id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
10,683 | 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 | 2025-02-12T13:43:35.455617 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/6188s018s019Lbl.pdf', 'application_number': 6188, 'submission_type': 'SUPPL ', 'submission_number': 19} |
10,682 |
... | custom-source | 2025-02-12T13:43:35.494187 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/006134s038lbl.pdf', 'application_number': 6134, 'submission_type': 'SUPPL ', 'submission_number': 38} |
10,684 |
PROPYLTHIOURACIL TABLETS, USP
PROPYLTHIOURACIL TABLETS, USP
DESCRIPTION
WARNING: Severe liver injury and acute liver failure, in some cases fatal,
have been reported in patients treated with propylthiouracil. These reports of
hepatic reactions include cases requiring liver tran... | custom-source | 2025-02-12T13:43:35.519781 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006188s020lbl.pdf', 'application_number': 6188, 'submission_type': 'SUPPL ', 'submission_number': 20} |
10,685 |
... | custom-source | 2025-02-12T13:43:35.688221 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/006188s021s022lbl.pdf', 'application_number': 6188, 'submission_type': 'SUPPL ', 'submission_number': 22} |
10,687 |
1
721566-04
451175A/Revised February 2010
®
2
Xylocaine (lidocaine HCl Injection, USP)
®
3
Xylocaine (lidocaine HCl and epinephrine Injection, USP)
4
For Infiltration and Nerve Block
5
Rx only
6
DESCRIPTION :
7
Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous ... | custom-source | 2025-02-12T13:43:35.825373 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006488s074lbl.pdf', 'application_number': 6488, 'submission_type': 'SUPPL ', 'submission_number': 74} |
10,688 | NDA 6-927/S-030
NDA 9-112/S-021
Page 3
Rx only
Eurax
(crotamiton USP)
Lotion/Cream
FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIIC, ORAL, OR INTRAVAGINAL USE
DESCRIPTION
Eurax (crotamiton USP) is a scabicidal and antipruritic agent available as a cream or lotion for topica... | custom-source | 2025-02-12T13:43:35.828713 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06927slr030,09112slr021_eurax_lbl.pdf', 'application_number': 6927, 'submission_type': 'SUPPL ', 'submission_number': 30} |
10,686 |
PROPYLTHIOURACIL TABLETS, USP
WARNING: Severe liver injury and acute liver failure, in some cases fatal,
have been reported in patients treated with propylthiouracil. These reports of
hepatic reactions include cases requiring li... | custom-source | 2025-02-12T13:43:35.893692 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/006188s024lbl.pdf', 'application_number': 6188, 'submission_type': 'SUPPL ', 'submission_number': 24} |
10,689 |
Azulfidine®
sulfasalazine tablets, USP
DESCRIPTION
AZULFIDINE Tablets contain sulfasalazine, 500 mg, for oral administration.
Therapeutic Classification: Anti-inflammatory agent.
Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid.
Chemical Structure: ... | custom-source | 2025-02-12T13:43:36.025721 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/007073s128lbl.pdf', 'application_number': 7073, 'submission_type': 'SUPPL ', 'submission_number': 128} |
10,690 | NDA 7-337/S-029
Page 3
PERCODAN®
(Oxycodone and Aspirin Tablets, USP)
CII
Rx only
DESCRIPTION
Each PERCODAN Tablet contains:
Oxycodone Hydrochloride 4.5 mg*
Oxycodone Terephthalate 0.38 mg*
Aspirin, USP 325 mg
*The total of 4.5 mg oxycodone HCl and 0.38... | custom-source | 2025-02-12T13:43:36.254532 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/07337slr029_percodan_lbl.pdf', 'application_number': 7337, 'submission_type': 'SUPPL ', 'submission_number': 29} |
10,692 |
Structural Formula
CII Company logo
PERCODAN®
(Oxycodone and Aspirin Tablets, USP)
Rx only
DESCRIPTION
Each PERCODAN Tablet contains:
Oxycodone Hydrochloride, USP
4.8355 mg*
Aspirin, USP
325 mg
*4.8355 mg oxycodone HCl is equivalent to ... | custom-source | 2025-02-12T13:43:36.333304 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/007337s045lbl.pdf', 'application_number': 7337, 'submission_type': 'SUPPL ', 'submission_number': 45} |
10,691 | 1
PERCODAN®
(Oxycodone and Aspirin Tablets, USP)
CII
Rx only
DESCRIPTION
Each PERCODAN Tablet contains:
Oxycodone Hydrochloride, USP 4.8355 mg*
Aspirin, USP 325 mg
*4.8355 mg oxycodone HCl is equivalent to 4.3346 mg of oxycodone as the free base.
... | custom-source | 2025-02-12T13:43:36.433564 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/007337s043lbl.pdf', 'application_number': 7337, 'submission_type': 'SUPPL ', 'submission_number': 43} |
10,693 |
structural formula
CII company logo
PERCODAN®
(Oxycodone and Aspirin Tablets, USP)
Rx only
DESCRIPTION
Each PERCODAN Tablet contains:
Oxycodone Hydrochloride, USP
4.8355 mg*
Aspirin, USP
325 mg
*4.8355 mg oxycodone HCl is equivalent to ... | custom-source | 2025-02-12T13:43:36.446319 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/007337s046lbl.pdf', 'application_number': 7337, 'submission_type': 'SUPPL ', 'submission_number': 46} |
10,694 | I
PV 0373
UCP
TABLETS
TAPAz()LECI
METHIMAZOLE'.,
. TABLETS, USP
~
I)ESCRIPTION
rapazole~(Mathlmazole Tablets, USP)
(1-methylimlrlazole-2-thiol) is a white,
crystallne súbstance that Is freely soluble
in water.
