1996 and Older - New Drug Application (NDA) New Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
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...
Prescription and OTC Drug Product List 1/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 1: January 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE...
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...
pvv5303.tmp Formulations : Invamed's formulations for its Orphenadrine Citrate, Aspirin and Caffeine 50 mg/ 770 mg/ 60 mg and 25 mg/ 385 mg/ 30 mg Tablets are shown below: Invagesic Invagesic Forte 25/ 385/ 30 mg 50/ 770/ 60 mg Component MG Per Tablet MG Per Tablet (Green Laver) Orphenadrine Citrate, USP 25.0 50.0 Caffeine, USP 30.0 60.0...
author: fda
pvv5303.tmp page 24
author: fda
pvv5303.tmp page 23
author: fda
pvv5303.tmp page 22
author: fda
pvv5303.tmp page 13
author: fda
pvv5303.tmp page 12
author: fda
pvv5303.tmp page 5
author: fda
pvv5303.tmp page 9
author: fda
pvv5303.tmp page 7
author: fda
pvv5303.tmp page 1
author: fda
Drug Approvals - O Roxane Laboratories NDA 20-315/S-006 3/30/01 5/1/01 - - Orphenadrine Citrate Injection, 30 mg/mL, Rx Bedford Laboratories ANDA 40-463 3/4/03 - - Orphenadrine Citrate Extended-Release Tablets, 100 mg, Rx Impax Laboratories, IncOrphenadrine Citrate Extended-Release Tablets, 100 mg, Rx Approved 1/29/1999 Kiel...
1997 Warning Letters and Notice of Violation Letters to Pharmaceutical Companies Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 1997 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 2900 06-Apr-77 AVENTIS PHARMA SA HYDROCORTISONE HEMISUCCINATE 2904 13-Apr-77 ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV ERTHROMYCIN PHOSPHATE 2911 12-Apr-77 ORGAMOL SA BUPIVACAINE HCL 2922 02-May-77 AVENTIS PHARMA SA 6-ALPHA-METHYLPREDNISOLONE HEMISUCCINATE 2938 09-May-77 PROCOS SPA PHENYLTOLOXAMINE CITRATE 2942 09-May-77 PROCOS SPA ORPHENADRINE HYROCHLORIDE & ...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls AVENTIS PHARMA SA HYDROCORTISONE HEMISUCCINATE ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV ERTHROMYCIN PHOSPHATE ORGAMOL SA BUPIVACAINE HCL AVENTIS PHARMA SA 6-ALPHA-METHYLPREDNISOLONE HEMISUCCINATE PROCOS SPA PHENYLTOLOXAMINE CITRATE PROCOS SPA ORPHENADRINE HYROCHLORIDE & ORPHENADRINE CITRATE BASF CORP POVIDONE-IODINE LEK PHARMACEUTICALS D.D
Prescription and Over-the-Counter Drug Product List: 3/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG...
author: AUTHOR
1997 Abbreviated New Drug Applications (Generic Drugs) Generic Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information OfficeCaffeine and Dihydrocodeine Bitartrate capsules 356.4mg/30mg/16mg [2 MB] Mikart, Inc
FDA Drug Approvals List- May 1998 In this setting, INTEGRILIN has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction, or need for urgent intervention Original Application #: 020774 Approval Date: 15-MAY-98 Trade Name: PERIO CHIP Chemical Type: 3 Therapeutic Potential: S Dosage Form: CHIP Applicant: PERIO PRODUCTS LTD Active Ingredient(s): CHLORHEXIDINE GLUCONATE OTC/RX Status:...
FDA Drug Approvals List- April 1999 Original Application #: 050760 Approval Date: 15-APR-99 Trade Name: AMOXIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: SUSPENSION Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): AMOXICILLIN OTC/RX Status: RX Indication(s):For the use of Amoxil for oral suspension 200mg/5mL and 400mg/5mL in divided doses q12h Original Application #: 020924 Approval Date:...
http://www.fda.gov/cber/gdlns/guidelst.txt Drug Advertising and Promotional Labeling DDMAC 2 Dissemination of Reprints of Certain October 8, 1996 Advertising Do Published, Original Data Funded Dissemination of Reference October 8, 1996 Do Do Texts Antifungal (topical) February 24, 1990 Biopharmaceutic Drug Information Branch (Draft) Antifungal (vaginal) February 24, 1990 Do Do Food-Effect Bioavailability and December 30, 1997...
74988APP.LTR.DOC ANDA 74- 988 April 30, 1999 Jerome Stevens Pharmaceuticals, IncOrphenadrine Citrate, Aspirin, and Caffeine Tablets, 25 mg/ 385 mg/...
author: Unknown
74988APP.LTR.DOC page 1
author: Unknown
