http://www.fda.gov/cder/orange/appendix_a.txt IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, BACITRACIN ZINC NEOSPORIN, GRAMICIDIN NEOSPORIN, NEOMYCIN SULFATE (OTC) NEOTHYLLINE, DYPHYLLINE NEOTRIZINE, TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE; SULFAMETHAZINE) NEPHRAMINE 5.4%, AMINO ACIDS NEPHROFLOW, IODOHIPPURATE SODIUM, I-123 NEPTAZANE, METHAZOLAMIDE NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE...
DDPA August 1996 74-635 NAPROXEN SODIUM NOVOPHARM NAPROXEN SODIUM 20-AUG-96 (TABLET) SCARBOROUGH, ONTARIO 220MG CANADA (NONSTEROIDAL ANTI-INFLAMMATORY) 74-570 ACYCLOVIR ROXANE LABS ACYCLOVIR 30-AUG-96 (CAPSULE) COLUMBUS, OH 200MG 43216 (ANTIVIRAL) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 08-678 ISONIAZID EON MANUFACTURE LABS ISONIAZID 01-AUG-96 (TABLET) LAURELTON, NY 100MG 11413 300MG (LABELING...
August Drug Approvals Original Application #: 020508 Approval Date: 29-AUG-96 Trade Name: LAC-HYDRIN Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: BRISTOL MYERS CO Active Ingredient(s): AMMONIUM LACTATE OTC/RX Status: RX Indication(s): ICHTHYOSIS VULGARIS AND XEROSIS Original Application #: 020532 Approval Date: 26-AUG-96 Trade Name: IVY BLOCK Chemical Type: 1 Therapeutic...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt API DIVISION" "AMOXICILLIN MFG IN MEXICO, MISSOURI" 13520 01-Sep-98 ANTIBIOTICOS TETRACYCLINE PHOSPHATE COMPLEX 13521 01-Sep-98 KYOWA HAKKO MITOMYCIN 13523 01-Sep-98 GIST BROCADES (IT) NYSTATIN 13527 01-Sep-98 BRISTOL MYERS SQUIBB INDUSTRIAL DIV AMIKACIN SULFATE 13535 01-Sep-98 MEIJI SEIKA KAISHA L PENICILLIN G PROCAINE 13536 01-Sep-98 ALPHARMA APS POLYMYXIN B ...
Prescription and OTC Drug Product List 6/2002 -D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
Prescription and OTC Drug Product List 5/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 5: January-May 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE - ADD - ALMOTRIPTAN MALATE CAPSULE; ORAL - ADD - TABLET; ORAL ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE - ADD - AXERT - DLT - + MIKART 150MG;180MG...
Prescription and OTC Drug Product List 2/2001 PEDIATRIC - ADD - @ 10MG;100MG N74080 001 - ADD - + ASTRAZENECA /1VIL;0.02MG/VIAL;0.001MG/VIAL; - ADD - MAR 25, 1994 - ADD - 5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL; - ADD - @ 25MG;100MG N74080 002 - ADD - 17MG/VIAL;0.2MG/VIAL; - ADD - MAR 25, 1994 - ADD - EQ 1MG BASE/VIAL;1.4MG/VIAL; - ADD - @ 25MG;250MG N74080 003 - ADD - EQ 1.2MG BASE/VIAL;0.7MG/VIAL; - ADD - MAR 25, 1994 - ADD - 7MG...
Prescription and OTC Drug Product List 11/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 11: November 1999 [ Prescription - OTC ] - ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ALBUTEROL SULFATE BUPROPION HYDROCHLORIDE SOLUTION; INHALATION TABLET; ORAL ALBUTEROL SULFATE - ADD - BUPROPION HCL - ADD - AN MORTON GROVE EQ 0.083% BASE N75394 001 - ADD - AB...