It differs
chemically
from the drugs
oftt:e.thiouracll series primarily because it
has as-Inste... | custom-source | 2025-02-12T13:43:36.583005 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/007517s022lbl.pdf', 'application_number': 7517, 'submission_type': 'SUPPL ', 'submission_number': 22} |
10,696 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
BENOQUIN
® CREAM 20%
(Monobenzone Cream, USP)
Only.
FOR EXTERNAL USE ONLY
DESCRIPTION:
Monobenzone is the monobenzyl ether of hydroquinone.
Monobenzone occurs as a white, almost tasteless c... | custom-source | 2025-02-12T13:43:36.647736 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08173slr015_benoquin_lbl.pdf', 'application_number': 8173, 'submission_type': 'SUPPL ', 'submission_number': 15} |
10,697 | Apresoline hydrochloride(ß
Apresoline(ß hydrochloride
hydralazine hydrochloride USP
Tablets
Prescribing Information
DESCRIPTION
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - _. ~.. - _. - _. - - - - - - - - - - - - - - - - - - - - - - - _. - - - - -. - -. - - - - - - - - - - --
# Strength Form
1 1... | custom-source | 2025-02-12T13:43:36.690966 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1996/008303s068lbl.pdf', 'application_number': 8303, 'submission_type': 'SUPPL ', 'submission_number': 68} |
10,695 |
______________________________________________________________________________________________________________________________________... | custom-source | 2025-02-12T13:43:36.746923 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007961s028lbl.pdf', 'application_number': 7961, 'submission_type': 'SUPPL ', 'submission_number': 28} |
10,700 |
PRIMAQUINE
PHOSPHATE
TABLETS, USP
DESCRIPTION
Primaquine phosphate is 8-[(4-Amino-1-methylbutyl) amino]-6-methoxyquinoline phosphate, a
synthetic compound with potent antim... | custom-source | 2025-02-12T13:43:37.181392 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008316s021lbl.pdf', 'application_number': 8316, 'submission_type': 'SUPPL ', 'submission_number': 21} |
10,699 | NDA 8-316/S-015
Page 3
GERIATRIC MARKED/ANNOTATED - PSW-11D
PRIMAQUINE
PHOSPHATE
TABLETS, USP
WARNING: PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH
THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING PRIMAQUINE
PHOSPHATE.
DESCRIPTION
Primaquine phosphate is 8-[(4-Amino-1-methylbutyl) ... | custom-source | 2025-02-12T13:43:37.229499 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08316slr015_primaquine_lbl.pdf', 'application_number': 8316, 'submission_type': 'SUPPL ', 'submission_number': 15} |
10,698 | .7789 Promethazine HCI and Codeine Phosphate Oral Solution C- V
Page 1 of 13
PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION - promethazine
hydrochloride and codeine phosphate solution
ANI Pharmaceuticals, Inc.
7789
Promethazine HCI and Codeine Phosphate Oral Solution C-V
Rx Only
DESCRIPTION
Each 5 mL (one teaspoo... | custom-source | 2025-02-12T13:43:37.233936 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008306s030lbl.pdf', 'application_number': 8306, 'submission_type': 'SUPPL ', 'submission_number': 30} |
10,701 |
______________________________________________________________________________________________________________________________________... | custom-source | 2025-02-12T13:43:37.433210 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008370s032lbl.pdf', 'application_number': 8370, 'submission_type': 'SUPPL ', 'submission_number': 32} |
10,704 | NDA 08-578/S-016
PRESCRIBING INFORMATION
DARAPRIM®
(pyrimethamine)
25-mg Scored Tablets
DESCRIPTION
DARAPRIM (pyrimethamine) is an antiparasitic compound available in tablet form for oral administration. Each
scored tablet contains 25 mg pyrimethamine and the inactive ingredients corn and potato starch,... | custom-source | 2025-02-12T13:43:37.474069 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08578slr016_daraprim_lbl.pdf', 'application_number': 8578, 'submission_type': 'SUPPL ', 'submission_number': 16} |
10,703 |
Anectine® (Succinylcholine Chloride Injection, USP)
WARNING
RISK OF CARDIAC ARREST FROM HYPERKALEMIC RHABDOMYOLYSIS
There have been rare reports of acute rhabdomyolysis with hyperkalemia followed by
ventricular dysrhythmias, cardiac arrest, and death after the administrati... | custom-source | 2025-02-12T13:43:37.514783 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/008453s027lbl.pdf', 'application_number': 8453, 'submission_type': 'SUPPL ', 'submission_number': 27} |
10,702 |
_________________________________________________________________________________________________________________... | custom-source | 2025-02-12T13:43:37.575925 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007409s042,008370s033lbl.pdf', 'application_number': 8370, 'submission_type': 'SUPPL ', 'submission_number': 33} |
10,705 |
Isoniazid Tablets, USP
Rx only
WARNING
Severe and sometimes fatal hepatitis associated with iso... | custom-source | 2025-02-12T13:43:37.744027 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008678s028lbl.pdf', 'application_number': 8678, 'submission_type': 'SUPPL ', 'submission_number': 28} |
10,706 |
Dilantin-125®
(Phenytoin Oral Suspension, USP)
(NOT FOR PARENTERAL USE)
DESCRIPTION
Dilantin (phenytoin) is related to the barbiturates in chemical structure, but has a five-membered ring. The
chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the followi... | custom-source | 2025-02-12T13:43:37.833467 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s038lbl.pdf', 'application_number': 8762, 'submission_type': 'SUPPL ', 'submission_number': 38} |
10,707 |
NDA 008762 Dilantin-125 (phenytoin) Oral Suspension
FDA Approved Labeling Text dated 10/2011
Page 1 of 16
Dilantin-125®
(Phenytoin Oral Suspension, USP)
(FOR ORAL ADMINISTRATION ONLY; NOT FOR PARENTERAL USE)
DESCRIPTION
Dilantin (phenytoin) is related to the b... | custom-source | 2025-02-12T13:43:37.922948 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf', 'application_number': 8762, 'submission_type': 'SUPPL ', 'submission_number': 39} |
10,709 |
NDA 010151 Dilantin injection S-038
FDA Approved Labeling Text Jan 2014
Parenteral
Dilantin
(Phenytoin Sodium Injection, USP)
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID
... | custom-source | 2025-02-12T13:43:38.157090 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s050,010151s038lbl.pdf', 'application_number': 8762, 'submission_type': 'SUPPL ', 'submission_number': 50} |
10,708 |
NDA 08762 Dilantin-125 (Phenytoin Oral Suspension, USP)
FDA Approved Labeling Text dated 02/2013
Page 1 of 15
Dilantin-125®
(Phenytoin Oral Suspension, USP)
(FOR ORAL ADMINISTRATION ONLY; NOT FOR PARENTERAL USE)
DESCRIPTION
Dilantin (phenytoin) is related ... | custom-source | 2025-02-12T13:43:38.225342 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008762s047lbl.pdf', 'application_number': 8762, 'submission_type': 'SUPPL ', 'submission_number': 47} |
10,711 |
HIGHLIGHTS O... | custom-source | 2025-02-12T13:43:38.277469 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/008809s065lbl.pdf', 'application_number': 8809, 'submission_type': 'SUPPL ', 'submission_number': 65} |
10,710 | NDA 8-809/S-054
Page 4
M.V.I. – 12 ®
(Multi-Vitamin Infusion without vitamin K)
For dilution in intravenous infusions only.
only
M.V.I. - 12® UNIT VIAL
multi-vitamin infusion without vitamin K
DESCRIPTION
M.V.I. - 12® UNIT VIAL is a sterile product in a two-chambered single-dose vial which must be
... | custom-source | 2025-02-12T13:43:38.300778 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08809s054lbl.pdf', 'application_number': 8809, 'submission_type': 'SUPPL ', 'submission_number': 54} |
10,712 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
M.V.I.-12™
M.V.I.-12™ Unit Vial (Multi-Vitamin Infusion without vitamin K) for
dilution in intravenous infusions only.
Unit Vial (Multi-Vitamin Infusion without vitamin K) safely
and effectively. See full pres... | custom-source | 2025-02-12T13:43:38.454005 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008809s066lbl.pdf', 'application_number': 8809, 'submission_type': 'SUPPL ', 'submission_number': 66} |
10,714 | NDA 9-000/S-022/S-023
Package Insert
Page 1
T2001-27
89000402
CAFERGOT®
(ergotamine tartrate and caffeine)
SUPPOSITORIES, USP
Rx only
WARNING
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of
CAFERGOT® with potent CYP 3A4 inhibitors including prote... | custom-source | 2025-02-12T13:43:38.653464 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/9000s22s23lbl.pdf', 'application_number': 9000, 'submission_type': 'SUPPL ', 'submission_number': 22} |
10,713 | NDA 8-816/S-032
Page 3
721838-
XYLOCAINE 2% JELLY
(lidocaine hydrochloride)
DESCRIPTION
Xylocaine (lidocaine HCl) 2% Jelly is a sterile aqueous product that contains a local anesthetic
agent and is administered topically. (See INDICATIONS for specific uses.)
Xylocaine 2% Jelly contains lidocaine HCl whi... | custom-source | 2025-02-12T13:43:38.717933 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08816s032lbl.pdf', 'application_number': 8816, 'submission_type': 'SUPPL ', 'submission_number': 32} |
10,716 |
PURINETHOL® (mercaptopurine) 50-mg Scored Tablets
CAUTION
PURINETHOL (mercaptopurine) is a potent drug. It should not be used unless a diagnosis
of acute lymphatic leukemia has been adequately established and the responsible physician
is experienced with the risks of PURINETHOL and know... | custom-source | 2025-02-12T13:43:38.750858 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009053s032lbl.pdf', 'application_number': 9053, 'submission_type': 'SUPPL ', 'submission_number': 32} |
10,715 | PRESCRIBING INFORMATION
522
INETHOL®
captopurine)
g
Scored
Tablets
HOL (mercaptopurine) is a potent drug. It should not be used unless a diagnosis of
sible physician is
of purinethol and knowledgeable in assessing response to
PURINETHOL (mercaptopurine) was synthesized and developed by Hitchings, Elion, a... | custom-source | 2025-02-12T13:43:38.780223 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09053s024lbl.pdf', 'application_number': 9053, 'submission_type': 'SUPPL ', 'submission_number': 24} |
10,717 | NDA 6-927/S-030
NDA 9-112/S-021
Page 3
Rx only
Eurax
(crotamiton USP)
Lotion/Cream
FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIIC, ORAL, OR INTRAVAGINAL USE
DESCRIPTION
Eurax (crotamiton USP) is a scabicidal and antipruritic agent available as a cream or lotion for topica... | custom-source | 2025-02-12T13:43:38.870256 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06927slr030,09112slr021_eurax_lbl.pdf', 'application_number': 9112, 'submission_type': 'SUPPL ', 'submission_number': 21} |
10,719 |
structural formula
________________________________________________________________
Mysoline®
