id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
14,346 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These ... | custom-source | 2025-02-12T13:52:14.671337 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s050lbl.pdf', 'application_number': 21085, 'submission_type': 'SUPPL ', 'submission_number': 53} |
14,345 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These ... | custom-source | 2025-02-12T13:52:14.675329 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s050lbl.pdf', 'application_number': 21085, 'submission_type': 'SUPPL ', 'submission_number': 50} |
14,347 |
... | custom-source | 2025-02-12T13:52:15.249111 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021085s057,021277s054lbl.pdf', 'application_number': 21085, 'submission_type': 'SUPPL ', 'submission_number': 57} |
14,348 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
AVELOX® safely and effectively. See full prescribing information for
AVELOX.
AVELOX (moxifloxacin hydrochloride) tablets, for oral use
AVELOX (moxifloxacin hydrochloride) injection, for intravenous use
Ini... | custom-source | 2025-02-12T13:52:15.396387 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021277Orig1s059,21085Orig1s063lbledt.pdf', 'application_number': 21085, 'submission_type': 'SUPPL ', 'submission_number': 63} |
14,350 |
1
1
2
3
4
5
6
7
8
9
PV 5195 AMP
ZYPREXA®
Olanzapine Tablets
ZYPREXA® ZYDIS®
Olanzapine Orally Disintegrating Tablets
ZYPREXA® IntraMuscular
Olanzapine for Injection
WARNING
10
Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly
11
patients with dementia-related psyc... | custom-source | 2025-02-12T13:52:15.846458 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s038,021086s020,021253s021lbl.pdf', 'application_number': 21086, 'submission_type': 'SUPPL ', 'submission_number': 20} |
14,349 |
1
PV 5192 AMP
1
ZYPREXA®
2
Olanzapine Tablets
3
4
ZYPREXA® ZYDIS®
5
Olanzapine Orally Disintegrating Tablets
6
7
ZYPREXA® IntraMuscular
8
Olanzapine for Injection
9
WARNING
10
Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly
11
patients with dementia-related p... | custom-source | 2025-02-12T13:52:16.060787 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021253s016,021086s016,020592s035lbl.pdf', 'application_number': 21086, 'submission_type': 'SUPPL ', 'submission_number': 16} |
14,352 |
1
PV 5197 AMP
ZYPREXA®
Olanzapine Tablets
ZYPREXA® ZYDIS®
Olanzapine Orally Disintegrating Tablets
ZYPREXA® IntraMuscular
Olanzapine for Injection
WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly
patients with dementia-related psychosis treated with atypical antip... | custom-source | 2025-02-12T13:52:16.478750 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf', 'application_number': 21086, 'submission_type': 'SUPPL ', 'submission_number': 23} |
14,351 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZYPREXA safely and effectively. See full pr... | custom-source | 2025-02-12T13:52:16.661850 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s039,021086s021lbl.pdf', 'application_number': 21086, 'submission_type': 'SUPPL ', 'submission_number': 21} |
14,353 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZYPREXA safely and effectively. See ful... | custom-source | 2025-02-12T13:52:16.720343 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s051,021086s030,021253s036lbl.pdf', 'application_number': 21086, 'submission_type': 'SUPPL ', 'submission_number': 30} |
14,354 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZYPREX... | custom-source | 2025-02-12T13:52:17.194962 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s052,021086s031,021253s037lbl.pdf', 'application_number': 21086, 'submission_type': 'SUPPL ', 'submission_number': 31} |
14,356 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZYPREXA safely and... | custom-source | 2025-02-12T13:52:17.453498 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s057,021086s036,021253s045lbl.pdf', 'application_number': 21086, 'submission_type': 'SUPPL ', 'submission_number': 36} |
14,355 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZYPREXA safely a... | custom-source | 2025-02-12T13:52:18.437230 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf', 'application_number': 21086, 'submission_type': 'SUPPL ', 'submission_number': 34} |
14,357 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZYPREXA safely and effectively. ... | custom-source | 2025-02-12T13:52:18.492441 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039lbl.pdf', 'application_number': 21086, 'submission_type': 'SUPPL ', 'submission_number': 39} |
14,358 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZYPREXA s... | custom-source | 2025-02-12T13:52:18.834348 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020592s063,021086s041lbl.pdf', 'application_number': 21086, 'submission_type': 'SUPPL ', 'submission_number': 41} |
14,359 |
1
•
Efficacy was established with Symbyax (olanzapine and
HIGHLIGHTS OF PRESCRIBING INFORMATION
fluoxetine in combina... | custom-source | 2025-02-12T13:52:18.976772 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020592s064,021086s042,021253s049lbl.pdf', 'application_number': 21086, 'submission_type': 'SUPPL ', 'submission_number': 42} |
14,360 | NDA 21-087/S-005
NDA 21-087/S-006
NDA 21-246/S-001
Page 3
TAMIFLU™
(oseltamivir phosphate)
CAPSULES
AND FOR ORAL SUSPENSION
DESCRIPTION: TAMIFLU (oseltamivir phosphate) is available as a capsule containing 75 mg
oseltamivir for oral use, in the form of oseltamivir phosphate, and as a powder for oral suspension,
which w... | custom-source | 2025-02-12T13:52:19.117535 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s5s6lbl.pdf', 'application_number': 21087, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,361 | NDA 21-087/S-005
