What's new at CDER by Date New and Generic Drug Approvals Benazepril Hydrochloride Tablets, Mylan Pharmaceuticals Benazepril Hydrochloride Tablets, Ranbaxy Benazepril Hydrochloride Tablets, Andrx Pharmaceuticals Benazepril Hydrochloride Tablets, Genpharm Benazepril Hydrochloride Tablets, Ivax Pharmaceuticals Benazepril Hydrochloride Tablets, Teva Pharmaceuticals Benazepril ...
author: Paul Stauffer
http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
1999 Warning Letters and Untitled Letters to Pharmaceutical Companies DDMAC 1/21/99 1/26/99 Prograf (tacrolimus) capsules Fujisawa USA DDMAC 1/4/99 1/11/99 Remeron (mitrazapine) tablets Organon DDMAC 1/5/99 1/14/99 Risperdal (risperidone) tablets and oral solution Janssen Research DDMAC 1/5/99 1/14/99 Trivora, Zovia, Necon, Levora, Nor-QD Tablets Watson Laboratories DDMAC 1/26/99 2/12/99 February Arava (leflunomide) tablets Hoechst Marion Roussel DDMAC...
First-Time Generics - January 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - January 2002 Generic Name Brand Name Approval Date 1 SULFASALAZINE DELAYED-RELEASE TABLETS, USP 500 MG AZULFIDINE EN-TABS 1/11/02 2 OFLOXACIN INJECTION 40 MG/ML (10 ML SINGLE-DOSE VIALS) FLOXIN I.VHYDROCHLORIDE TABLETS 500...
author: USERNAME
FDA Drug Approvals List July 2002 45 Dosage Form: INJECTABLE Applicant: XCEL PHARMACEUTICALS Active Ingredient(s): DIHYDROERGOTAMINE MESYLATE OTC/RX Status: RX Application #: 020449 Labeling Supplement #: 019 To Original New Drug Application Approval Date: 30-JUL-02 Trade Name: TAXOTERE Dosage Form: INJECTABLE Applicant: AVENTIS PHARMACEUTICALS INC Active Ingredient(s): DOCETAXEL OTC/RX Status: RX Application #:...
Prescription and OTC Drug Product List 1/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA KV PHARM 500MG/15ML;7.5MG/15ML N40366 001 JAN 23, 2002 JAN NEWA AMPHOTERICIN B INJECTABLE, LI COMPLEX; INJECTION ABELCET -A- + ELAN PHARMS 5MG/ML N50724 001 NOV 20, 1995 JAN CAHN -D- + LIPOSOME 5MG/ML N50724 001 NOV 20, 1995 JAN...
http://www.fda.gov/cder/foi/appletter/2001/65061ltr.pdf ANDA 65- 061 February 2, 2001 Ranbaxy Pharmaceuticals IncClindamycin Hydrochloride Capsules USP,...
http://www.fda.gov/cder/foi/appletter/2001/65061ltr.pdf page 1
Prescription and OTC Drug Product List 10/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 10: October 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE BENZYL PENICILLOYL-POLYLYSINE CAPSULE; ORAL INJECTABLE; INJECTION BUTALBITAL, ACETAMINOPHEN AND CAFFEINE PRE-PEN - ADD - AB WEST WARD 500MG;50MG;40MG N40261...
Prescription and OTC Drug Product List 8/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 8: August 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AZATHIOPRINE SODIUM CAPSULE; ORAL INJECTABLE; INJECTION FEMCET IMURAN - DLT - AB MALLINCKRODT 325MG;50MG;40MG N89102 001 - ADD - AP + FARO PHARMS EQ 100MG BASE...
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 -...
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...
FDA Drug Approvals List Active Ingredient(s): NEDOCROMIL SODIUM OTC/RX Status: RX Efficacy Claim: Extending the approved use to the pediatric population of 6-11 years of age Approvable Original New Drug Applications Original Application #: 019781 Approvable Date: 31-MAR-97 Trade Name: PROMETRIUM Dosage Form: CAPSULE Applicant: SCHERING PLOUGH CORP Active Ingredient(s): PROGESTERONE OTC/RX Status: RX...