(primidone, USP)
Anticonvulsant
Rx only
DESCRIPTION
Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione. Structural
formula:
C12H14N2O2
M.W.218.25
Mysoline* (primidone) is a white, cryst... | custom-source | 2025-02-12T13:43:38.962556 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009170s035lbl.pdf', 'application_number': 9170, 'submission_type': 'SUPPL ', 'submission_number': 35} |
10,720 |
... | custom-source | 2025-02-12T13:43:39.063948 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s024lbl.pdf', 'application_number': 9190, 'submission_type': 'SUPPL ', 'submission_number': 24} |
10,718 |
Rx Only
Delatestryl®
(Testosterone Enanthate Injection, USP)
Multiple Dose Vial company logo
DESCRIPTION
DELATESTRYL® (Testosterone Enanthate Injection, USP... | custom-source | 2025-02-12T13:43:39.102570 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009165s032lbl.pdf', 'application_number': 9165, 'submission_type': 'SUPPL ', 'submission_number': 32} |
10,721 | 1
COUMADIN TABLETS
Anticoagulant
(Warfarin Sodium Tablets, USP) Crystalline
COUMADIN FOR INJECTION
(Warfarin Sodium for Injection, USP)
WARNING: BLEEDING RISK
Warfarin sodium can cause major or fatal bleeding. Bleeding is more likely to occur
during the starting period and with a higher dose (r... | custom-source | 2025-02-12T13:43:39.418218 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/009218s102lbl.pdf', 'application_number': 9218, 'submission_type': 'SUPPL ', 'submission_number': 102} |
10,722 |
COUMADIN® TABLETS
(Warfarin Sodium Tablets, USP) Crystalline
COUMADIN® FOR INJECTION
(Warfarin Sodium for Injection, USP)
Anticoagulant
WARNING: BLEEDING RISK
Warfarin sodium can cause major or fatal bleeding. Bleeding is more likely to occur during the
starting period and with a higher dose (resulting... | custom-source | 2025-02-12T13:43:39.419824 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009218s108lbl.pdf', 'application_number': 9218, 'submission_type': 'SUPPL ', 'submission_number': 108} |
10,724 |
NDA 09-321; CHOLOGRAFIN® MEGLUMINE (Iodipamide Meglumine Injection USP 52%)
CHOLOGRAFIN _PI_(Patheon-CL64903) CLEAN_Rev June-2015 company logo
Bracco Diagno... | custom-source | 2025-02-12T13:43:39.526731 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009321s028lbl.pdf', 'application_number': 9321, 'submission_type': 'SUPPL ', 'submission_number': 28} |
10,723 |
... | custom-source | 2025-02-12T13:43:39.676782 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf', 'application_number': 9218, 'submission_type': 'SUPPL ', 'submission_number': 115} |
10,725 |
1
PRESCRIBING INFORMATION
2
LANOXIN®
3
(digoxin)
4
Injection
5
500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per mL)
6
DESCRIPTION
7
LANOXIN (digoxin) is one of the cardiac (or digitalis) glycosides, a closely related group of
8
drugs having in common specific effects on the myocar... | custom-source | 2025-02-12T13:43:40.025880 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009330s026lbl.pdf', 'application_number': 9330, 'submission_type': 'SUPPL ', 'submission_number': 26} |
10,726 |
... | custom-source | 2025-02-12T13:43:40.057750 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/009330s027lbl.pdf', 'application_number': 9330, 'submission_type': 'SUPPL ', 'submission_number': 27} |
10,727 | PRESCRIBING INFORMATION
1
MYLERAN®
2
(busulfan)
3
Tablets
4
5
WARNING
6
MYLERAN is a potent drug. It should not be used unless a diagnosis of chronic myelogenous
7
leukemia has been adequately established and the responsible physician is knowledgeable in
8
assessing response to chemotherapy.
9
MYLERAN can induce severe... | custom-source | 2025-02-12T13:43:40.082656 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/009386s019lbl.pdf', 'application_number': 9386, 'submission_type': 'SUPPL ', 'submission_number': 19} |
10,728 | NDA 09-402/S-037 and 039
Page 3
DELESTROGEN®
(ESTRADIOL VALERATE INJECTION, USP)
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate
diagnostic measures, including endometrial sampling when indicated, should be
undertaken to ... | custom-source | 2025-02-12T13:43:40.159949 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09402slr037_delestrogen_lbl.pdf', 'application_number': 9402, 'submission_type': 'SUPPL ', 'submission_number': 37} |
10,730 |
KEMADRIN
(procyclidine hydrochloride)
5 mg Scored Tablets
Description: KEMADRIN (procyclidine hydrochloride) is a synthetic antispasmodic
compound of relatively low toxicity. It has been shown to be useful for the symptomatic
treatment of parkinsonism (paralysis agitans) and extrapyramidal dysfunction caus... | custom-source | 2025-02-12T13:43:40.302293 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009818s018lbl.pdf', 'application_number': 9818, 'submission_type': 'SUPPL ', 'submission_number': 18} |
10,732 | 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 | 2025-02-12T13:43:40.450359 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/09829s9lbl.pdf', 'application_number': 9830, 'submission_type': 'SUPPL ', 'submission_number': 10} |
10,729 |
1
2
451109C/Revised: February 2010
3
4
Nesacaine® (chloroprocaine HCl Injection, USP)
5
Nesacaine®-MPF (chloroprocaine HCl Injection, USP)
6
For Infiltration and Nerve Block
7
8
DESCRIPTION:
9
Nesacaine and Nesacaine-MPF Injections are sterile non pyrogenic local anesthetics. The
10