NDA 21-087/S-006
NDA 21-246/S-001
Page 3
TAMIFLU™
(oseltamivir phosphate)
CAPSULES
AND FOR ORAL SUSPENSION
DESCRIPTION: TAMIFLU (oseltamivir phosphate) is available as a capsule containing 75 mg
oseltamivir for oral use, in the form of oseltamivir phosphate, and as a powder for oral suspension,
which w... | custom-source | 2025-02-12T13:52:19.121383 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s5s6lbl.pdf', 'application_number': 21087, 'submission_type': 'SUPPL ', 'submission_number': 6} |
14,362 | NDA 21-087/S-016
NDA 21-246/S-010
Page 3
TAMIFLU
(oseltamivir phosphate)
CAPSULES
AND FOR ORAL SUSPENSION
Rx only
DESCRIPTION
TAMIFLU (oseltamivir phosphate) is available as a capsule containing 75 mg oseltamivir for oral use,
in the form of oseltamivir phosphate, and as a powder for oral suspension, w... | custom-source | 2025-02-12T13:52:19.318537 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21087slr016,21246slr010_Tamiflu_lbl.pdf', 'application_number': 21087, 'submission_type': 'SUPPL ', 'submission_number': 16} |
14,363 | WARNING: KEEP OUT OF CHILDREN’S REACH
Store at 25°C (77°F); excursions
permitted to 15°– 30°C (59°– 86°F)
[see USP Controlled Room Temperature].
NDC 0004-0800-06
TAMIFLU
®75 mg
(oseltamivir phosphate) Capsules
Each capsule contains
oseltamivir phosphate
equivalent to 75 mg oseltamivir.
10 Capsules
USUAL DOSAGE: 1 Caps... | custom-source | 2025-02-12T13:52:19.467136 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s025lbl.pdf', 'application_number': 21087, 'submission_type': 'SUPPL ', 'submission_number': 25} |
14,364 | NDA 21-087/S-026
Page 2
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NDA 21-087/S-026
Page 3
This label may not be the la... | custom-source | 2025-02-12T13:52:19.503402 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s026lbl.pdf', 'application_number': 21087, 'submission_type': 'SUPPL ', 'submission_number': 26} |
14,365 | NDA 21-246/S-017
NDA 21-087/S-030
Page 3
TAMIFLU®
(oseltamivir phosphate)
CAPSULES
AND FOR ORAL SUSPENSION
Rx only
DESCRIPTION
TAMIFLU (oseltamivir phosphate) is available as a capsule containing 75 mg oseltamivir for oral use,
in the form of oseltamivir phosphate, and as a powder for oral suspension, whi... | custom-source | 2025-02-12T13:52:19.553008 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017_021087s030lbl.pdf', 'application_number': 21087, 'submission_type': 'SUPPL ', 'submission_number': 30} |
14,366 | NDA 21-087/S-033
NDA 21-246/S-021
Page 3
TAMIFLU®
(oseltamivir phosphate)
CAPSULES
AND FOR ORAL SUSPENSION
Rx only
DESCRIPTION
TAMIFLU (oseltamivir phosphate) is available as a capsule containing 75 mg oseltamivir for oral use,
in the form of oseltamivir phosphate, and as a powder for oral suspension, w... | custom-source | 2025-02-12T13:52:19.762129 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021087s033lbl.pdf', 'application_number': 21087, 'submission_type': 'SUPPL ', 'submission_number': 33} |
14,368 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
TAMIFLU safel... | custom-source | 2025-02-12T13:52:20.645900 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf', 'application_number': 21087, 'submission_type': 'SUPPL ', 'submission_number': 49} |
14,369 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
TAMIFLU safely and effectively. See full prescribing ... | custom-source | 2025-02-12T13:52:20.697743 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s055lbl.pdf', 'application_number': 21087, 'submission_type': 'SUPPL ', 'submission_number': 55} |
14,367 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
TAMIFLU safely and effectively. See full prescribing ... | custom-source | 2025-02-12T13:52:20.766256 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s045,021246s031lbl.pdf', 'application_number': 21087, 'submission_type': 'SUPPL ', 'submission_number': 45} |
14,370 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
TAMIFLU safely and effectively. See full p... | custom-source | 2025-02-12T13:52:20.874176 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s056_021246s039lbl.pdf', 'application_number': 21087, 'submission_type': 'SUPPL ', 'submission_number': 56} |
14,371 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
TAMIFLU safely and effectively. See full prescribing in... | custom-source | 2025-02-12T13:52:21.319776 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s059,021246s042lbl.pdf', 'application_number': 21087, 'submission_type': 'SUPPL ', 'submission_number': 59} |
14,372 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
TAMIFLU safely and effec... | custom-source | 2025-02-12T13:52:21.834872 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044lbl.pdf', 'application_number': 21087, 'submission_type': 'SUPPL ', 'submission_number': 61} |
14,375 |
structural formula
Viadur® (leuprolide acetate implant)
DESCRIPTION
Viadur® (leuprolide acetate implant) is a sterile nonbiodegradable, osmotically driven
miniaturized implant designed to deliver leuprolide acetate for 12 months at a controlled
rate (Figure A). Viadur® incorporates DUROS® technology. The ... | custom-source | 2025-02-12T13:52:22.171268 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021088s025lbl.pdf', 'application_number': 21088, 'submission_type': 'SUPPL ', 'submission_number': 25} |
14,373 |
... | custom-source | 2025-02-12T13:52:22.176350 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s065,021246s048lbl.pdf', 'application_number': 21087, 'submission_type': 'SUPPL ', 'submission_number': 65} |
14,374 | Patient Information About:
Viadur®
(leuprolide acetate implant)
Important Information for Patients Using Viadur® for the treatment of symptoms of advanced
prostate cancer.
