id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
11,509 | NDA 19-462/S-030
NDA 19-527/S-024
NDA 20-752/S-005
Page 3
PEPCID®
(FAMOTIDINE) TABLETS
PEPCID®
(FAMOTIDINE) FOR ORAL SUSPENSION
PEPCID RPD®
(FAMOTIDINE) ORALLY DISINTEGRATING TABLETS
DESCRIPTION
The active ingredient in PEPCID* (famotidine) is a histamine H2-receptor antagonist. Famotidine is N′-
(aminos... | custom-source | 2025-02-12T13:45:25.326510 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf', 'application_number': 19462, 'submission_type': 'SUPPL ', 'submission_number': 30} |
11,510 | NDA 19-462/S-034
NDA 19-510/S-031
NDA 20-249/S-013
Page 3
PEPCID®
(FAMOTIDINE) TABLETS
PEPCID®
(FAMOTIDINE) FOR ORAL SUSPENSION
DESCRIPTION
The active ingredient in PEPCID* (famotidine) is a histamine H2-receptor antagonist. Famotidine is N′-
(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methy... | custom-source | 2025-02-12T13:45:25.427475 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,020249s013lbl.pdf', 'application_number': 19462, 'submission_type': 'SUPPL ', 'submission_number': 34} |
11,512 | PEEL OPEN TO READ COMPLETE
DIRECTIONS AND WARNINGS
BEFORE PURCHASE
Do not use if printed inner or outer
neckband is broken or missing.
www.imodium.com
NDC 50580-134-04
4 f l oz
(120 mL)
Controls the symptoms
of diarrhea
Mint Flavor
Loperamide HCl, Anti Diarrheal
1 mg per 7.5 mL
®
A-D
Anti-Diarrheal
Oral Solu ion
Lope... | custom-source | 2025-02-12T13:45:26.024084 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019487Orig1s028lbl.pdf', 'application_number': 19487, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,513 | NDA 19-500/S-010
Page 3
C98-38 (Rev. 7/2002)
667753
Lamprene®
clofazimine
Soft Gelatin Capsules
Prescribing Information
Rx only
DESCRIPTION
Lamprene, clofazimine, is an antileprosy agent available as soft gelatin capsules for oral
administration. Each capsule contains 50 mg of micronized clofazim... | custom-source | 2025-02-12T13:45:26.289261 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19500slr010_lamprene_lbl.pdf', 'application_number': 19500, 'submission_type': 'SUPPL ', 'submission_number': 10} |
11,514 | LOT/EXP
Women’s Rogaine
® is for women who have a general
thinning of hair on the top of the scalp as shown.
Women’s Rogaine
® has been shown to regrow
hair in women with the following degrees of
thinning hair or hair loss.
Do not use if you have patchy
hair loss as shown above.
Dist: Johnson & Johnson Healthcare ... | custom-source | 2025-02-12T13:45:26.433755 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019501Orig1s029lbl.pdf', 'application_number': 19501, 'submission_type': 'SUPPL ', 'submission_number': 29} |
11,515 | NDC 65726-144-15
AXID
®
(nizatidine)
Capsules, USP
1514M400
Rx only
60 PULVULES
®
Usual Adult Dose:
See accompanying literature
for dosage.
Keep tightly closed.
Store at controlled room
temperature 20° to 25°C
(68° to 77°F) [see USP].
Manufactured for:
Reliant Pharmaceuticals, Inc.
Liberty Corner, NJ 07938
by:
Patheo... | custom-source | 2025-02-12T13:45:26.655818 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019508s033lbl.pdf', 'application_number': 19508, 'submission_type': 'SUPPL ', 'submission_number': 33} |
11,516 | 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 | 2025-02-12T13:45:26.809743 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19510s28lbl20249s11lbl.pdf', 'application_number': 19510, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,517 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:45:26.834213 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19532s12lbl.pdf', 'application_number': 19532, 'submission_type': 'SUPPL ', 'submission_number': 12} |
11,511 | PEEL OPEN TO READ COMPLETE
DIRECTIONS AND WARNINGS
BEFORE PURCHASE
Tamper evident s atement
www.imodium.com
NDC 50580 134 04
4 f l oz
( 20 ml)
Controls the symptoms
of diarrhea
Mint Flavor
Lop
d HC Ant D
h
1
g p
5
L
®
A-D
the symptoms
ea
Mint F
Anti-Diarrheal
nt Flavor
Liquid
Loperamide HCl Anti Diarrheal
mg pe... | custom-source | 2025-02-12T13:45:27.547805 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019487Orig1s027lbl.pdf', 'application_number': 19487, 'submission_type': 'SUPPL ', 'submission_number': 27} |
11,528 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
DIPROLENE AF Cream safely and effectively. See full prescribing
information for DIPROLENE AF Cream.