... | custom-source | 2025-02-12T13:43:40.559646 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf', 'application_number': 9435, 'submission_type': 'SUPPL ', 'submission_number': 35} |
10,731 | 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 | 2025-02-12T13:43:40.565743 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf', 'application_number': 9829, 'submission_type': 'SUPPL ', 'submission_number': 9} |
10,733 |
Solu-Cortef® (hydrocortisone sodium succinate for injection, USP)
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
For Intravenous or Intramuscular Administration
DESCRIPTION
SOLU-CORTEF Sterile Powder is an anti-inflamma... | custom-source | 2025-02-12T13:43:40.647241 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009866s77s79lbl.pdf', 'application_number': 9866, 'submission_type': 'SUPPL ', 'submission_number': 79} |
10,734 |
SOLU-CORTEF® (hydrocortisone sodium succinate for injection, USP)
For Intravenous or Intramuscular Administration
DESCRIPTION
SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid, which contains
hydrocortisone sodium succinate as the a... | custom-source | 2025-02-12T13:43:40.726438 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009866s080lbl.pdf', 'application_number': 9866, 'submission_type': 'SUPPL ', 'submission_number': 80} |
10,735 |
NDA 10-040; CYSTOGRAFIN ® (Diatrizoate Meglumine Injection USP 30%)
CYSTOGRAFIN_PI_(Patheon-CL64A03) CLEAN_Rev June ... | custom-source | 2025-02-12T13:43:40.852626 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010040s171lbl.pdf', 'application_number': 10040, 'submission_type': 'SUPPL ', 'submission_number': 171} |
10,737 |
NDA 010151
Dilantin (phenytoin sodium) Injection
FDA Approved Labeling Text dated 10/2011
Page 1 of 14
Parenteral
Dilantin®
(Phenytoin Sodium Injection, USP)
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID
INFUSION
The rate of intravenous Dilantin administration should not exce... | custom-source | 2025-02-12T13:43:40.917096 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010151s036lbl.pdf', 'application_number': 10151, 'submission_type': 'SUPPL ', 'submission_number': 36} |
10,736 |
Merck logo
7918719
TABLETS
MEPHYTON®
(PHYTONADIONE)
Vitamin K1
DESCRIPTION
Phytonadione is a vitamin which is a clear, yellow to amber, viscous, and n... | custom-source | 2025-02-12T13:43:40.959591 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/010104s023lbl.pdf', 'application_number': 10104, 'submission_type': 'SUPPL ', 'submission_number': 23} |
10,738 |
NDA 10151 Dilantin (Phenytoin Sodium Injection, USP)
FDA Approved Labeling Text dated 02/2013
Page 1 of 15
Parenteral
Dilantin®
(Phenytoin Sodium Injection, USP)
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID
INFUSION
The rate of intravenous Dilantin administration sho... | custom-source | 2025-02-12T13:43:41.086924 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010151s037lbl.pdf', 'application_number': 10151, 'submission_type': 'SUPPL ', 'submission_number': 37} |
10,739 |
NDA 08762 Dilantin-125 (Phenytoin Oral Suspension, USP)
FDA Approved Labeling Text dated 04/2014
Dilantin-125®
(Phenytoin Oral Suspension, USP)
(FOR ORAL ADMINISTRATION ONLY; NOT FOR PARENTERAL USE)
DESCRI... | custom-source | 2025-02-12T13:43:41.554012 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s051,010151s039lbl.pdf', 'application_number': 10151, 'submission_type': 'SUPPL ', 'submission_number': 39} |
10,742 |
NDA 010155/S-022
NDA 010155/ S-023
FDA Approved Labeling Text dated 11/10/2011
Page 1
MYTELASE®
AMBENONIUM
CHLORIDE
DESCRIPTION
MYTELASE, brand of ambenonium chloride, is [Oxalylbis (iminoethylene)] bis[(o
chlorobenzyl) diethylammonium] dichloride, a white crystalline powder, soluble in water ... | custom-source | 2025-02-12T13:43:41.554370 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010155s023lbl.pdf', 'application_number': 10155, 'submission_type': 'SUPPL ', 'submission_number': 23} |
10,741 |
structural formula
Dilantin-125®
(Phenytoin Oral Suspension, USP)
(FOR ORAL ADMINISTRATION ONLY; NOT FOR PARENTERAL USE)
DESCRIPTION
Dilantin (phenytoin) is related to the barbiturates in chemical structure, but has a five-membered ring. The
chemical name is 5,5-... | custom-source | 2025-02-12T13:43:41.578490 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s055,010151s042lbl.pdf', 'application_number': 10151, 'submission_type': 'SUPPL ', 'submission_number': 42} |
10,740 |
Dilantin-125®
(Phenytoin Oral Suspension, USP)
(FOR ORAL ADMINISTRATION ONLY; NOT FOR PARENTERAL USE)
DESCRIPTION
Dilantin (phenytoin) is related to the barbiturates in chemical structure, but has a five-membered ring. The
chemical name is 5,5-diphenyl-2,4 imid... | custom-source | 2025-02-12T13:43:41.783598 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s054,010151s041lbl.pdf', 'application_number': 10151, 'submission_type': 'SUPPL ', 'submission_number': 41} |
10,744 |
T2006-56
Ritalin® hydrochloride
methylphenidate hydrochloride
tablets USP
Ritalin-SR®
methylphenidate hydrochloride USP
sustained-release tablets
Rx only
Prescribing Information
DESCRIPTION
Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous... | custom-source | 2025-02-12T13:43:42.057860 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf', 'application_number': 10187, 'submission_type': 'SUPPL ', 'submission_number': 66} |
10,743 |
