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 3/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 3: March 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CAPSULE; ORAL CHLORIDE; SODIUM PHOSPHATE...
DRAXIS Health Inc. News Releases - - March 1, 2004 DRAXIS Approved to Market Skeletal Imaging Agent in USA MISSISSAUGA, Ontario, March 1, 2004 – DRAXIMAGE Inc., the radiopharmaceutical subsidiary of DRAXIS Health Inc.kit for the preparation of Technetium Tc 99m Medronate Injection ( 99m Tc ...
Drug Approvals - D Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted DMSA (Kit for the preparation of Tc99m Succimer for Injection), Rx Amersham Health NDA 17-944/S-018 11/24/03 11/25/03 - - Dacarbazine for Injection USP, 200 mg/vial, Rx Faulding Pharmaceutical Co
chrmscat.p65 page 1
author: cxm9300
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
Prescription and OTC Drug Product List 11/1997 Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 11: Jan '97 - Nov '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE AMANTADINE HYDROCHLORIDE TABLET; ORAL CAPSULE; ORAL PRECOSE - DLT - SYMADINE - DLT - BAYER 25MG N20482 004 - DLT - AB SOLVAY 100MG N71000 001 - DLT - MAY 29, 1997 - DLT - SEP 04,...
Prescription and OTC Drug Product List 1/1998 IRRIGANT AEROSOL, METERED; INHALATION - DLT - AT GLAXO WELLCOME EQ 40MG BASE/ML; ATROVENT - DLT - 200,000 UNITS/ML N60707 001 - DLT - BOEHRINGER INGELHEIM 0.018MG/INH N19085 001 - ADD - AT MONARCH PHARMS EQ 40MG BASE/ML; - DLT - DEC 29, 1986 - ADD - 200,000 UNITS/ML N60707 001 - ADD - + 0.018MG/INH N19085 001 - ADD - DEC 29, 1986 PERMETHRIN ISOSULFAN BLUE CREAM; TOPICAL ELIMITE...
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...
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/da/ddpa93.wpd 19 050 SUFENTA JANSSEN SUFENTANIL CITRATE 03 19 93 (INJECTABLE) PISCATAWAY, NJ EQ 0.05MG BASE/ML 08854 (REVISED LABELING DESCRIPTION; CLINICAL PHARMACOLOGY; CLINICAL STUDIES; INDICATIONS AND USAGE; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; OVERDOSAGE; DOSAGE AND ADMINISTRATION) 19 898 PRAVACHOL BRISTOL MYERS SQUIBB PRAVASTATIN SODIUM 03 22 93 (TABLET) PRINCETON, NJ 10MG 08543 20MG...
What's new at CDER by Date - U.S
author: Paul Stauffer
LIST OF APPROVED DRUGS FOR WHICH ADDITIONAL PEDIATRIC INFORMATION Medical Imaging And Radiopharmaceutical Drug Products Technetium Tc -99m Apcitide Scintigraphic imaging of acute venous thrombosis in the lower extremities in patients who have signs and symptoms of acute venous thrombosisTechnetium Tc -99m Disofenin Hepatobiliary imaging agent
may20lst.PDF 98N- 0056 May 20, 1998 Page 11 Drug Name Potential pediatric use limited to approved indications Age Group In Which More Information Needed birth to 1 mos 1 mos to 2 yrs 2 to 12 years 12 to 16 years Technetium Tc - 99m Mebrofenin Radioactive diagnostic for hepatobiliary imaging Yes Yes Yes Yes Technetium Tc - 99m Medronate Bone imaging agent to...
author: Unknown
may20lst.PDF page 11
author: Unknown
DRAXIS Health Inc. - The DRAXIMAGE mission is to discover, develop, manufacture and market innovative radiopharmaceuticals.kits for use with Technetium -99m including MAA, MDP, DTPA and Glucoheptonate.
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...
