http://www.fda.gov/cder/orange/appendix_a.txt PEDIATRIC, ASCORBIC ACID M.V.I.-12 LYOPHILIZED, ASCORBIC ACID M.V.I.-12, ASCORBIC ACID MACROBID, NITROFURANTOIN MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE MACROTEC, TECHNETIUM TC -99M ALBUMIN AGGREGATED KIT MAGNACORT, HYDROCORTAMATE HYDROCHLORIDE MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE IN PLASTIC CONTAINER,...
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...
DRAXIS Health Inc. The newly formulated diagnostic product, called MDP -25, is a kit for the preparation of Technetium Tc 99m Medronate Injection ( 99m Tc -Methylene Diphosphonic Acid Kit). MDP -25 formulation provides an increased ability to more effectively image the extremities of the skeleton, particularly hands and feet.
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...
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...
1996 and Older - New Drug Application (NDA) 20195/S-002 5/20/96 8/2/99 Fragmin/dalteparin sodium Injection [1.5 MB] Pharmacia and Upjohn 020287/S005 9/24/1996 2/4/1998 Heptolite, Kit for the Preparation of Technetium Tc 99m Disofenin Merck 18467/ S-13 & S-14 12/29/1993 8/5/2003 Humulin R Lilly 018870/S37 1/11/1994 6/17/2003 Hydrocortisone and Acetic Acid - Morton Grove Pharmaceuticals 040168 08/30/1996...
What's new at CDER by Date - U.S
author: Paul Stauffer
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...
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. It is formulated as an easy-to-use lyophilized kit for reconstitution with Technetium -99m radioisotope, and is currently in the latter stages of two Phase III clinical trials in Canada and the United States.kit for reconstitution with Technetium -99m and is under development and...
DRAXIS Health Inc. News Releases - - February 16, 2005 DRAXIS Diagnostic Radiopharmaceutical Approved in First European Country Approval in Netherlands for MAA diagnostic kit for lung imaging paves way for additional products and countries across Europe MISSISSAUGA, Ontario – February 16, 2005 – DRAXIS Health Inc.
3887_Draxis_cover&spine Fibrimage ® is a product that links the radioactive isotope technetium - 99m (Tc - 99m) with the fibrin binding domain of human fibronectin, a recombinant polypeptide that has a high binding affinity for the primary component in an actively forming clot, or thrombus, which can form in the deep veins of the lower legsTc ...
author: Charlyn Wee
3887_Draxis_cover&spine Fibrimage ® is a product that links the radioactive isotope technetium - 99m (Tc - 99m) with the fibrin binding domain of human fibronectin, a recombinant polypeptide that has a high binding affinity for the primary component in an actively forming clot, or thrombus, which can form in the deep veins of the lower legsTc ...
author: Charlyn Wee
Nofetumomab Verluma Statistical Review Statistical Review and Evaluation Date: i Ai& 4 1995 E& AA: 94- 0308 : Thomae/ Boehringer Ingelheim (BI) GmbH me of Pro& g& i e-, the NR- LU- 10 Imaging AgentMDP) and imaging procedure over several dayskit for the preparation of Technetium Tc ...
author: CBER
doi:10.1016/S0969-8051(03)00028-3 page 7
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...
Draxis Form 20-F for FYE 1201 as Filed SEDAR.DOC page 18
author: ChrisO
Prescription and OTC Drug Product List 7/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 7: July 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE - ADD - CALFACTANT TABLET; ORAL - ADD - INJECTABLE; INJECTION BUTALBITAL,ACETAMINOPHEN AND CAFFEINE - ADD - INFASURF PRESERVATIVE FREE - ADD - AB + MIKART 500MG...
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