Please read this information before you start using Viadur®. Each time another Viadur® is inserted,
check the patient information leaflet for any ne... | custom-source | 2025-02-12T13:52:22.214021 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021088s007lbl.pdf', 'application_number': 21088, 'submission_type': 'SUPPL ', 'submission_number': 7} |
14,376 | Cyclessa®
(desogestrel/ethinyl estradiol) Tablets
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other
sexually transmitted diseases.
DESCRIPTION
Cyclessa® (desogestrel/ethinyl estradiol) Tablets are a triphasic oral contraceptive containing two active
components, ... | custom-source | 2025-02-12T13:52:22.728573 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021090s004lbl.pdf', 'application_number': 21090, 'submission_type': 'SUPPL ', 'submission_number': 4} |
14,377 | 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 | 2025-02-12T13:52:22.758763 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21093lbl.pdf', 'application_number': 21093, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,379 |
ATACAND HCT®
(candesartan cilexetil –
hydrochlorothiazide)
TABLETS
USE IN PREGNANCY
When used in pregnancy during the second and third
trimesters, drugs that act directly on the renin-angiotensin
system can cause injury and even death to the developing
fetus. When pregnancy is d... | custom-source | 2025-02-12T13:52:22.812388 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021093s012lbl.pdf', 'application_number': 21093, 'submission_type': 'SUPPL ', 'submission_number': 12} |
14,378 | NDA 21-093/S-006
Page 3
ATACAND HCT 16-12.5
(candesartan cilexetil –
hydrochlorothiazide)
TABLETS
ATACAND HCT 32-12.5
(candesartan cilexetil –
hydrochlorothiazide)
TABLETS
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on the
renin-angiotensi... | custom-source | 2025-02-12T13:52:22.815832 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021093s006lbl.pdf', 'application_number': 21093, 'submission_type': 'SUPPL ', 'submission_number': 6} |
14,382 | September 21, 2000
Visicol
TM Tablets
(sodium phosphate monobasic monohydrate, USP,
sodium phosphate dibasic anhydrous, USP)
DESCRIPTION
Visicol (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic
anhydrous, USP) is a bowel evacuant used to clean the colon prior colonoscopy. Visicol Tablets
are... | custom-source | 2025-02-12T13:52:23.028134 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21097lbl.pdf', 'application_number': 21097, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,380 |
ATACAND HCT® 16-12.5
(candesartan cilexetil−hydrochlorothiazide)
TABLETS
ATACAND HCT® 32-12.5
(candesartan cilexetil−hydrochlorothiazide)
TABLETS
ATACAND HCT® 32–25
candesartan cilexetil-hydrochlorothiazide
WARNING: FE... | custom-source | 2025-02-12T13:52:23.354830 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021093s016lbl.pdf', 'application_number': 21093, 'submission_type': 'SUPPL ', 'submission_number': 16} |
14,384 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
YASMIN safely and effectively. ... | custom-source | 2025-02-12T13:52:23.472382 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s019lbl.pdf', 'application_number': 21098, 'submission_type': 'SUPPL ', 'submission_number': 19} |
14,383 | 1
Rx only
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED
DISEASES
YASMIN® 28 Tablets
(drospirenone and ethinyl estradiol)
DESCRIPTION
YASMIN provides an oral contraceptive regimen consisting of 21 active film coated
tablets each containing 3.0... | custom-source | 2025-02-12T13:52:23.752929 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021098s005lbl.pdf', 'application_number': 21098, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,381 |
ATACAND HCT® 16-12.5
(candesartan cilexetil−hydrochlorothiazide)
TABLETS, FOR ORAL USE
ATACAND HCT® 32-12.5
(candesartan cilexetil−hydrochlorothiazide)
TABLETS, FOR ORAL USE
ATACAND HCT® 32–25
(candesartan cilexetil-hydro... | custom-source | 2025-02-12T13:52:23.825725 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021093s019lbl.pdf', 'application_number': 21093, 'submission_type': 'SUPPL ', 'submission_number': 19} |
14,386 | Activella™
PHYSICIAN PACKAGE INSERT 4/10/2000
Page 1 of 29
4/10/2000
ACTIVELLA™
(estradiol/norethindrone acetate tablets)
1mg/0.5mg
Rx only
DESCRIPTION
Activella™ is a single tablet containing an estrogen, estradiol (E2), and a progestin,