DIPROLENE®
AF
(augmented
betamethasone
dipro... | custom-source | 2025-02-12T13:45:27.648668 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019555s033lbl.pdf', 'application_number': 19555, 'submission_type': 'SUPPL ', 'submission_number': 33} |
11,529 | Rx only
VePesid
®
(etoposide)
For Injection and Capsules
DESCRIPTION
VePesid® (etoposide) (also commonly known as VP-16) is a semisynthetic derivative of
podophyllotoxin used in the treatment of certain neoplastic diseases. It is
4'-demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside]. It is very
sol... | custom-source | 2025-02-12T13:45:27.651870 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/019557s028lbl.pdf', 'application_number': 19557, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,530 |
7825248
1
TABLETS
PRINIVIL®
(LISINOPRIL)
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause
injury and even death to the developing fetus. When pregnancy is detected, PRINIVIL should
be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal M... | custom-source | 2025-02-12T13:45:27.733853 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-043_prinivil_lbl.pdf', 'application_number': 19558, 'submission_type': 'ORIG ', 'submission_number': 1} |
11,531 |
7825248
1
TABLETS
PRINIVIL®
(LISINOPRIL)
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause
injury and even death to the developing fetus. When pregnancy is detected, PRINIVIL should
be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal M... | custom-source | 2025-02-12T13:45:27.980310 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-043_prinivil_lbl.pdf', 'application_number': 19558, 'submission_type': 'SUPPL ', 'submission_number': 43} |
11,533 |
company logo
USPI-T-05211205R007
TABLETS
PRINIVIL®
(LISINOPRIL)
WARNING: Fetal Toxicity
When pregnancy is detected, discontinue PRINIVIL as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to the
developing fetus. See ... | custom-source | 2025-02-12T13:45:28.131747 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019558s055lbl.pdf', 'application_number': 19558, 'submission_type': 'SUPPL ', 'submission_number': 55} |
11,532 |
company logo
9763206
TABLETS
PRINIVIL®
(LISINOPRIL)
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury
and even death to the developing fetus. When pregnancy is detected, PRINIVIL should be
discontinued as soon as possible. S... | custom-source | 2025-02-12T13:45:28.144635 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019558Orig1s054Lbl_REPLACEMENTS.pdf', 'application_number': 19558, 'submission_type': 'SUPPL ', 'submission_number': 54} |
11,534 |
company logo
USPI-T-05211212R008
TABLETS
PRINIVIL®
(LISINOPRIL)
WARNING: FETAL TOXICITY
•
When pregnancy is detected, discontinue PRINIVIL as soon as possible.
•
Drugs that act directly on the renin-angiotensin system can cause injury and death to the
developing fetus. See WAR... | custom-source | 2025-02-12T13:45:28.175544 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019558s056lbl.pdf', 'application_number': 19558, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,537 |
chem
i
c
a
l
st
ru
ct
ur
e
DERMATOP® Ointment
(prednicarbate ointment) 0.1%
FOR DERMATOLOGIC USE ONLY.
NOT FOR USE IN EYES.
DESCRIPTION
DERMATOP® Ointment (prednicarbate ointment) 0.1% contains the non-halogenated
prednisolone derivative prednicarbate. The topical corticosteroids constitute... | custom-source | 2025-02-12T13:45:28.342490 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019568s014lbl.pdf', 'application_number': 19568, 'submission_type': 'SUPPL ', 'submission_number': 14} |
11,536 | NDA 19-568/S-008
Page 3
Prescribing Information as of February 2004(a).
DERMATOP Ointment
(prednicarbate ointment) 0.1%
FOR DERMATOLOGIC USE ONLY.
NOT FOR USE IN EYES.
DESCRIPTION
DERMATOP Ointment (prednicarbate ointment) 0.1% contains the non-halogenated prednisolone
derivative prednicarbate. The t... | custom-source | 2025-02-12T13:45:28.428930 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19568scf008_dermatop_lbl.pdf', 'application_number': 19568, 'submission_type': 'SUPPL ', 'submission_number': 8} |
11,535 |
... | custom-source | 2025-02-12T13:45:28.637076 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s057lbl.pdf', 'application_number': 19558, 'submission_type': 'SUPPL ', 'submission_number': 57} |
11,539 | TERAZOL
7(terconazole) Vaginal Cream 0.4%
TERAZOL
3(terconazole) Vaginal Cream 0.8%
TERAZOL® 3 (terconazole) Vaginal Suppositories 80 mg
DESCRIPTION
TERAZOL® 7(terconazole) Vaginal Cream 0.4% is a white to off-white, water washable
cream for intravaginal administration containing 0.4% of the antifungal agent
terc... | custom-source | 2025-02-12T13:45:28.669905 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf', 'application_number': 19579, 'submission_type': 'SUPPL ', 'submission_number': 16} |
11,541 |
TERAZOL® 7 VAGINAL CREAM 0.4%
(terconazole)
TERAZOL® 3 VAGINAL CREAM 0.8%
(terconazole)
TERAZOL® 3 VAGINAL SUPPOSITORIES 80 MG
(terconazole)
DESCRIPTION
TERAZOL® 7 (terconazole) Vaginal Cream 0.4% is a white to off-white, water
... | custom-source | 2025-02-12T13:45:28.954116 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019579s037,019641s030,019964s032lbl.pdf', 'application_number': 19579, 'submission_type': 'SUPPL ', 'submission_number': 37} |
11,540 | TERAZOL 7(terconazole) Vaginal Cream 0.4%
TERAZOL 3(terconazole) Vaginal Cream 0.8%
TERAZOL® 3 (terconazole) Vaginal Suppositories 80 mg
DESCRIPTION
TERAZOL® 7(terconazole) Vaginal Cream 0.4% is a white to off-white, water washable
cream for intravaginal administration containing 0.4% of the antifungal agent
terconaz... | custom-source | 2025-02-12T13:45:28.983577 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19579slr026,19641slr022,19964slr021_terazol_lbl.pdf', 'application_number': 19579, 'submission_type': 'SUPPL ', 'submission_number': 26} |
11,542 | NDA 19-583/S-023
Page 3
RL:L15
PRESCRIBING INFORMATION
RELAFEN®
(nabumetone)
Tablets
DESCRIPTION
RELAFEN (nabumetone) is a naphthylalkanone designated chemically as 4-(6-methoxy-2-
naphthalenyl)-2-butanone. It has the following structure:
Nabumetone is a white to off-white crystalline substance with ... | custom-source | 2025-02-12T13:45:29.256406 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019583s023lbl.pdf', 'application_number': 19583, 'submission_type': 'SUPPL ', 'submission_number': 23} |
11,543 | HLR 07/10/02
C:\Data\My Documents\Lariam\Oct02approvedlabel.doc
1
LARIAM
brand of
mefloquine hydrochloride
TABLETS
DESCRIPTION
Lariam (mefloquine hydrochloride) is an antimalarial agent available as 250-mg tablets of
mefloquine hydrochloride (equivalent to 228.0 mg of the free base) for oral administration.