Drug Approvals November 1996 Application #: 050580; Efficacy Supplement #: 008 Type: SE1 to Original New Drug Application Approval Date: 01-NOV-96 Trade Name: AZACTAM Dosage Form: INJECTABLE Applicant: ER SQUIBB AND SONS INC Active Ingredient(s): AZTREONAM OTC/RX Status: RX Efficacy Claim: Expanded use of Azactam in pediatric patients Application #: 019918; Efficacy Supplement #: 004 Type: SE1 to Original New...
Drug Approvals - M NDA 13-422/S-035 4/17/03 - - - Maxipime (Cefepime Hydrochloride) Injection,-Rx Bristol-Myers Squibb NDA 50-679/S-21 3/17/03 3/26/03 3/26/03 Maxipime (Cefepime Hydrochloride) Injection,- Bristol-Myers Squibb NDA 50-679/S-009, S-014 and S-018 8/21/02 8/26/02 - Maxipime (Cefepime Hydrochloride) Injection Bristol-Myers Squibb NDA 50-679/S007 1/27/99 - - 7/18/01 Maxitrol (neomycin and ...
Prescription and Over-the-Counter Drug Product List: 2/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL -A- CODRIX -A- + ANDRX PHARMS 500MG;15MG N40447 001 FEB 26, 2003 FEB NEWA AZATHIOPRINE TABLET; ORAL AZASAN -A- AAIPHARMA LLC 25MG N75252 002 FEB 03, 2003 FEB NEWA -A- AB 50MG N75252 001 JUN 07, 1999 FEB NEWA -A- 75MG N75252 003 FEB 03, 2003 FEB NEWA -A- 100MG N75252 004 FEB 03, 2003...
author: AUTHOR
1997 Abbreviated New Drug Applications (Generic Drugs) 71804 5/29/1997 4/1/1999 Desmopressin Acetate Injection 4mg/ml [801 KB] Gensia Laboratories, LtdAcetate 1% and Pramoxine Hydrochloride 1% [1.8 MB] Schwartz Pharma 086457 10/1980 12/1/1997 Erythromycin Pledgets 2% (jar) [940 KB] Stiefel Laboratories 064126 7/3/1996 2/6/1998 Erythromycin Pledgets 2% ...
Prescription and OTC Drug Product List 7/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS 325MG;7.5MG...
Prescription and OTC Drug Product List 8/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 8: August 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MODURETIC 5-50 - ADD - AB MALLINCKRODT...
Prescription and OTC Drug Product List 6/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 6: June 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMINO ACIDS TABLET; ORAL INJECTABLE; INJECTION PERCOCET NOVAMINE 8.5% - ADD - AA ENDO PHARMS 325MG;5MG N40330 002 - DLT - @ PHARMACIA AND UPJOHN 8.5% N17957 002...
Prescription and OTC Drug Product List 1/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 1: January 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST PRESCRIPTION DRUG PRODUCT LIST 1 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'2000 - ADD - CALCIUM CHLORIDE CEFTIBUTEN DIHYDRATE - ADD -...
PDPL - ADD - + ADV MAGNETICS EQ 11.2MG IRON/ML N20416 001 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE - ADD - AUG 30, 1996 TABLET; ORAL-21 ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/35-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON LABS 0.035MG;1MG N72720 001 - DLT - DEC 30, 1991 INJECTABLE; INJECTION ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/50-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON...
Prescription Drug Product List 1/96 PRESCRIPTION DRUG PRODUCT LIST 16TH EDITION RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'96 ACETAMINOPHEN; CODEINE PHOSPHATE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE TABLET; ORAL - ADD - ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION; INTRAPERITONEAL - ADD - AA MIKART 300MG;60MG N89244 001 - ADD - DELFLEX W/ DEXTROSE 4.25% IN...
http://www.fda.gov/cder/rdmt/escy99ap.htm - - - - - - - - - - LEUPROLIDE ACETATE TAP HOLDINGS 20-708 04/13/98 02/11/99 SE8 5 N 10.0 Comparability demonstrated between 3.75 mg and 11.25 mg depot in the treatment of endometriosis and uterine fibroidsSULFATE 3M PHARMACEUTICALS 20-503 06/02/98 06/02/99 SE1 11 N 12.0 Provides for lowering the age from 12 years to 4 years and older for...
