION 7.0
Stimate®
... | custom-source | 2025-02-12T13:47:30.278809 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020355s007lbl.pdf', 'application_number': 20355, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,469 | 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 | 2025-02-12T13:47:30.387636 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf', 'application_number': 20358, 'submission_type': 'SUPPL ', 'submission_number': 34} |
12,468 | PRODUCT INFORMATION
1
WELLBUTRIN SR®
2
(bupropion hydrochloride)
3
Sustained-Release Tablets
4
5
“Information for the Patient” enclosed.
6
7
DESCRIPTION: WELLBUTRIN SR (bupropion hydrochloride), an antidepressant of the
8
aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptak... | custom-source | 2025-02-12T13:47:30.389473 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20358s27lbl.pdf', 'application_number': 20358, 'submission_type': 'SUPPL ', 'submission_number': 27} |
12,470 |
1
1
2
3
4
5
PRESCRIBING INFORMATION
WELLBUTRIN SR®
(bupropion hydrochloride)
Sustained-Release Tablets
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-... | custom-source | 2025-02-12T13:47:30.576557 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020358s043lbl.pdf', 'application_number': 20358, 'submission_type': 'SUPPL ', 'submission_number': 43} |
12,471 |
NDA 18-644/S-039
NDA 18-644/S-040
NDA 20-358/S-046
NDA 20-358/S-047
Page 33
PRESCRIBING INFORMATION
WELLBUTRIN SR®
(bupropion hydrochloride)
Sustained-Release Tablets
WARNING
Suicidality and Antidepressant Drugs
Use in Treating Psychiatric Disorde... | custom-source | 2025-02-12T13:47:30.840960 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020358s046s047lbl.pdf', 'application_number': 20358, 'submission_type': 'SUPPL ', 'submission_number': 46} |
12,472 |
NDA 18-644/S-039
NDA 18-644/S-040
NDA 20-358/S-046
NDA 20-358/S-047
Page 33
PRESCRIBING INFORMATION
WELLBUTRIN SR®
(bupropion hydrochloride)
Sustained-Release Tablets
WARNING
Suicidality and Antidepressant Drugs
Use in Treating Psychiatric Disorde... | custom-source | 2025-02-12T13:47:31.005292 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020358s046s047lbl.pdf', 'application_number': 20358, 'submission_type': 'SUPPL ', 'submission_number': 47} |
12,473 |
... | custom-source | 2025-02-12T13:47:31.344226 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020358s053s054lbl.pdf', 'application_number': 20358, 'submission_type': 'SUPPL ', 'submission_number': 53} |
12,474 |
... | custom-source | 2025-02-12T13:47:31.580772 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018644s048,020358s055lbl.pdf', 'application_number': 20358, 'submission_type': 'SUPPL ', 'submission_number': 55} |
12,477 |
T2006-71
Famvir®
(famciclovir)
Tablets
Rx only
PRESCRIBING INFORMATION
DESCRIPTION
Famvir® (famciclovir) contains famciclovir, an orally administered prodrug of the antiviral
agent penciclovir. Chemically, famciclovir is known as 2-[2-(2-amino-9H-purin-9-yl)ethyl]-
1,3-propanediol diacetate. It... | custom-source | 2025-02-12T13:47:31.674690 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s027s028lbl.pdf', 'application_number': 20363, 'submission_type': 'SUPPL ', 'submission_number': 27} |
12,475 |
... | custom-source | 2025-02-12T13:47:31.725592 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020358s056lbl.pdf', 'application_number': 20358, 'submission_type': 'SUPPL ', 'submission_number': 56} |
12,478 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
FAMVIR® safely and effectively. See f... | custom-source | 2025-02-12T13:47:31.861675 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020363s036lbl.pdf', 'application_number': 20363, 'submission_type': 'SUPPL ', 'submission_number': 36} |
12,479 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
FAMVIR® safely and effectivel... | custom-source | 2025-02-12T13:47:31.965410 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020363s037lbl.pdf', 'application_number': 20363, 'submission_type': 'SUPPL ', 'submission_number': 37} |
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