Mefloqu... | custom-source | 2025-02-12T13:45:29.294942 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19591s20lbl.pdf', 'application_number': 19591, 'submission_type': 'ORIG ', 'submission_number': 1} |
11,544 | HLR 07/10/02
C:\Data\My Documents\Lariam\Oct02approvedlabel.doc
1
LARIAM
brand of
mefloquine hydrochloride
TABLETS
DESCRIPTION
Lariam (mefloquine hydrochloride) is an antimalarial agent available as 250-mg tablets of
mefloquine hydrochloride (equivalent to 228.0 mg of the free base) for oral administration.
Mefloqu... | custom-source | 2025-02-12T13:45:29.358753 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19591s20lbl.pdf', 'application_number': 19591, 'submission_type': 'SUPPL ', 'submission_number': 20} |
11,545 | HLR 15aug2003
1
Rx only
LARIAM
brand of
mefloquine hydrochloride
TABLETS
DESCRIPTION
Lariam (mefloquine hydrochloride) is an antimalarial agent available as 250-mg tablets
of mefloquine hydrochloride (equivalent to 228.0 mg of the free base) for oral
administration.
Mefloquine hydrochloride is a 4-quinolinemethanol de... | custom-source | 2025-02-12T13:45:29.421758 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19591slr022_lariam_lbl.pdf', 'application_number': 19591, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,548 | Company logo
LARIAM®
brand of
mefloquine hydrochloride
TABLETS
Rx only
DESCRIPTION
Lariam (mefloquine hydrochloride) is an antimalarial agent available as 250-
mg tablets of mefloquine hydrochloride (equivalent to 228.0 mg of the free
base) for oral administration.
Mefloquine hydrochloride is a 4-quinolineme... | custom-source | 2025-02-12T13:45:29.694071 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591slr027_lbl.pdf', 'application_number': 19591, 'submission_type': 'SUPPL ', 'submission_number': 27} |
11,546 |
1 Roche Logo
2
LARIAM®
3
brand of
4
mefloquine hydrochloride
5
TABLETS
6
Rx only
7
DESCRIPTION
8
Lariam (mefloquine hydrochloride) is an antimalarial agent available as 250
9
mg tablets of mefloquine hydrochloride (equivalent to 228.0 mg of the free
10
base) for oral administration.
11... | custom-source | 2025-02-12T13:45:29.844176 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s023lbl.pdf', 'application_number': 19591, 'submission_type': 'SUPPL ', 'submission_number': 23} |
11,547 |
NDA 19-591/S-026
NDA 19-591/S-028
Page 9 Roche Logo
LARIAM®
brand of
mefloquine hydrochloride
TABLETS
RX ONLY
DESCRIPTION
Lariam (mefloquine hydrochloride) is an antimalarial agent available as 250-mg tablets of mefloquine
hydrochloride (equivalent to 228.0 mg of the free ba... | custom-source | 2025-02-12T13:45:29.877359 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf', 'application_number': 19591, 'submission_type': 'SUPPL ', 'submission_number': 26} |
11,549 |
NDA 19-591/S-026
NDA 19-591/S-028
Page 9 Roche Logo
LARIAM®
brand of
mefloquine hydrochloride
TABLETS
RX ONLY
DESCRIPTION
Lariam (mefloquine hydrochloride) is an antimalarial agent available as 250-mg tablets of mefloquine
hydrochloride (equivalent to 228.0 mg of the free ba... | custom-source | 2025-02-12T13:45:29.959237 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf', 'application_number': 19591, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,550 | 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 | 2025-02-12T13:45:30.225574 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/019593s028lbl.pdf', 'application_number': 19593, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,552 |
PRESCRIBING INFORMATION
ZANTAC®
(ranitidine hydrochloride)
Injection
ZANTAC®
(ranitidine hydrochloride)
Injection Premixed
DESCRIPTION
The active ingredient in ZANTAC Injection and ZANTAC Injection Premixed is ranitidine
hydrochloride (HCl), a histamine H2-receptor antagonis... | custom-source | 2025-02-12T13:45:30.279488 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s053,019593s042lbl.pdf', 'application_number': 19593, 'submission_type': 'SUPPL ', 'submission_number': 42} |
11,551 |
PRESCRIBING INFORMATION
ZANTAC®
(ranitidine hydrochloride)
Injection
ZANTAC®
(ranitidine hydrochloride)
Injection Premixed
DESCRIPTION
The active ingredient in ZANTAC Injection and ZANTAC Injection Premixed is ranitidine
hydrochloride (HCl), a histamine H2-receptor antag... | custom-source | 2025-02-12T13:45:30.334805 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s051,019593s039lbl.pdf', 'application_number': 19593, 'submission_type': 'SUPPL ', 'submission_number': 39} |
11,555 |
MAGNEVIST®
(brand of gadopentetate dimeglumine)
Injection
FOR INTRAVENOUS ADMINISTRATION
Rx only
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with
impaired elimination of the drugs. Avoid use of GB... | custom-source | 2025-02-12T13:45:30.613144 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019596s049lbl.pdf', 'application_number': 19596, 'submission_type': 'SUPPL ', 'submission_number': 49} |
11,553 | NDA 19-596/S-033
Page 3
Rx only
DESCRIPTION
MAGNEVIST® (BRAND OF GADOPENTETATE DIMEGLUMINE) INJECTION IS THE N- METHYLGLUCAMINE
SALT OF THE GADOLINIUM COMPLEX OF DIETHYLENETRIAMINE PENTAACETIC ACID, AND IS AN
INJECTABLE CONTRAST MEDIUM FOR MAGNETIC RESONANCE IMAGING (MRI). MAGNEVIST® INJECTION
IS PR... | custom-source | 2025-02-12T13:45:30.787976 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19596s033lbl.pdf', 'application_number': 19596, 'submission_type': 'SUPPL ', 'submission_number': 33} |
11,554 |
NDA 19-596-S-045/21-037/S-019
Page 3
MAGNEVIST ®
(brand of gadopentetate dimeglumine)
Injection
6703001
FOR INTRAVENOUS ADMINISTRATION
Rx only
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents incre... | custom-source | 2025-02-12T13:45:30.810318 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019596s045,021037s019lbl.pdf', 'application_number': 19596, 'submission_type': 'SUPPL ', 'submission_number': 45} |
11,557 |
_______________________________________________________________________________________________________________________________________
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information nee... | custom-source | 2025-02-12T13:45:30.953467 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019599s011lbl.pdf', 'application_number': 19599, 'submission_type': 'SUPPL ', 'submission_number': 11} |
11,556 |
MAGNEVIST®
(brand of gadopentetate dimeglumine)
Injection
FOR INTRAVENOUS ADMINISTRATION
Rx only
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast agents (GBCAs) increase the... | custom-source | 2025-02-12T13:45:31.071086 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019596s056,021037s029lbl.pdf', 'application_number': 19596, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,559 | NDA 19-600/S-006 & S-009
Page 3
OXSORALEN-ULTRA
CAPSULES
(Methoxsalen Capsules, USP, 10 mg)
Rx ONLY
CAUTION: METHOXSALEN IS A POTENT DRUG. READ ENTIRE BROCHURE PRIOR TO PRESCRIBING
OR DISPENSING THIS MEDICATION.