author: Darlene
FDA Drug Approvals List July 1999 Drug Approvals for July 1999 Definitions and Notes Original New Drug Applications Original Application #: 021057 Approval Date: 29-JUL-99 Trade Name: ANTAGON Chemical Type: 1 Therapeutic Potential: P Dosage Form: INJECTABLE Applicant: ORGANON INC Active Ingredient(s): GANIRELIX ACETATE OTC/RX Status: RX Indication(s): Provides for the inhibition of premature LH surges in women...
DDPA December 1995 20-545 PROCANBID PARKE DAVIS PROCAINAMIDE HYDROCHLORIDE 14-DEC-95 (TABLET, ANN ARBOR, MI 500MG EXTENDED RELEASE) 48106 1000MG (ANTIARRHYTHMIC) 20-518 RETROVIR GLAXO WELLCOME ZIDOVUDINE 19-DEC-95 (TABLET) RES TRIANGLE PK, NC 300MG 27709 (ANTIVIRAL) 20-535 BROMFENAC SODIUM WYETH AYERST BROMFENAC SODIUM 28-DEC-95 (CAPSULE) RADNOR, PA EQ 25MG BASE 19087 EQ 50MG BASE (NONSTEROIDAL ANTI...
DDPA October 1995 19-672 EFIDAC 24 ALZA BROMPHENIRAMINE MALEATE 20-OCT-95 PSEUDOEPHEDRINE/ PALO ALTO, CA 16MG BROMPHENIRAMINE 94303 PSEUDOEPHEDRINE (TABLET, HYDROCHLORIDE EXTENDED RELEASE) 240MG (ANTIHISTAMINE/DECONGESTANT) (OTC) 20-520 ZANTAC 75 GLAXO WELLCOME RANITIDINE HYDROCHLORIDE 23-OCT-95 (TABLET) RES TRIANGLE PK, NC EQ 75MG BASE 27709 (HISTAMINE H-2 RECEPTOR ANTAGONIST) (OTC) 20-298 ZYLOPRIM...
Drug Approvals for September 1997 The development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program Original Application #: 020857 Approval Date: 26-SEP-97 Trade Name: COMBIVIR Chemical Type: 4 Therapeutic Potential: P Dosage Form: TABLET Applicant: GLAXO WELLCOME INC Active Ingredient(s): LAMIVUDINE; ZIDOVUDINE OTC/RX Status: RX Indication(s): Treatment...
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices Conc.( equine) 3.00 mL Dipyridamole 0.14 mg Dobutamine HCI 0.90 mg 5.00 1.10 2.17 3.57 1.80 1.80 1.80 1.80 45.45 5.00 1.25 5.56 11.60 + 0.50 + 35.70 + 71.43 16.70 + 17.20 + 0.70 + 0.70 + 111.00 + 200.00 + 1.00 357.00 0.003 + 0.50 + 166.67 1.00 4.00 0.50 + 1.00 8.77 3.40 + 16.67 1.67 37.70 5.56 40 Dopamine HCI Dopamine HCl in Dextrose Doxapram HCI Injection Doxorubicin HCI for...
author: FDA / CBER
subject: December 1987 Guideline
Prescription and Over-the-Counter Drug Product List: 6/2003 4 >D> + ROBINS AH 325MG;60MG N84446 001 JUN DISC >A> @ 325MG;60MG N84446 001 JUN DISC ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE; ORAL DIAMOX >A> @ DURAMED PHARM BARR 500MG N12945 001 JUN CAHN >A> + 500MG N12945 003 APR 25, 1995 JUN CAHN >D> @ LEDERLE 500MG N12945 001 JUN CAHN >D> + 500MG N12945 003 APR 25, 1995 JUN CAHN TABLET; ORAL >A> AB DURAMED PHARM BARR 125MG N08943 001 JUN CAHN ...
author: AUTHOR