norethindrone acetate (NETA), for oral administration. Each tablet cont... | custom-source | 2025-02-12T13:52:24.133909 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21103lbl.pdf', 'application_number': 21103, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,387 | NDA 21-105
Page 3
Rx only
Sulfamethoxazole and Trimethoprim Tablets, USP and Phenazopyridine Hydrochloride Tablets, USP
THE PRODUCTS ARE INTENDED ONLY FOR USE AS DESCRIBED. For use of the individual
components when dispensed as medications outside this combination package for treating urinary tract
infections (UTI), ... | custom-source | 2025-02-12T13:52:24.232799 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21105lbl.pdf', 'application_number': 21105, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,388 |
... | custom-source | 2025-02-12T13:52:24.631811 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021106s036lbl.pdf', 'application_number': 21106, 'submission_type': 'SUPPL ', 'submission_number': 36} |
14,389 | PRODUCT INFORMATION
LOTRONEX®
(alosetron hydrochloride)
Tablets
WARNING: Serious gastrointestinal adverse events, some fatal, have been reported with the
use of LOTRONEX. These events, including ischemic colitis and serious complications of
constipation, have resulted in hospitalization, blood transfusion, surgery, and... | custom-source | 2025-02-12T13:52:24.945216 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21107s5lbl.pdf', 'application_number': 21107, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,385 |
... | custom-source | 2025-02-12T13:52:24.947101 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021098s023lbl.pdf', 'application_number': 21098, 'submission_type': 'SUPPL ', 'submission_number': 23} |
14,390 | NDA 21-107/S-010
Page 3
PRESCRIBING INFORMATION
LOTRONEX®
(alosetron hydrochloride)
Tablets
WARNING: Infrequent but serious gastrointestinal adverse events have been reported with the use of LOTRONEX.
These events, including ischemic colitis and serious complications of constipation,... | custom-source | 2025-02-12T13:52:25.109109 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021107s010lbl.pdf', 'application_number': 21107, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,392 | NDA 21-107/S-012
Page 4
PRESCRIBING INFORMATION
LOTRONEX®
(alosetron hydrochloride)
Tablets
WARNING: Infrequent but serious gastrointestinal adverse events have been reported with the
use of LOTRONEX. These events, including ischemic colitis and serious complications of
constipation, have resulted in hosp... | custom-source | 2025-02-12T13:52:25.272110 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021107s012lbl.pdf', 'application_number': 21107, 'submission_type': 'SUPPL ', 'submission_number': 12} |
14,393 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LOTRONEX
safely and effectively. See fu... | custom-source | 2025-02-12T13:52:25.448030 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s016lbl.pdf', 'application_number': 21107, 'submission_type': 'SUPPL ', 'submission_number': 16} |
14,391 | NDA 21-107/S-011
Page 3
PRESCRIBING INFORMATION
LOTRONEX®
(alosetron hydrochloride)
Tablets
WARNING: Infrequent but serious gastrointestinal adverse events have been reported with the use of
LOTRONEX. These events, including ischemic colitis and serious complications of constipation, have resulted in
hospit... | custom-source | 2025-02-12T13:52:25.551555 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21107s011lbl.pdf', 'application_number': 21107, 'submission_type': 'SUPPL ', 'submission_number': 11} |
14,394 |
... | custom-source | 2025-02-12T13:52:25.759905 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021107s027lbl.pdf', 'application_number': 21107, 'submission_type': 'SUPPL ', 'submission_number': 27} |
14,396 |
RENOVA®
(tretinoin cream)
0.02%
FOR TOPICAL USE ON THE FACE. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
DESCRIPTION:
RENOVA (tretinoin cream) 0.02% contains the active ingredient tretinoin in a cream base. Tretinoin is a
yellow-to-light orange crystalline powder having a characteristic floral odor.... | custom-source | 2025-02-12T13:52:25.831520 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21108s1lbl.pdf', 'application_number': 21108, 'submission_type': 'SUPPL ', 'submission_number': 1} |
14,395 | 1
RENOVA®
1
(tretinoin cream)
2
0.02%
3
4
FOR TOPICAL USE ON THE FACE. NOT FOR OPHTHALMIC, ORAL, OR
5
INTRAVAGINAL USE.
