Drug Approvals - O Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Ocufen Ophthalmic Solution, (0.03%) Allergan NDA 19-404/S020 8/25/03 8/28/03 8/28/03 - Ocufen Ophthalmic Solution (0.03%) Allergan NDA 19-404/S017 8/17/01 - 4/15/03 - Ocufen Ophthalmic Solution (0.03%) Allergan NDA 19-404/S014 7/30/01 - 4/15/03 - Ofloxacin Injection, 40 mg/mL packaged in 10 mL...
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...
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
ANDAs Approvals - June 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals June 2000 1
author: USERNAME
ANDA Approvals March 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - March 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-455 NOREPINEPHRINE BITARTRATE INJECTION, USP 1 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/4 ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INCORPHENADRINE CITRATE ...
author: OGD
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 N40441 001...
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 Office
FDA Drug Approvals List February 2000 - Drug Approvals for February 2000 Definitions and Notes Original New Drug Applications Original Application #: 021015 Approval Date: 28-FEB-00 Trade Name: ANDROGEL Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: UNIMED PHARMACEUTICALS INC Active Ingredient(s): TESTOSTERONE OTC/RX Status: RX Indication(s): For replacement therapy in males for conditions...
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 Bulk, Group C Meningococcal Polysaccharide Vaccine Group A Meningococcal Polysaccharide Vaccine Group C Meningococcal Polysaccharide Vaccine Group A and C Menotropin Meperidine HCl Injection Mephentermine Sulfate Mepivacaine HCl Mepivacaine HCl and Levonordefrin Meprobamate Injection Meprylcaine HCI and Epinephrine Mercaptomerin Sodium Mersalyl with theophylline Merethoxylline...
author: FDA / CBER
subject: December 1987 Guideline
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 page 4
author: FDA / CBER
subject: December 1987 Guideline
Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 30
author: FDA
Quarterly List of Guidance Documents at the Food and Drug Administration page 11
author: FDA
Prescription and OTC Drug Product List 6/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 6: June 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL OXYCODONE AND ACETAMINOPHEN CAPOZIDE 25/15 - ADD - AA DURAMED 325MG;5MG N40272 001 - ADD - AB BRISTOL...
Prescription and OTC Drug Product List 1/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 1: January 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE BENDROFLUMETHIAZIDE; NADOLOL CAPSULE; ORAL TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN CORZIDE - ADD - AA MALLINCKRODT 500MG;5MG N88956 001 - ADD -...
Prescription and OTC Drug Product List 6/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 6: June 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETOHEXAMIDE BLEOMYCIN SULFATE TABLET; ORAL INJECTABLE; INJECTION ACETOHEXAMIDE BLEOMYCIN - DLT - AB BARR 500MG N70870 001 - ADD - AP GENSIA SICOR PHARMS EQ 15 UNITS BASE/VIAL N65033 001 - DLT - FEB...
Prescription and OTC Drug Product List 3/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 3: March 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST LIST 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 3 / JAN'2000 - MAR'2000 ACETAMINOPHEN; BUTALBITAL AMINOPHYLLINE CAPSULE; ORAL TABLET; ORAL PHRENILIN...
Prescription and OTC Drug Product List 2/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 2: February 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CICLOPIROX TABLET; ORAL CREAM; TOPICAL LORTAB LOPROX - DLT - UCB 325MG;5MG N40099 001 - ADD - + AVENTIS PHARMS 0.77% N18748 001 - DLT - JUN 25, 1997 - ADD -...
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 BISOPROLOL...
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:...
FDA Drug Approvals List June 2000 - Drug Approvals for June 2000 Definitions and Notes Original New Drug Applications Original Application #: 020715 Approval Date: 15-JUN-00 Trade Name:TRELSTAR DEPOT Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: DEBIO RECHERCHE PHARMACEUTIQUE SA Active Ingredient(s): TRIPTORELIN PAMOATE OTC/RX Status: RX Indication(s): For the palliative treatment of...
FDA Drug Approvals List- January 1999 Drug Approvals for January 1999 Definitions and Notes January 1999 Original New Drug Applications Original Application #: 020781 Approval Date: 27-JAN-99 Trade Name: ZOFRAN ODT Chemical Type: Therapeutic Potential: Dosage Form: TABLET Applicant: GLAXO WELLCOME INC Active Ingredient(s): ONDANSETRON OTC/RX Status: RX Indication(s): For the prevention of chemotherapy and radiation...