NDA 010155/S-024 Mytelase tablet
FDA approved labeling text dated Nov 2014
Page 1
MYTELASE®
AMBENONIUM
CHLORIDE
DESCRIPTION
MYTELASE, brand of ambenonium chloride, is [Oxalylbis (iminoethy... | custom-source | 2025-02-12T13:43:42.123694 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/010155s024lbl.pdf', 'application_number': 10155, 'submission_type': 'SUPPL ', 'submission_number': 24} |
10,745 |
T2006-56
Ritalin® hydrochloride
methylphenidate hydrochloride
tablets USP
Ritalin-SR®
methylphenidate hydrochloride USP
sustained-release tablets
Rx only
Prescribing Information
DESCRIPTION
Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous... | custom-source | 2025-02-12T13:43:42.124250 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf', 'application_number': 10187, 'submission_type': 'SUPPL ', 'submission_number': 67} |
10,747 |
company logo
Ritalin® hydrochloride
methylphenidate hydrochloride
tablets USP
Ritalin-SR®
methylphenidate hydrochloride USP
sustained-release tablets
Rx only
Prescribing Information
DESCRIPTION
Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system ... | custom-source | 2025-02-12T13:43:42.632623 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s072,018029s042lbl.pdf', 'application_number': 10187, 'submission_type': 'SUPPL ', 'submission_number': 72} |
10,748 |
Ritalin® hydrochloride
methylphenidate hydrochloride USP
tablets
Ritalin-SR®
methylphenidate hydrochloride USP
sustained-release tablets
Rx only
Prescribing Information
DESCRIPTION
Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS)
stimu... | custom-source | 2025-02-12T13:43:42.675736 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf', 'application_number': 10187, 'submission_type': 'SUPPL ', 'submission_number': 77} |
10,749 | NDA 10-402/S-046
Premarin
Intravenous
(conjugated estrogens, USP) for injection
Specially prepared for Intravenous & Intramuscular use
Rx only
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures,
includ... | custom-source | 2025-02-12T13:43:42.712227 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/010402S046lbl.pdf', 'application_number': 10402, 'submission_type': 'SUPPL ', 'submission_number': 46} |
10,746 |
T2007-23
Ritalin® hydrochloride
methylphenidate hydrochloride
tablets USP
Ritalin-SR®
methylphenidate hydrochloride USP
sustained-release tablets
Rx only
Prescribing Information
DESCRIPTION
Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous... | custom-source | 2025-02-12T13:43:42.945982 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,021284s011lbl.pdf', 'application_number': 10187, 'submission_type': 'SUPPL ', 'submission_number': 69} |
10,751 | 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 | 2025-02-12T13:43:43.140194 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/10515s22lbl.pdf', 'application_number': 10515, 'submission_type': 'SUPPL ', 'submission_number': 22} |
10,752 |
wEN-3173v02
Page 1 of 6
Isuprel™
Rx only
Isoproterenol Hydrochloride Injection, USP
Sterile Injection
DESCRIPTION
Isoproterenol hydrochloride is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride,
a synthetic sympathomimetic amine that is structurally related... | custom-source | 2025-02-12T13:43:43.268560 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010515s031lbl.pdf', 'application_number': 10515, 'submission_type': 'SUPPL ', 'submission_number': 31} |
10,753 |
Celontin®
(Methsuximide Capsules, USP)
DESCRIPTION
Celontin (methsuximide) is an anticonvulsant succinimide, chemically designated as N,2-Dimethyl-2
phenylsuccinimide, with the following structural formula: ... | custom-source | 2025-02-12T13:43:43.272597 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010596s22lbl.pdf', 'application_number': 10596, 'submission_type': 'SUPPL ', 'submission_number': 22} |
10,750 |
Premarin®
Intravenous
(conjugated estrogens, USP) for injection
Specially prepared for Intravenous & Intramuscular use
Rx only
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST
CANCER and PROBABLE DEMENTIA
Estrogen-Alone Therapy
Endometrial Cancer
There is an incr... | custom-source | 2025-02-12T13:43:43.275513 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/010402s063lbl.pdf', 'application_number': 10402, 'submission_type': 'SUPPL ', 'submission_number': 63} |
10,757 | TESSALON®
100 mg Perles
200 mg Capsules
(benzonatate, USP)
DESCRIPTION
TESSALON, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p
(butylamino) benzoate; with a molecular weight of 603.7.
structural formula
H3
Each
Benzonatate, USP 100 mg
Each TESSALON Capsule c... | custom-source | 2025-02-12T13:43:43.545374 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf', 'application_number': 11210, 'submission_type': 'SUPPL ', 'submission_number': 53} |
10,754 | 1
PRESCRIBING INFORMATION
1
LEUKERAN®
2
(chlorambucil)
3
Tablets
4
5
WARNING
6
LEUKERAN (chlorambucil) can severely suppress bone marrow function. Chlorambucil is a
7
carcinogen in humans. Chlorambucil is probably mutagenic and teratogenic in humans.
8
Chlorambucil produces human infertility (see WARNINGS and PRECAUTIO... | custom-source | 2025-02-12T13:43:43.663467 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/10669slr028_leukeran_lbl.pdf', 'application_number': 10669, 'submission_type': 'SUPPL ', 'submission_number': 28} |
10,756 |
NDA 11-011/S-070
NDA 11-011/S-071
Page 3
FDA edits are double underlined.