Methoxsalen with UV radiation should be used only by physicians who have special c... | custom-source | 2025-02-12T13:45:31.175881 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19600slr006,009_oxsoralen-ultra_lbl.pdf', 'application_number': 19600, 'submission_type': 'SUPPL ', 'submission_number': 6} |
11,560 | NDA 19-600/S-006 & S-009
Page 3
OXSORALEN-ULTRA
CAPSULES
(Methoxsalen Capsules, USP, 10 mg)
Rx ONLY
CAUTION: METHOXSALEN IS A POTENT DRUG. READ ENTIRE BROCHURE PRIOR TO PRESCRIBING
OR DISPENSING THIS MEDICATION.
Methoxsalen with UV radiation should be used only by physicians who have special c... | custom-source | 2025-02-12T13:45:31.334672 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19600slr006,009_oxsoralen-ultra_lbl.pdf', 'application_number': 19600, 'submission_type': 'SUPPL ', 'submission_number': 9} |
11,558 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:45:31.369092 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019599s012lbledt.pdf', 'application_number': 19599, 'submission_type': 'SUPPL ', 'submission_number': 12} |
11,561 |
... | custom-source | 2025-02-12T13:45:31.463831 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019614s049lbl.pdf', 'application_number': 19614, 'submission_type': 'SUPPL ', 'submission_number': 49} |
11,562 |
Verelan® capsules
(verapamil hydrochloride)
Sustained-release pellet filled capsules
Rx only
Rev. 06/14
DESCRIPTION
Verelan® (verapamil hydrochloride capsules) is a... | custom-source | 2025-02-12T13:45:31.642767 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019614s050lbl.pdf', 'application_number': 19614, 'submission_type': 'SUPPL ', 'submission_number': 50} |
11,564 |
Prepidil® Gel
dinoprostone cervical gel
For Endocervical Use
DESCRIPTION
PREPIDIL Gel contains dinoprostone as the naturally occurring form of prostaglandin E2
(PGE2) and is designated chemically as (5Z, 11a, 13E, 15S)-11,15-Dihydroxy-9-oxo
prosta-5,13-dien-1-oic acid. The molecular formula is C20H32O5 ... | custom-source | 2025-02-12T13:45:31.707581 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019617s010lbl.pdf', 'application_number': 19617, 'submission_type': 'SUPPL ', 'submission_number': 10} |
11,563 |
07-19-66-240
Baxter
DOPamine Hydrochloride and 5% Dextrose Injection,
USP
in Plastic Container
VIAFLEX Plus Container
DESCRIPTION
Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic
solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection.... | custom-source | 2025-02-12T13:45:31.844623 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019615s021lbl.pdf', 'application_number': 19615, 'submission_type': 'SUPPL ', 'submission_number': 21} |
11,566 | 1
ELOCON®
brand of mometasone furoate cream
Cream 0.1%
For Dermatologic Use Only
Not for Ophthalmic Use
DESCRIPTION ELOCON® (mometasone furoate cream) Cream, 0.1%, contains mometasone
furoate, USP for dermatologic use. Mometasone furoate is a synthetic corticosteroid with anti-
inflammatory activity.
Chemically, momet... | custom-source | 2025-02-12T13:45:31.893598 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19625s12s13lbl.pdf', 'application_number': 19625, 'submission_type': 'SUPPL ', 'submission_number': 12} |
11,567 | 1
ELOCON®
brand of mometasone furoate cream
Cream 0.1%
For Dermatologic Use Only
Not for Ophthalmic Use
DESCRIPTION ELOCON® (mometasone furoate cream) Cream, 0.1%, contains mometasone
furoate, USP for dermatologic use. Mometasone furoate is a synthetic corticosteroid with anti-
inflammatory activity.