FDA Drug Approvals List- March 1998 Drug Approvals for March 1998 Definitions and Notes March 1998 Original New Drug Applications Original Application #: 020827 Approval Date: 30-MAR-98 Trade Name: MONISTAT 3 Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: ADVANCED CARE PRODUCTS Active Ingredient(s): MICONAZOLE NITRATE OTC/RX Status: OTC Indication(s): For the over-the-counter treatment of...
FDA Drug Approvals List August 1999 Drug Approvals for August 1999 Definitions and Notes Original New Drug Applications Original Application #: 020984 Approval Date: 18-AUG-99 Trade Name: RAPLON Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: ORGANON INC SUB AKZO NOBEL INC Active Ingredient(s): RAPACURONIUM BROMIDE OTC/RX Status: RX Indication(s): For outpatients and inpatients as an...
DDPA December 1995 74-589 MINOXIDIL LEMMON MINOXIDIL 15-DEC-95 (SOLUTION) SELLERSVILLE, PA 2% 18960 (HAIR GROWTH STIMULATOR) 74-643 MINOXIDIL BAUSCH AND LOMB MINOXIDIL 22-DEC-95 (SOLUTION) TAMPA, FL 2% 33637 (HAIR GROWTH STIMULATOR) 74-418 CAPTOPRIL ENDO CAPTOPRIL 28-DEC-95 (TABLET) GARDEN CITY, NY 12.5MG 11530 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO...
DDPA October 1995 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 18-482 PROCARDIA PFIZER LABS NIFEDIPINE 04-OCT-95 (CAPSULE) NEW YORK, NY 10MG 10017 20MG (LABELING REVISION -- DESCRIPTION; CLINICAL PHARMACOLOGY; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; OVERDOSAGE) 19-386 BREVIBLOC OHMEDA PHARM ESMOLOL HYDROCHLORIDE 04-OCT-95 (INJECTABLE) LIBERTY CORNER, NJ 10MG/ML 07938 250MG/ML (LABELING REVISION...
DDPA February 1995 74-047 ZIDOVUDINE BARR ZIDOVUDINE 24-FEB-95 (C APSULE) POMONA, NY 100MG 10970 (ANTIVIRAL) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-970 NOLVADEX ZENECA PHARMS TAMOXIFEN CITRATE 01-FEB-95 (TABLET) WILMINGTON, DE EQ 10MG BASE 19850 (LABELING REVISION -- WARNINGS) 20-055 GLYBURIDE (MICRONIZED) HOECHST ROUSSEL GLYBURIDE 01-FEB-95 (TABLET) SOMERVILLE, NJ 1.5MG 08876 3MG (LABELING...
DDPA March 1996 74-488 RANITIDINE HCL GRANUTEC RANITIDINE HYDROCHLORIDE 05-MAR-96 (TABLET) WILSON, NC EQ 150MG BASE 27896 EQ 300MG BASE (HISTAMINE H-2 RECEPTOR ANTAGONIST) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 04-570 HEPARIN SODIUM UPJOHN HEPARIN SODIUM 04-MAR-96 (INJECTABLE) KALAMAZOO, MI 1,000 UNITS/ML 49001 5,000 UNITS/ML 10,000 UNITS/ML (LABELING REVISION -- WARNINGS; PRECAUTIONS;...
Drug Approvals for December 1997 Also provides for the addition of Haemophilus influenzae to the presently approved indication for secondary bacterial infections of acute bronchitis Application #: 020522 Efficacy Supplement#: 004 Type: SE1 to Original New Drug Application Approval Date: 17-DEC-97 Trade Name: NUTROPIN AQ Dosage Form: INJECTABLE Applicant: GENENTECH INC Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC...
Drug Approvals for July 1997 Drug Approvals for July 1997 Definitions and Notes July 1997 Original New Drug Applications Original Application #: 020701 Approval Date: 31-JUL-97 Trade Name: CRINONE Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: COLUMBIA RESEARCH LABORATORIES INC Active Ingredient(s): PROGESTERONE OTC/RX Status: RX Indication(s): Treatment of secondary amenorrhea Original...
Generic Names of Some Trade Name Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs -~ Generic Names of Some Trade Name Drugs - Generic Names of Some...
Some Trade Names of Generic Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs-~ Generic Names of Some Trade Name Drugs - Some Trade Names of...
Pneumocystis Pneumonia: Pneumonia: Merck Manual Home Edition Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
Toxoplasmosis: Parasitic Infections: Merck Manual Home Edition Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