6
7
8
DESCRIPTION:
9
10
RENOVA (tretinoin cream) 0.02% contains the active ingredient tretinoin in a cream
11
base. Tretinoin is a yellow to light orange crystalline powder having a characteristic
12... | custom-source | 2025-02-12T13:52:25.881538 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21108lbl.pdf', 'application_number': 21108, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,397 | 1
Rapamune
(sirolimus)
Oral Solution and Tablets
WARNING:
Increased susceptibility to infection and the possible development of lymphoma may result from
immunosuppression. Only physicians experienced in immunosuppressive therapy and
management of renal transplant patients should use Rapamune. Patients receiving the d... | custom-source | 2025-02-12T13:52:26.022230 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021083s006lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 4} |
14,398 | CI-7713
Rapamune
05/02/02
1
Rapamune®
(sirolimus)
Oral Solution and Tablets
WARNING:
Increased susceptibility to infection and the possible development of lymphoma may result from
immunosuppression. Only physicians experienced in immunosuppressive therapy and
management of renal transplant patients should use Rapamune®... | custom-source | 2025-02-12T13:52:26.101401 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,399 | CI-7713
Rapamune
05/02/02
1
Rapamune®
(sirolimus)
Oral Solution and Tablets
WARNING:
Increased susceptibility to infection and the possible development of lymphoma may result from
immunosuppression. Only physicians experienced in immunosuppressive therapy and
management of renal transplant patients should use Rapamune®... | custom-source | 2025-02-12T13:52:26.192270 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,401 | 1
Rapamune
(sirolimus)
Oral Solution and Tablets
WARNING:
Increased susceptibility to infection and the possible development of lymphoma may result from
immunosuppression. Only physicians experienced in immunosuppressive therapy and
management of renal transplant patients should use Rapamune. Patients receiving the... | custom-source | 2025-02-12T13:52:26.426953 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21110slr013,21083slr014_Rapamune_lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 14} |
14,402 |
1
Rapamune
(sirolimus)
Oral Solution and Tablets
only
This product’s label may have been revised after this insert was
used in production. For further product information and current
package insert, please visit www.wyeth.com or call our medical
communications department toll-free at 1-800-934-5556.
... | custom-source | 2025-02-12T13:52:26.791567 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,028lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 28} |
14,400 | 1
Rapamune
(sirolimus)
Oral Solution and Tablets
WARNING:
Increased susceptibility to infection and the possible development of lymphoma may result from
immunosuppression. Only physicians experienced in immunosuppressive therapy and
management of renal transplant patients should use Rapamune. Patients receiving the... | custom-source | 2025-02-12T13:52:26.825059 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21110slr013,21083slr014_Rapamune_lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 13} |
14,403 | NDA 21-083/S-021, S-022
NDA 21-110/S-030, S-031
Page 4
Rapamune®
(sirolimus)
Oral Solution and Tablets
only
This product’s label may have been revised after this insert was
used in production. For further product information and current
package insert, please visit www.wyeth.com or call our medical
co... | custom-source | 2025-02-12T13:52:26.911645 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s022,023,021110s030,031lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 31} |
14,404 | Rapamune
(sirolimus)
Oral Solution and Tablets
only
This product’s label may have been revised after this insert was
used in production. For further product information and current
package insert, please visit www.wyeth.com or call our medical
communications department toll-free at 1-800-934-5556.
WA... | custom-source | 2025-02-12T13:52:27.019863 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s024s025,021110s032s034lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 34} |
14,405 | NDA 21-083/S-026
NDA 21-110/S-035
Page 3
Rapamune®
(sirolimus)
Oral Solution and Tablets
Rx only
This product's label may have been revised after this insert was used in production.
For further product information and current package insert, please visit
www.wyeth.com or call our medical communication... | custom-source | 2025-02-12T13:52:27.206034 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s026,021110s035lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 35} |
14,407 | NDA 21-083/S-030
NDA 21-110/S-038
Page 3
Rapamune®
(sirolimus)
Oral Solution and Tablets
Rx only
This product's label may have been revised after this insert was used in production.