Chemically, momet... | custom-source | 2025-02-12T13:45:31.901465 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19625s12s13lbl.pdf', 'application_number': 19625, 'submission_type': 'SUPPL ', 'submission_number': 13} |
11,565 | 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 | 2025-02-12T13:45:31.910529 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019618s018lbl.pdf', 'application_number': 19618, 'submission_type': 'SUPPL ', 'submission_number': 18} |
11,571 | LOT
EXP
M027818/01
62934E
Twenty 50 mL vials
For Single Patient Use Only
FOR INTRAVENOUS ADMINISTRATION
Twenty 50 mL vials
For Single Patient Use Only
FOR INTRAVENOUS ADMINISTRATION
Twenty 50 mL vials
For Single Patient Use Only
FOR INTRAVENOUS ADMINISTRATION
Twenty 50 mL vials
For Single Patient Use Only
FOR INTRAV... | custom-source | 2025-02-12T13:45:32.515194 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019627s60lbl.pdf', 'application_number': 19627, 'submission_type': 'SUPPL ', 'submission_number': 60} |
11,568 | 1
PROFESSIONAL INFORMATION BROCHURE
DIPRIVAN® (propofol) Injectable Emulsion
FOR IV ADMINISTRATION
DESCRIPTION
DIPRIVAN® (propofol) Injectable Emulsion is a sterile, nonpyrogenic emulsion containing 10 mg/mL of
propofol suitable for intravenous administration. Propofol is chemically described as 2,6-diisopropylphenol... | custom-source | 2025-02-12T13:45:32.631935 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19627S35LBL.pdf', 'application_number': 19627, 'submission_type': 'SUPPL ', 'submission_number': 35} |
11,569 | NDA 19-627/S-045
Page 3
Rev
SIC 64180-03
DIPRIVAN®
(propofol) Injectable Emulsion
FOR IV ADMINISTRATION
Strict aseptic technique must always be maintained during handling. Diprivan Injectable
Emulsion is a single-use parenteral product which contains 0.005% disodium edetate to retard
the rate of growth... | custom-source | 2025-02-12T13:45:32.766458 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019627s045lbl.pdf', 'application_number': 19627, 'submission_type': 'SUPPL ', 'submission_number': 45} |
11,570 |
... | custom-source | 2025-02-12T13:45:33.383364 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019627s046lbl.pdf', 'application_number': 19627, 'submission_type': 'SUPPL ', 'submission_number': 46} |
11,574 | ----------
NDA 19635/S-035
Page 4
SODIUM CHLORIDE- sodium chloride injection, solution
B. Braun Medical Inc.
0.9% Sodium Chloride Injection USP
DESCRIPTION
Each 100 mL of 0.9% Sodium Chloride Injection USP contains:
Sodium Chloride USP 0.9 g; Water for Injection USP qs
pH: 5.6 (4.5-7.0)
Calculated Osmola... | custom-source | 2025-02-12T13:45:33.385633 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019635s035lbl.pdf', 'application_number': 19635, 'submission_type': 'SUPPL ', 'submission_number': 35} |
11,573 | NDA 19-634/S-021
Page 3
5% Dextrose in Lactated Ringer’s Injection
DESCRIPTION
Rx only
Each 100 mL of 5% Dextrose in Lactated Ringer’s Injection contains:
Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.6 g
Sodium Lactate 0.31 g; Potassium Chloride USP 0.03 g
Calcium Chloride Dihydrate USP 0.02... | custom-source | 2025-02-12T13:45:33.387650 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19634s021lbl.pdf', 'application_number': 19634, 'submission_type': 'SUPPL ', 'submission_number': 21} |
11,572 | NDA 19-630/S-023
Page 3
Potassium Chloride in Dextrose and Sodium Chloride Injections USP
DESCRIPTION
Rx only
(See chart below for quantitative information.)
Potassium Chloride in Dextrose and Sodium Chloride Injections USP are sterile, nonpyrogenic and
contain no bacteriostatic or antimicrobial a... | custom-source | 2025-02-12T13:45:33.400797 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19630s023lbl.pdf', 'application_number': 19630, 'submission_type': 'SUPPL ', 'submission_number': 23} |
11,576 | S-045 10.12.2005
1
IDENTIFIER
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
HUMATROPE®
SOMATROPIN (rDNA ORIGIN) FOR INJECTION
VIALS
and
CARTRIDGES FOR USE WITH THE
HumatroPen™ INJ... | custom-source | 2025-02-12T13:45:34.216467 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019640s045lbl.pdf', 'application_number': 19640, 'submission_type': 'SUPPL ', 'submission_number': 45} |
11,575 |
1
PA 1643 AMP
1
HUMATROPE®
2
SOMATROPIN (rDNA ORIGIN) FOR INJECTION
3
VIALS
4
and
5
CARTRIDGES FOR USE WITH THE
6
HumatroPen™ INJECTION DEVICE
7
DESCRIPTION
8
Humatrope® (Somatropin, rDNA Origin, for Injection) is a polypeptide hormone of
9
recombinant DNA origin. Humatrope has 191 amino acid resid... | custom-source | 2025-02-12T13:45:34.310253 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19640s040lbl.pdf', 'application_number': 19640, 'submission_type': 'SUPPL ', 'submission_number': 40} |
11,578 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to us... | custom-source | 2025-02-12T13:45:34.494792 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019640s068lbl.pdf', 'application_number': 19640, 'submission_type': 'SUPPL ', 'submission_number': 68} |
11,577 |
1
PA 1646 AMP
HUMATROPE®
SOMATROPIN (rDNA ORIGIN) FOR INJECTION
VIALS and CARTRIDGES
DESCRIPTION
Humatrope® (Somatropin, rDNA Origin, for Injection) is a polypeptide hormone of
recombinant DNA origin. Humatrope has 191 amino acid residues and a molecular weight of
about 22,125 daltons. The amino acid sequence o... | custom-source | 2025-02-12T13:45:34.582734 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf', 'application_number': 19640, 'submission_type': 'SUPPL ', 'submission_number': 52} |
11,582 | TERAZOL
7(terconazole) Vaginal Cream 0.4%
TERAZOL
3(terconazole) Vaginal Cream 0.8%
TERAZOL® 3 (terconazole) Vaginal Suppositories 80 mg
DESCRIPTION
TERAZOL® 7(terconazole) Vaginal Cream 0.4% is a white to off-white, water washable
cream for intravaginal administration containing 0.4% of the antifungal agent
terc... | custom-source | 2025-02-12T13:45:34.834477 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf', 'application_number': 19641, 'submission_type': 'SUPPL ', 'submission_number': 16} |
11,583 | TERAZOL 7(terconazole) Vaginal Cream 0.4%
TERAZOL 3(terconazole) Vaginal Cream 0.8%
TERAZOL® 3 (terconazole) Vaginal Suppositories 80 mg
DESCRIPTION
TERAZOL® 7(terconazole) Vaginal Cream 0.4% is a white to off-white, water washable
cream for intravaginal administration containing 0.4% of the antifungal agent
terconaz... | custom-source | 2025-02-12T13:45:34.866950 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19579slr026,19641slr022,19964slr021_terazol_lbl.pdf', 'application_number': 19641, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,579 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
HUMATROPE safely and effectively. See full prescribing information for
HUMATROPE.
