http://www.fda.gov/cder/orange/appendix_a.txt 400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE EC-NAPROSYN, NAPROXEN ECONAZOLE NITRATE, ECONAZOLE NITRATE ECONOCHLOR, CHLORAMPHENICOL ECONOPRED PLUS, PREDNISOLONE ACETATE ECONOPRED, PREDNISOLONE ACETATE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID EDETATE DISODIUM, EDETATE DISODIUM EDEX, ALPROSTADIL EDROPHONIUM CHLORIDE PRESERVATIVE FREE, EDROPHONIUM...
Prescription and Over-the-Counter Drug Product List: 11/2003 ACTHAR GEL >D> BC + QUESTCOR PHARMS 80 UNITS/ML N08372 008 NOV CTEC >A> + 80 UNITS/ML N08372 008 NOV CTEC CYTARABINE INJECTABLE; INJECTION >D> CYTARABINE >D> AP + GENSIA SICOR PHARMS 100MG/VIAL N16793 001 NOV DISC >D> AP + 500MG/VIAL N16793 002 NOV DISC >D> AP + 1GM/VIAL N16793 003 DEC 21, 1987 NOV DISC >D> AP + 2GM/VIAL N16793 004 DEC 21, 1987 NOV DISC >A> @ SICOR PHARMS 100MG/VIAL...
../99/50-778_Ellence_ Food and Drug Administration • Center for Drug Evaluation and Research Title Search Ellence (Epirubicin Hydrochloride) Injection Company:--Pharmacia & Upjohn Company Application No.:--50-778 Approval Date:-9/15/1999 Approval Letter(s) - Printed Labeling - Medical Review(s) Part 1 - Part 2 - Part 3 - Part 4 - Part 5 - Chemistry Review(s) - Pharmacology Review(s)...
author: USERNAME
Prescription and OTC Drug Product List 9/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 9: September 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE ATENOLOL CAPSULE; ORAL TABLET; ORAL - DLT - BUTALBITAL, ACETAMINOPHEN, CAFFEINE ATENOLOL - DLT - AB GRAHAM DM 325MG;50MG;40MG N88758 001 - ADD - MYLAN 25MG...
FDA Drug Approvals List August 1999 Drug Approvals for September 1999 Definitions and Notes Original New Drug Applications Original Application #: 021079 Approval Date: 24-SEP-99 Trade Name:ALAMAST Chemical Type: 1 Therapeutic Potential: P Dosage Form: SOLUTION Applicant: SANTEN INC Active Ingredient(s): PEMIROLAST POTASSIUM OTC/RX Status: RX Indication(s): For the prevention of itching of the eye due to allergic...
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...
Cancer: Breast Disorders: 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...
BioPortfolio Limited Commercial Insight: Cancer Market Top 20 Drugs - Supportive Care Grows the Cancer Market TABLE OF CONTENTS About Datamonitor Healthcare 2 CHAPTER 1 EXECUTIVE SUMMARY 3 CHAPTER 2 MARKET DEFINITION AND OVERVIEW 12 Scope 12 Market definition for this report 12 Cytotoxics 13 L1A – Alkylating agents 13 L1B – Antimetabolites 13 L1C – Vinca alkaloids and other plant products...
Report to the Nation: Drug Review Priority new drug approvals: Alitretinoin Amprenavir (2 dosage forms) Aspirin/extended release-dipyridamole Bexarotene Busulfan Caffeine citrate Cytarabine liposome Dalfopristin/quinupristin Epirubicin hydrochloride Ganirelix acetate Ketotifen fumarate Levonorgestrel Nedocromil sodium Nitric oxide Orlistat Oseltamivir phosphate Pemirolast potassium Pioglitazone hydrochloride...
author: OLIVERN
NMEs Approved in CY 1999 NMEs Approved in Calendar Year 1999 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date - - - - - - - 20-863 Cilostazol Pletal Tablet Otsuka Pharm 1S 01-15-1999 20-886 Alitretinoin Panretin Topical Gel Ligand Pharm 1-PV 02-02-1999 20-955 Sodium Ferric Gluconate Complex Ferrlicit Injectable R&D Labs 1P 02-18-1999 21-007 Amprenavir Agenerase...
author: Elaine Abraham
New Medicine, Inc. - Press Release April 30, 2003 FOR IMMEDIATE RELEASE CONTACT: Brandt Newcomer Tel: (949) 830-0448 FAX: (949) 830-0887 brandtn@newmedinc.com http://oncologyknowledgebase.net http://www.newmedinc.com Anticancer Agents From Antibiotic Sources - New Antibiotics, Analogs and Derivatives, and Targeted Cytotoxics - a Report From New Medicine LAKE FOREST, Calif., April 30 /PRNewswire/ -- Future Oncology, the premier...
http://www.newmedinc.com/futonc/sample.pdf These are being joined by newer cytotoxics such as carboplatin (Paraplatin; Bristol- Myers Squibb), oxaliplatin (Eloxatin; Sanofi- Synthelabo), gemcitabine (Gemzar; Lilly), epirubicin (Ellence; Pharmacia), paclitaxel, docetaxel (Taxotere; Aventis), and arsenic trioxide (Arsenox; Cell Therapeutics), among othersEpirubicin (1 mg/ ml or 2 mg/ ml in 50 or Among 122...
http://www.newmedinc.com/futonc/sample.pdf page 6
Ellence Consumer Information - You should not be given Ellence if you have had any of the following conditions: Low levels of white blood cells in the body Severe heart failure Recent heart attack Treatment in the past with this class of drugs (anthracyclines) up to the maximum total dose Allergic reactions to Ellence or other similar medications Severe liver problems Special Warning(s) with ...
CDER 1999 Report to the Nation 1999 new molecular entities: Alitretinoin (Panretin) Aminolevulinic acid hydrochloride (Levulan Kerastick) Amprenavir (Agenerase) Bexarotene (Targretin) Cilostazol (Pletal) Dalfopristin/ quinupristin (Synercid) Dexmedetomidine hydrochloride (Precedex) Dofetilide (Tikosyn) Doxercalciferol (Hectorol) Entacapone (Comtan) Epirubicin hydrochloride (Ellence) Exemestane ...
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
CDER 1999 Report to the Nation page 13
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
CDER 1999 Report to the Nation page 12
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
CDER 1999 Report to the Nation page 11
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
http://www.fda.gov/cder/foi/label/1999/50778lbl.pdf 7 8 DESCRIPTION 9 10 ELLENCE Injection (epirubicin hydrochloride injection) is an anthracycline cytotoxic agent 11 intended for intravenous administrationELLENCE is supplied as a sterile, clear, red solution and 12 is available in polypropylene vials containing 50 and 200 mg of epirubicin hydrochloride as a 13 preservative- free, ready- to- use solution
http://www.fda.gov/cder/foi/label/1999/50778lbl.pdf page 21
http://www.fda.gov/cder/foi/label/1999/50778lbl.pdf page 19
http://www.fda.gov/cder/foi/label/1999/50778lbl.pdf page 18
http://www.fda.gov/cder/foi/label/1999/50778lbl.pdf page 16
http://www.fda.gov/cder/foi/label/1999/50778lbl.pdf page 15