For further product information and current package insert, please visit
www.wyeth.com or call our medical communicati... | custom-source | 2025-02-12T13:52:27.355496 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s030,021110s038lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 38} |
14,406 | NDA 21-083/S-028
NDA 21-110/S-036
Page 5
Rapamune®
(sirolimus)
Oral Solution and Tablets
only
This product’s label may have been revised after this insert was
used in production. For further product information and current
package insert, please visit www.wyeth.com or call our medical
communications d... | custom-source | 2025-02-12T13:52:27.539726 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s028,021110s036lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 36} |
14,408 | NDA 21-083/S-034
NDA 21-110/S-045
Page 4
Rapamune®
(sirolimus)
Oral Solution and Tablets
Rx only
WARNING:
Increased susceptibility to infection and the possible development of lymphoma may result from
immunosuppression. Only physicians experienced in immunosuppressive therapy and management of
renal tran... | custom-source | 2025-02-12T13:52:27.679232 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s034,021110s045lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 45} |
14,409 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Rapamune safely and effectively. See fu... | custom-source | 2025-02-12T13:52:28.038694 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s041,021110s051lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 51} |
14,410 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
RAPAMUNE safely and effectively.
See full prescribing information for RAPAMUNE.
RAPAMUNE (sirolimus) ORAL SOLUTION AND TABLETS
Initial U.S. Approval: 1999
WARNING: IMMUNOSUPPRESSION, USE IS NOT
... | custom-source | 2025-02-12T13:52:28.589032 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s045,021110s052lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 52} |
14,411 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Rapamune safely and effectively. See full prescribing information for
Rapamune.
RAPAMUNE (sirolimus) ORAL SOLUTION AND TABLETS
Initial U.S. Approval: 1999
WARNING: IMMUNOSUPPRESSION, USE IS NOT
RECOMMENDED IN ... | custom-source | 2025-02-12T13:52:28.639386 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s054lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 53} |
14,412 |
NDA 21-083/S-046
NDA 21-110/S-056
Page 4
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights... | custom-source | 2025-02-12T13:52:28.744521 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s046,021110s056lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 56} |
14,413 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Rapamune safely and effectively. See full prescribing information for
Rapamune.
RAPAMUNE (sirolimus) ORAL SOLUTION AND TABLETS
Initial U.S. Approval: 1999
WARNING: IMMUNOSUPPRESSION, USE IS NOT
RECOMMENDED IN ... | custom-source | 2025-02-12T13:52:28.993278 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021083s053,021110s067lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 67} |
14,415 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Rapamune safely and effectively. See full prescribing information for
Rapamune.
RAPAMUNE (sirolimus) ORAL SOLUTION AND TABLETS
Initial U.S. Approval: 1999
WARNING: IMMUNOSUPPRESSION, USE IS NOT
RECOMMENDED IN ... | custom-source | 2025-02-12T13:52:29.277822 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s056,021110s074lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 74} |
14,416 | NDA 21-112
Page 4
TRI-LUMA™ Cream
(fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%)
For External Use Only
Not for Ophthalmic Use
Rx only
DESCRIPTION
TRI-LUMA™ Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) contains fluocinolone
acetonide, USP, hydroquinone, USP,... | custom-source | 2025-02-12T13:52:29.328968 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21112lbl.pdf', 'application_number': 21112, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,414 |
... | custom-source | 2025-02-12T13:52:29.586249 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s055,021110s073lbl.pdf', 'application_number': 21110, 'submission_type': 'SUPPL ', 'submission_number': 73} |
14,417 |
___________________________... | custom-source | 2025-02-12T13:52:29.673710 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021112s009lbl.pdf', 'application_number': 21112, 'submission_type': 'SUPPL ', 'submission_number': 9} |
14,418 |
company logo
PMD-P08
PAMIDRONATE DISODIUM INJECTION
PAMIDRONATE DISODIUM FOR INJECTION, USP
For Intravenous Infusion
Rx ONLY
DESCRIPTION
Pamidronate Disodium Injection is a bone-resorption inhibitor available in 30 mg vials
for intravenous administration. E... | custom-source | 2025-02-12T13:52:29.814666 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021113s012lbl.pdf', 'application_number': 21113, 'submission_type': 'SUPPL ', 'submission_number': 12} |
14,419 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:52:29.907407 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021113s017lbl.pdf', 'application_number': 21113, 'submission_type': 'SUPPL ', 'submission_number': 17} |
14,420 | 1
FINAL PACKAGE INSERT TEXT
BETAXON
(levobetaxolol hydrochloride ophthalmic suspension)
0.5% as base
DESCRIPTION: BETAXON (levobetaxolol hydrochloride ophthalmic suspension) 0.5%
contains levobetaxolol hydrochloride, a cardioselective beta-adrenergic receptor blocking agent,
in a sterile resin suspension formulati... | custom-source | 2025-02-12T13:52:30.110866 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21114lbl.pdf', 'application_number': 21114, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,421 |
___________________________________________________________________________________________________________
________... | custom-source | 2025-02-12T13:52:30.200761 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021114s003lbl.pdf', 'application_number': 21114, 'submission_type': 'SUPPL ', 'submission_number': 3} |
14,422 | NDA 21-119 Visudyne (verteporfin for injection)
1 of 12
VISUDYNE™
(verteporfin for injection)
DESCRIPTION
VISUDYNE™ (verteporfin for injection) is a light activated drug used in photodynamic therapy.