HUMATROPE® [somatropin (rDNA ORIGIN)] for injection, for
Subcutaneous Use
Initial U.S. Approval: 1987
---------------------... | custom-source | 2025-02-12T13:45:35.256719 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019640s078_2lbl.pdf', 'application_number': 19640, 'submission_type': 'SUPPL ', 'submission_number': 78} |
11,581 |
1
[H
Block
graphic]
PV 6501 AMP
Humatrope®
somatropin (rDNA origin)
for injection
HumatroPen® 6 mg
Growth Hormone Delivery
System
Injection Device for Use
with Humatrope®
[somatropin (rDNA origin)
for injection] ... | custom-source | 2025-02-12T13:45:35.274905 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019640s086lbl.pdf', 'application_number': 19640, 'submission_type': 'SUPPL ', 'submission_number': 86} |
11,584 |
NDA 019579/S-035
NDA 019641/S-028
NDA 019964/S-030
Page 4
TERAZOL® 7 VAGINAL CREAM 0.4%
(terconazole)
TERAZOL® 3 VAGINAL CREAM 0.8%
(terconazole)
TERAZOL® 3 VAGINAL SUPPOSITORIES 80mg
(terconazole)
DESCRIPTION
TERAZOL® 7 (terconazole) Vaginal Cream 0.4% is a white to off-white, water washable cream
for ... | custom-source | 2025-02-12T13:45:35.445659 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019579s035,019641s028,019964s030lbl.pdf', 'application_number': 19641, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,586 | TABLETS
MEVACOR®
(LOVASTATIN)
DESCRIPTION
MEVACOR* (Lovastatin) is a cholesterol lowering agent isolated from a strain of Aspergillus terreus.
After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-
hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydr... | custom-source | 2025-02-12T13:45:35.820564 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19643s64lbl.pdf', 'application_number': 19643, 'submission_type': 'SUPPL ', 'submission_number': 64} |
11,587 |
78253XX
TABLETS
MEVACOR®
(LOVASTATIN)
DESCRIPTION
MEVACOR* (Lovastatin) is a cholesterol lowering agent isolated from a strain of Aspergillus terreus.
After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-
hydroxyacid form. This is a principal metabolite and an... | custom-source | 2025-02-12T13:45:35.972564 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19643s075lbl.pdf', 'application_number': 19643, 'submission_type': 'SUPPL ', 'submission_number': 75} |
11,585 |
7825356
TABLETS
MEVACOR®
(LOVASTATIN)
DESCRIPTION
MEVACOR* (Lovastatin) is a cholesterol lowering agent isolated from a strain of Aspergillus terreus.
After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-
hydroxyacid form. This is a principal metabolite and an... | custom-source | 2025-02-12T13:45:36.006467 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019643s061lbl.pdf', 'application_number': 19643, 'submission_type': 'SUPPL ', 'submission_number': 61} |
11,588 |
782535378253XX
TABLETS
MEVACOR®
(LOVASTATIN)
DESCRIPTION
MEVACOR* (Lovastatin) is a cholesterol lowering agent isolated from a strain of Aspergillus terreus.
After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-
hydroxyacid form. This is a principal metabolite... | custom-source | 2025-02-12T13:45:36.077470 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019643s076lbl.pdf', 'application_number': 19643, 'submission_type': 'SUPPL ', 'submission_number': 76} |
11,589 |
company logo
9844661
014-874-01
TABLETS
MEVACOR®
(LOVASTATIN)
DESCRIPTION
MEVACOR* (Lovastatin) is a cholesterol lowering agent isolated from a strain of Aspergillus terreus.
After oral ingestion, lovastatin, which is an in... | custom-source | 2025-02-12T13:45:36.549180 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019643s084lbl.pdf', 'application_number': 19643, 'submission_type': 'SUPPL ', 'submission_number': 84} |
11,591 |
TABLETS
MEVACOR®
(LOVASTATIN)
DESCRIPTION
MEVACOR® (Lovastatin) is a cholesterol lowering agent isolated from a strain of Aspergillus terreus.
After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β
hydroxyacid form. This is a principal metabolite and an in... | custom-source | 2025-02-12T13:45:36.635525 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s086087lbl.pdf', 'application_number': 19643, 'submission_type': 'SUPPL ', 'submission_number': 87} |
11,590 |
Merck logo
9844662
TABLETS
MEVACOR®
(LOVASTATIN)
DESCRIPTION
MEVACOR* (Lovastatin) is a cholesterol lowering agent isolated from a strain of Aspergillus terreus.