robaxin® (methocarbamol tablets, USP)
500 mg
robaxin®-750 (methocarbamol tablets, USP)
750 mg
PC4449B
Rev. 02/03
Rx Only
DESCRIPTION
robaxin®/robaxin®-750 (methocarbamol t... | custom-source | 2025-02-12T13:43:43.752368 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/011011Orig1s070s071lbl.pdf', 'application_number': 11011, 'submission_type': 'SUPPL ', 'submission_number': 70} |
10,755 | NDA 10-926/S-030
Page 3
Phenergan
(promethazine HCI)
Tablets and Suppositories
only
DESCRIPTION
Each tablet of Phenergan contains 12.5 mg, 25 mg, or 50 mg promethazine HCl. The inactive
ingredients present are lactose, magnesium stearate, and methylcellulose. Each dosage strength also
contains the fol... | custom-source | 2025-02-12T13:43:43.759942 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/10926s030lbl.pdf', 'application_number': 10926, 'submission_type': 'SUPPL ', 'submission_number': 30} |
10,759 |
Kayexalate®
SODIUM POLYSTYRENE SULFONATE, USP
Cation-Exchange Resin
DESCRIPTION
KAYEXALATE, brand of sodium polystyrene sulfonate is a benzene, diethenyl-polymer, with
ethenylbenzene, sulfonated, sodium salt and has the following structural formula: Structural Formula
The drug is a cream to ... | custom-source | 2025-02-12T13:43:43.995483 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011287s022lbl.pdf', 'application_number': 11287, 'submission_type': 'SUPPL ', 'submission_number': 22} |
10,760 |
NDA 11-340/S-016
Page 3
CERUMENEX® EARDROPS
(triethanolamine polypeptide oleate-condensate)
This product contains dry natural rubber
064550-OC-001
IT00412
DESCRIPTION
CERUMENEX Eardrops contain triethanolamine Polypeptide Oleate-Condensate (10%).
Inactive Ingredients: Chlorobutanol... | custom-source | 2025-02-12T13:43:44.075973 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/11340s16lbl.pdf', 'application_number': 11340, 'submission_type': 'SUPPL ', 'submission_number': 16} |
10,761 | NDA 11-522
Confidential
ADDERALL® CII
Rx ONLY
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG
DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE
PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR
NON-T... | custom-source | 2025-02-12T13:43:44.108283 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf', 'application_number': 11522, 'submission_type': 'SUPPL ', 'submission_number': 32} |
10,758 | PAGE 1
TRILAFON TABLETS & TRILAFON INJECTION
FINAL PRINTED LABELING
1
TRILAFON
1
brand of perphenazine, USP
2
Tablets,
3
Injection
4
5
DESCRIPTION TRILAFON products contain perphenazine, USP (4-[3-(2-
6
chlorophenothiazin-10-yl)propyl]-1-piper-azineethanol), a piperazinyl phenothiazine
7
having the chemical formula... | custom-source | 2025-02-12T13:43:44.127170 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/10775s311213s24lbl.pdf', 'application_number': 11213, 'submission_type': 'SUPPL ', 'submission_number': 24} |
10,763 |
Adderall® CII (Dextroamphetamine Saccharate, Amphetamine Aspartate,
Dextroamphetamine Sulfate and Amphetamine Sulfate Table... | custom-source | 2025-02-12T13:43:44.685316 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s042lbl.pdf', 'application_number': 11522, 'submission_type': 'SUPPL ', 'submission_number': 42} |
10,764 |
... | custom-source | 2025-02-12T13:43:44.693065 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011525s027lbl.pdf', 'application_number': 11525, 'submission_type': 'SUPPL ', 'submission_number': 27} |
10,762 | NDA 11-522/S-034 and S-037
NDA 21-303/S-013
Page 3
ADDERALL® CII
Rx ONLY
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG
DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID
TO THE POSSIBILITY OF SUBJECTS OBTAININ... | custom-source | 2025-02-12T13:43:44.725413 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf', 'application_number': 11522, 'submission_type': 'SUPPL ', 'submission_number': 34} |
10,765 | N 11-559/S-037
Page 4
4
BREVITAL® SODIUM
METHOHEXITAL SODIUM FOR INJECTION, USP
For Intravenous Use in Adults
For Rectal and Intramuscular Use Only in Pediatric Patients
WARNING
Brevital should be used only in hospital or ambulatory care settings that provide for
continuou... | custom-source | 2025-02-12T13:43:44.735805 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11559slr037_brevital_lbl.pdf', 'application_number': 11559, 'submission_type': 'SUPPL ', 'submission_number': 37} |
10,769 |
DIABINESE®
(chlorpropamide)
TABLETS, USP
For Oral Use
DESCRIPTION
DIABINESE® (chlorpropamide), is an oral blood-glucose-lowering drug of the sulfonylurea
class. Chlorpropamide is 1-[(p-Chlorophenyl)sulfonyl]-3-propylurea, C10H13ClN2O3S, and has
the structural f... | custom-source | 2025-02-12T13:43:44.975974 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011641s066lbl.pdf', 'application_number': 11641, 'submission_type': 'SUPPL ', 'submission_number': 66} |
10,766 |
BREVITAL® SODIUM
METHOHEXITAL SODIUM FOR INJECTION, USP Logo
For Intravenous Use in Adults
For Rectal and Intramuscular Use Only in Pediatric Patients
WARNING
Brevital should be used only in hospital or ambulatory care settings that provide for
continuous monitoring of respiratory (e.g. pulse ... | custom-source | 2025-02-12T13:43:45.065914 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/011559s041lbl.pdf', 'application_number': 11559, 'submission_type': 'SUPPL ', 'submission_number': 41} |
10,768 |
DIABINESE®
(chlorpropamide)
TABLETS, USP
For Oral Use
DESCRIPTION
DIABINESE® (chlorpropamide), is an oral blood-glucose-lowering drug of the sulfonylurea
class. Chlorpropamide is 1-[(p-Chlorophenyl)sulfonyl]-3-propylurea, C10H13ClN2O3S, and has
the structural f... | custom-source | 2025-02-12T13:43:45.146337 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011641s065lbl.pdf', 'application_number': 11641, 'submission_type': 'SUPPL ', 'submission_number': 65} |
10,771 | 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 | 2025-02-12T13:43:45.238888 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf', 'application_number': 11665, 'submission_type': 'SUPPL ', 'submission_number': 15} |
10,770 |
TABLETS
DECADRON... | custom-source | 2025-02-12T13:43:45.328693 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011664s063lbl.pdf', 'application_number': 11664, 'submission_type': 'SUPPL ', 'submission_number': 63} |
10,767 |
1
KENALOG OINTMENTS
Rx only
Triamcinolone Acetonide Ointment USP
0.025%, 0.1%, 0.5%
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-
inflammatory and antipruritic agents. The steroids in this class include triamcinolone
acetonide. Triamcinol... | custom-source | 2025-02-12T13:43:45.439630 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/011600s026lbl.pdf', 'application_number': 11600, 'submission_type': 'SUPPL ', 'submission_number': 26} |
10,772 | NDA 11-689/S-024
Page 3
Phenergan®
(promethazine HCI)
Tablets and Suppositories
only
DESCRIPTION
Each tablet of Phenergan contains 12.5 mg, 25 mg, or 50 mg promethazine HCl. The inactive
ingredients present are lactose, magnesium stearate, and methylcellulose. Each dosage strength also
contains the foll... | custom-source | 2025-02-12T13:43:45.564765 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11689s024lbl.pdf', 'application_number': 11689, 'submission_type': 'SUPPL ', 'submission_number': 24} |
10,773 |
1
003466/September 2006
OPANA®
(Oxymorphone Hydrochloride) INJECTION
1mg/mL
CII
Opioid
Analgesic
Rx only
DESCRIPTION
OPANA (oxymorphone hydrochloride) Injection, is a semi-synthetic opioid analgesic.