The finished drug product is a lyophilized dark green cake. Verteporfin is a 1:1 mixture of two
regioisomers (I and II)... | custom-source | 2025-02-12T13:52:30.202442 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21119lbl.pdf', 'application_number': 21119, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,424 | NDA 21-119/S-003
Page 3
VISUDYNE™
(verteporfin for injection)
DESCRIPTION
VISUDYNE™ (verteporfin for injection) is a light activated drug used in photodynamic therapy. The
finished drug product is a lyophilized dark green cake. Verteporfin is a 1:1 mixture of two regioisomers (I
and II), represente... | custom-source | 2025-02-12T13:52:30.520214 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119s3lbl.pdf', 'application_number': 21119, 'submission_type': 'SUPPL ', 'submission_number': 3} |
14,425 | NDA 21-119/S-005
Page 3
Vial Label
NDC 58768-150-15
(Visudyne Logo)
Visudyne®
verteporfin
for injection
15 mg
(Novartis Logo)
Store at 20-25°C (68-77°F)
QLT PhotoTherapeutics, Inc.
Seattle, WA 98101
L4124-C
Co-Developed and
Distributed by:
Novartis Ophthalmics, Inc.
Duluth, GA... | custom-source | 2025-02-12T13:52:30.541699 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119slr005_visudyne_lbl.pdf', 'application_number': 21119, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,426 |
NDA 21-119/S-013
Page 3
VISUDYNE®
(VERTEPORFIN FOR INJECTION)
DESCRIPTION
VISUDYNE® (verteporfin for injection) is a light activated drug used in photodynamic therapy. The
finished drug product is a lyophilized dark green cake. Verteporfin is a 1:1 mixture of two
regioisomers (I ... | custom-source | 2025-02-12T13:52:30.684015 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021119s013lbl.pdf', 'application_number': 21119, 'submission_type': 'SUPPL ', 'submission_number': 13} |
14,428 |
NDA 21-119/S-022
Page 3
VISUDYNE®
(VERTEPORFIN FOR INJECTION)
DESCRIPTION
VISUDYNE® (verteporfin for injection) is a light activated drug used in photodynamic therapy.
The finished drug product is a lyophilized dark green cake. Verteporfin is a 1:1 mixture of two
regioi... | custom-source | 2025-02-12T13:52:30.831732 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021119s022lbl.pdf', 'application_number': 21119, 'submission_type': 'SUPPL ', 'submission_number': 22} |
14,430 | (FINALAPLBL.DOC)
FINAL DRAFT LABELING FOR CONCERTATM EXTENDED-RELEASE TABLETS
Attachment to Approval Letter
CONCERTA CII
CONCERTA (methylphenidate HCl) Extended-release Tablets
DESCRIPTION
CONCERTAJ is a central nervous system (CNS) stimulant.
CONCERTAJ is available in two tablet strengths. Each extended-
release ta... | custom-source | 2025-02-12T13:52:30.940418 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21121lbl.pdf', 'application_number': 21121, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,427 | NDA 21-119/S-021
Page 3
VISUDYNE®
(VERTEPORFIN FOR INJECTION)
CC#35324
DESCRIPTION
VISUDYNE® (verteporfin for injection) is a light activated drug used in photodynamic therapy. The
finished drug product is a lyophilized dark green cake. Verteporfin is a 1:1 mixture of two
regioisomers (I and II), repres... | custom-source | 2025-02-12T13:52:31.004287 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021119s021lbl.pdf', 'application_number': 21119, 'submission_type': 'SUPPL ', 'submission_number': 21} |
14,429 | custom-source | 2025-02-12T13:52:31.018116 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21120.pdf_Novantrone_Prntlbl.pdf', 'application_number': 21120, 'submission_type': 'ORIG ', 'submission_number': 1} | |
14,431 | Page 1
CONCERTA® (methylphenidate HCl)
Extended-release Tablets CII
DESCRIPTION
CONCERTA® is a central nervous system (CNS) stimulant. CONCERTA® is available in four tablet
strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or
54 mg of methylphenidate HCl USP and... | custom-source | 2025-02-12T13:52:31.180756 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21121s008lbl.pdf', 'application_number': 21121, 'submission_type': 'SUPPL ', 'submission_number': 8} |
14,432 | CONCERTA®
(methylphenidate HCl)
Extended-release Tablets CII
DESCRIPTION
CONCERTA® is a central nervous system (CNS) stimulant. CONCERTA® is
available in four tablet strengths. Each extended-release tablet for once-a-day oral
administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is
design... | custom-source | 2025-02-12T13:52:31.256943 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021121s014lbl.pdf', 'application_number': 21121, 'submission_type': 'SUPPL ', 'submission_number': 14} |
14,433 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
CONCERTA safely and effectively. See full prescribing information for
CONCERTA .