After oral ingestion, lovastatin, which is an inactive lactone, is hydro... | custom-source | 2025-02-12T13:45:36.807151 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085lbl.pdf', 'application_number': 19643, 'submission_type': 'SUPPL ', 'submission_number': 85} |
11,592 |
1
TORADOL® ORAL
2
3
4
(ketorolac tromethamine tablets)
Rx only
WARNING
5
TORADOLORAL (ketorolac tromethamine), a nonsteroidal anti-inflammatory drug
6
(NSAID), is indicated for the short-term (up to 5 days in adults), management of
7
moderately severe acute pain that requires analgesia at the opioid level... | custom-source | 2025-02-12T13:45:36.854218 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019645s017lbl.pdf', 'application_number': 19645, 'submission_type': 'SUPPL ', 'submission_number': 17} |
11,593 | 1
TORADOL ORAL
(ketorolac tromethamine tablets)
Rx only
WARNING
TORADOLORAL (ketorolac tromethamine), a nonsteroidal anti-inflammatory drug
(NSAID), is indicated for the short-term (up to 5 days in adults), management of
moderately severe acute pain that requires analgesia at the opioid level and only as
con... | custom-source | 2025-02-12T13:45:36.974888 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019645s019lbl.pdf', 'application_number': 19645, 'submission_type': 'SUPPL ', 'submission_number': 19} |
11,594 | Flumadine® Tablets
(rimantadine hydrochloride tablets)
Flumadine® Syrup
(rimantadine hydrochloride syrup)
DESCRIPTION: Flumadine¨ (rimantadine hydrochloride) is a synthetic antiviral drug available as a
100 mg film-coated tablet and as a syrup for oral administration. Each film-coated tablet contains
100 mg of rimantad... | custom-source | 2025-02-12T13:45:37.045869 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19650S4lbl.pdf', 'application_number': 19649, 'submission_type': 'SUPPL ', 'submission_number': 6} |
11,596 | Flumadine® Tablets
(rimantadine hydrochloride tablets)
Flumadine® Syrup
(rimantadine hydrochloride syrup)
DESCRIPTION: Flumadine¨ (rimantadine hydrochloride) is a synthetic antiviral drug available as a
100 mg film-coated tablet and as a syrup for oral administration. Each film-coated tablet contains
100 mg of rimantad... | custom-source | 2025-02-12T13:45:37.104924 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19650S4lbl.pdf', 'application_number': 19650, 'submission_type': 'ORIG ', 'submission_number': 1} |
11,595 | 040510.Final Draft PI clean
Flumadine® Tablets
(rimantadine hydrochloride tablets)
Rx only
DESCRIPTION: Flumadine® (rimantadine hydrochloride) is a synthetic antiviral drug available as a
100 mg film-coated tablet. Each film-coated tablet contains 100 mg of rimantadine hydrochloride plus
hypromellose, magne... | custom-source | 2025-02-12T13:45:37.278621 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019649s015lbl.pdf', 'application_number': 19649, 'submission_type': 'SUPPL ', 'submission_number': 15} |
11,597 |
Flumadine® Tablets
(rimantadine hydrochloride tablets)
Flumadine® Syrup
(rimantadine hydrochloride syrup)
Rx only
DESCRIPTION: Flumadine® (rimantadine hydrochloride) is a synthetic antiviral drug
available as a 100 mg film-coated tablet and as a syrup for oral administration. Each film-
coated tablet cont... | custom-source | 2025-02-12T13:45:37.344925 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019649s010,019650s007lbl.pdf', 'application_number': 19650, 'submission_type': 'SUPPL ', 'submission_number': 7} |
11,598 |
Asacol®
(mesalamine)
Delayed-Release Tablets
DESCRIPTION: Each Asacol delayed-release tablet for oral administration contains 400 mg of
mesalamine, an anti-inflammatory drug. The Asacol delayed-release tablets are coated with
acrylic based resin, Eudragit S (methacrylic acid copolymer B, NF),... | custom-source | 2025-02-12T13:45:37.358810 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019651s023lbl.pdf', 'application_number': 19651, 'submission_type': 'SUPPL ', 'submission_number': 23} |
11,599 |
... | custom-source | 2025-02-12T13:45:37.689661 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019651s024lbl.pdf', 'application_number': 19651, 'submission_type': 'SUPPL ', 'submission_number': 24} |
11,600 |
... | custom-source | 2025-02-12T13:45:37.830400 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019651s025lbl.pdf', 'application_number': 19651, 'submission_type': 'SUPPL ', 'submission_number': 25} |
11,601 | NDA 19-653/S-037
NDA 19-697/S-034
Package Insert
Page 1
PHYSICIANS' PACKAGE INSERT
ORTHO TRI-CYCLEN® TABLETS
ORTHO-CYCLEN® TABLETS
(norgestimate/ethinyl estradiol)
Patients should be counseled that this product does not protect against HIV infection (AIDS) and
other sexually transmitted diseases.
DESC... | custom-source | 2025-02-12T13:45:37.991853 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019653s037,019697s034lbl.pdf', 'application_number': 19653, 'submission_type': 'SUPPL ', 'submission_number': 37} |
11,602 |
ORTHO TRI-CYCLEN TABLETS (norgestimate/ethinyl estradiol)
and ORTHO-CYCLEN TABLETS (norgestimate/ethinyl estradiol)
WARNINGS: CARDIOVASCULAR RISK ASSOCIATED WITH
SMOKING
Cigarette smoking increases the risk of serious cardiovascular events from
combination oral contraceptive use. This risk increases wi... | custom-source | 2025-02-12T13:45:38.106133 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019653Orig1s046,019697Orig1s042lbl.pdf', 'application_number': 19653, 'submission_type': 'SUPPL ', 'submission_number': 46} |
11,603 |
10305001
barcode
barcode
ORTHO TRI-CYCLEN® TABLETS
ORTHO-CYCLEN® TABLETS
(norgestimate/ethinyl estradiol)
Patients should be counseled that this product does
not protect against HIV infection (AIDS) and other
sexually transmitted diseases.