OPANA Injection is available in 1 mg/mL, 1 mL ampules of oxymorphone hydrochloride.
In ad... | custom-source | 2025-02-12T13:43:45.756703 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011707s031lbl.pdf', 'application_number': 11707, 'submission_type': 'SUPPL ', 'submission_number': 31} |
10,776 | Page 1
Rev. November 2003
TENUATE® IV
(diethylpropion hydrochloride USP)
immediate-release
25 mg tablets
TENUATE® DOSPAN® IV
(diethylpropion hydrochloride USP)
controlled-release
75 mg tablets
DESCRIPTION
TENUATE® is available for oral administration in immediate-release tablets containing 25 mg
... | custom-source | 2025-02-12T13:43:45.791883 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11722s029,12546s032lbl.pdf', 'application_number': 11722, 'submission_type': 'SUPPL ', 'submission_number': 29} |
10,774 |
1
METHOTREXATE SODIUM
FOR INJECTION
Rx only
WARNINGS
METHOTREXATE SHOULD BE USED ONLY BY PHYSICIANS WHOSE KNOWLEDGE
AND EXPERIENCE INCLUDE THE USE OF ANTIMETABOLITE THERAPY.
BECAUSE OF THE POSSIBILITY OF SERIOUS TOXIC REACTIONS (WHICH CAN BE
FATAL):
METHOTREXATE SHOULD BE USED ONLY IN LIFE THREATENING NEO... | custom-source | 2025-02-12T13:43:46.074456 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11719slr106_methotrexate_lbl.pdf', 'application_number': 11719, 'submission_type': 'SUPPL ', 'submission_number': 106} |
10,775 |
c
o
mpany logo
Methotrexate Injection, USP
(Contains Preservative)
WARNINGS
• FOR INTRATHECAL AND HIGH-DOSE THERAPY, USE THE PRESERVATIVE-FREE
FORMULATION OF METHOTREXATE. DO... | custom-source | 2025-02-12T13:43:46.074858 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011719s122lbl.pdf', 'application_number': 11719, 'submission_type': 'SUPPL ', 'submission_number': 122} |
10,777 |
Depo-Medrol®
methylprednisolone acetate injectable suspension, USP
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
Not For Intravenous Use
DESCRIPTION
DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft
... | custom-source | 2025-02-12T13:43:46.209022 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf', 'application_number': 11757, 'submission_type': 'SUPPL ', 'submission_number': 85} |
10,778 |
DEPO-MEDROL®
(methylprednisolone acetate injectable suspension, USP)
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
Not For Intravenous Use
DESCRIPTION
DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra
articular, soft ti... | custom-source | 2025-02-12T13:43:46.368327 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011757s103lbl.pdf', 'application_number': 11757, 'submission_type': 'SUPPL ', 'submission_number': 103} |
10,779 | NDA 11-790/S-046
Page 3
Additions are underlined and deletions are strikethrough
ROBAXIN Injectable
(methocarbamol injection, USP)
Rx Only
DESCRIPTION
ROBAXIN (methocarbamol injection, USP) Injectable, a carbamate derivative of guaifenesin, is a
central nervous system (CNS) depressant with sedative an... | custom-source | 2025-02-12T13:43:46.428912 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11790slr046_robaxin_lbl.pdf', 'application_number': 11790, 'submission_type': 'SUPPL ', 'submission_number': 46} |
10,780 | IN-090H2-14
Rev. 5/05
SOMA®
(carisoprodol)
Tablets, USP
DESCRIPTION
`SOMA' (carisoprodol) Tablets, USP is available as 350 mg round, white tablets.
Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate.
Carisoprodol is a white, crystalline powder, having a mild, characteri... | custom-source | 2025-02-12T13:43:46.493504 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011792s035lbl.pdf', 'application_number': 11792, 'submission_type': 'SUPPL ', 'submission_number': 35} |
10,781 |
PROVERA®
(medroxyprogesterone acetate tablets, USP)
WARNINGS
CARDIOVASCULAR AND OTHER RISKS
Estrogens with progestins should not be used for the prevention of cardiovascular disease
or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders
and Dementia.)
The Women’s Health Initiative (WHI) es... | custom-source | 2025-02-12T13:43:46.633052 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011839s071lbl.pdf', 'application_number': 11839, 'submission_type': 'SUPPL ', 'submission_number': 71} |
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