CONCERTA® (methylphenidate HCl) Extended-Release Tablets CI... | custom-source | 2025-02-12T13:52:31.580016 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021121s015s017lbl.pdf', 'application_number': 21121, 'submission_type': 'SUPPL ', 'submission_number': 15} |
14,434 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
CONCERTA safely and effectively. See full prescribing information for
CONCERTA .
CONCERTA® (methylphenidate HCl) Extended-Release Tablets CI... | custom-source | 2025-02-12T13:52:31.698186 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021121s015s017lbl.pdf', 'application_number': 21121, 'submission_type': 'SUPPL ', 'submission_number': 17} |
14,436 |
[ HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
CONCERTA® safely and effectively. See full prescrib... | custom-source | 2025-02-12T13:52:31.866037 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021121s026s027lbl.pdf', 'application_number': 21121, 'submission_type': 'SUPPL ', 'submission_number': 27} |
14,435 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
CONCERTA® safely and effectively. See fu... | custom-source | 2025-02-12T13:52:32.236590 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021121s022lbl.pdf', 'application_number': 21121, 'submission_type': 'SUPPL ', 'submission_number': 22} |
14,437 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
CONCERTA safely and effectively. See full pr... | custom-source | 2025-02-12T13:52:32.466030 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021121s029lbl.pdf', 'application_number': 21121, 'submission_type': 'SUPPL ', 'submission_number': 29} |
14,439 | NDA 20-281/S-030
Page 1
ULTRAM® (tramadol hydrochloride tablets)
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
hydrochloride. Its structural formula is:
Th... | custom-source | 2025-02-12T13:52:32.499103 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20281slr030,21123slr001_Ultram_lbl.pdf', 'application_number': 21123, 'submission_type': 'SUPPL ', 'submission_number': 1} |
14,438 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
CONCERTA safely an... | custom-source | 2025-02-12T13:52:32.577854 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021121s032lbl.pdf', 'application_number': 21121, 'submission_type': 'SUPPL ', 'submission_number': 32} |
14,440 |
structural formula
ULTRACET®
(tramadol hydrochloride/acetaminophen)
Tablets
Full Prescribing Information
HEPATOTOXICITY
ULTRACET® contains tramadol HCl and acetaminophen. Acetaminophen has
been associated with cases of acute liver failure, at times resulting in liver
transplant and de... | custom-source | 2025-02-12T13:52:32.796825 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021123s005lbl.pdf', 'application_number': 21123, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,443 | BASIS FOR APPROVAL May 16, 2000
Page 1
Azelastine Hydrochloride Ophthalmic Solution, 0.05%
NDA # 21-127
OPTIVAR™
azelastine hydrochloride ophthalmic solution, 0.05%
DESCRIPTION
OPTIVAR™ (azelastine hydrochloride ophthalmic solution) 0.05% is a sterile ophthalmic
solution containing azelastine hydrochloride, a relative... | custom-source | 2025-02-12T13:52:32.892765 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21127lbl.pdf', 'application_number': 21127, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,441 |
ULTRACET
(tramadol hydrochloride/acetaminophen)
Tablets
Full Prescribing Information
HEPATOTOXICITY
ULTRACET® contains tramadol HCl and acetaminophen. Acetaminophen has
been associated with cases of acute liver f... | custom-source | 2025-02-12T13:52:33.028808 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021123s008lbl.pdf', 'application_number': 21123, 'submission_type': 'SUPPL ', 'submission_number': 8} |
14,442 | 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 | 2025-02-12T13:52:33.044183 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21124lbl.pdf', 'application_number': 21124, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,444 | NDA 21-127/S-007 & S-008
Page 3
OPTIVAR®
(azelastine hydrochloride ophthalmic solution) 0.05%
DESCRIPTION
OPTIVAR® (azelastine hydrochloride ophthalmic solution), 0.05% is a sterile ophthalmic solution
containing azelastine hydrochloride, a relatively selective H1-receptor antagonist for topical
adm... | custom-source | 2025-02-12T13:52:33.139520 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21127slr007,008_optivar_lbl.pdf', 'application_number': 21127, 'submission_type': 'SUPPL ', 'submission_number': 8} |
14,446 | NDA 20-235/S-029; NDA 20-882/S-015; NDA 21-129/S-016
FDA Approved Labeling Text dated February 2005
Page 1 of 29
Neurontin® (gabapentin) Capsules
Neurontin® (gabapentin) Tablets
Neurontin®(gabapentin) Oral Solution
DESCRIPTION
Neurontin® (gabapentin) Capsules, Neurontin® (gabapentin) Tablets, and Neu... | custom-source | 2025-02-12T13:52:33.281394 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20235s029,20882s015,21129s016lbl.pdf', 'application_number': 21129, 'submission_type': 'SUPPL ', 'submission_number': 16} |
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