barcode
DESCRIPTION
Each of the following products is ... | custom-source | 2025-02-12T13:45:38.447760 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019653s048lbl.pdf', 'application_number': 19653, 'submission_type': 'SUPPL ', 'submission_number': 48} |
11,605 | RETROVIR® (zidovudine) Tablets, Capsules, and Syrup
1
PRODUCT INFORMATION
1
RETROVIR® (zidovudine) Tablets
2
RETROVIR® (zidovudine) Capsules
3
RETROVIR® (zidovudine) Syrup
4
5
WARNING: RETROVIR (ZIDOVUDINE) MAY BE ASSOCIATED WITH
6
HEMATOLOGIC TOXICITY INCLUDING GRANULOCYTOPENIA AND SEVERE
7
ANEMIA PARTICULARLY IN PATI... | custom-source | 2025-02-12T13:45:38.638931 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19655s36lbl.pdf', 'application_number': 19655, 'submission_type': 'SUPPL ', 'submission_number': 36} |
11,604 |
... | custom-source | 2025-02-12T13:45:38.802410 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019653s056,019697s052,021690s001lbl.pdf', 'application_number': 19653, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,607 |
... | custom-source | 2025-02-12T13:45:38.989925 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033,019655s046,020518s016lbl.pdf', 'application_number': 19655, 'submission_type': 'SUPPL ', 'submission_number': 46} |
11,609 |
... | custom-source | 2025-02-12T13:45:39.215725 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019655s052,019910s039,020518s022lbl.pdf', 'application_number': 19655, 'submission_type': 'SUPPL ', 'submission_number': 52} |
11,606 | NDA 19-655/S-041
NDA 19-910/S-029
NDA 20-518/S-013
Page 3
PRESCRIBING INFORMATION
RETROVIR®
FINAL AGREED-UPON PI 05/08/2006
(zidovudine)
Tablets
RETROVIR®
(zidovudine)
Capsules
RETROVIR®
(zidovudine)
Syrup
WARNING
RETROVIR (ZIDOVUDINE) HAS BEEN ASSOCIATED WITH HEMATOLOGIC
TOXICITY INCLUDI... | custom-source | 2025-02-12T13:45:39.326229 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s41,019910s29,020518s13lbl.pdf', 'application_number': 19655, 'submission_type': 'SUPPL ', 'submission_number': 41} |
11,608 |
... | custom-source | 2025-02-12T13:45:39.560349 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019655s049lbl.pdf', 'application_number': 19655, 'submission_type': 'SUPPL ', 'submission_number': 49} |
11,612 |
Sandostatin®
octreotide acetate
Injection
Rx Only
T2002-XX
XXXXXXXX
as a clear sterile
inistration by deep
or intravenous injection. Octreotide acetate, known chemically as
-lysyl-L-
-(R*, R*)]
acetate salt, is a long-acting octapeptide with pharmacologic actions ... | custom-source | 2025-02-12T13:45:39.651664 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19667scm044_Sandostatin_lbl.pdf', 'application_number': 19667, 'submission_type': 'SUPPL ', 'submission_number': 44} |
11,613 |
----------
Sandostatin®
Page 1 of 15
SANDOSTATIN - octreotide injection, solution
Novartis Pharmaceuticals Corporation
Sandostatin®
Rx Only
Prescribing Information
DESCRIPTION
Sandostatin® (octreotide acetate) Injection, a cyclic octapeptide pre... | custom-source | 2025-02-12T13:45:39.943584 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019667s054lbl.pdf', 'application_number': 19667, 'submission_type': 'SUPPL ', 'submission_number': 54} |
11,611 | 1
1
CYTOVENE-IV
2
(ganciclovir sodium for injection)
3
FOR INTRAVENOUS INFUSION ONLY
4
5
Rx only
6
WARNING
7
THE
CLINICAL
TOXICITY
OF
CYTOVENE-IV
INCLUDES
8
GRANULOCYTOPENIA, ANEMIA AND THROMBOCYTOPENIA. IN ANIMAL
9
STUDIES GANCICLOVIR WAS CARCINOGENIC, TERATOGENIC AND
10
CAUSED ASPERMATOGE... | custom-source | 2025-02-12T13:45:40.056537 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf', 'application_number': 19661, 'submission_type': 'SUPPL ', 'submission_number': 30} |
11,614 | octreotide acetate
INJECTION
Rx only
50 mcg/mL
octreotide acetate INJECTION
50 mcg/mL; Each mL contains:
octreotide (as acetate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 mcg
Inactive ingredients
lactic acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... | custom-source | 2025-02-12T13:45:40.334414 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019667Orig1s062lbl.pdf', 'application_number': 19667, 'submission_type': 'SUPPL ', 'submission_number': 62} |
11,615 |
PATIENT INFORMATION ABOUT CARDURA®
Generic Name:
doxazosin mesylate
FOR BENIGN PROSTATIC HYPERPLASIA (BPH)
Read this leaflet:
• before you start taking CARDURA®
• each time you get a new prescription.
You and your doctor should discuss this treatment and your BPH sym... | custom-source | 2025-02-12T13:45:40.352286 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019668s022lbl.pdf', 'application_number': 19668, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,610 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:45:40.438700 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019658Orig1s044lbl.pdf', 'application_number': 19658, 'submission_type': 'SUPPL ', 'submission_number': 44} |
11,617 |
_______________________________________________... | custom-source | 2025-02-12T13:45:40.788627 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019668s028lbl.pdf', 'application_number': 19668, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,618 | © 2002 Distributed by Schering-Plough HealthCare Products, Inc.
Memphis, TN 38151 USA. All rights reserved. XXXXX-XX
10 EXTENDED RELEASE TABLETS
0
8
41100 80208
The graphics on the front panel of this carton constitute
trademarks of Schering Corporation.
00000000
00000000
Pseudoephedrine Sulfate 120 mg/Nasal Decong... | custom-source | 2025-02-12T13:45:40.846219 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19670s019,20470s022lbl.pdf', 'application_number': 19670, 'submission_type': 'SUPPL ', 'submission_number': 19} |
11,616 |
... | custom-source | 2025-02-12T13:45:40.946894 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019668s026lbl.pdf', 'application_number': 19668, 'submission_type': 'SUPPL ', 'submission_number': 26} |
11,621 |
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 | 2025-02-12T13:45:41.101934 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s067,019675s034,020251s018lbl.pdf', 'application_number': 19675, 'submission_type': 'SUPPL ', 'submission_number': 34} |
11,622 |
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 | 2025-02-12T13:45:41.221074 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf', 'application_number': 19675, 'submission_type': 'SUPPL ', 'submission_number': 35} |
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