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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Healthtrust
Dow
AstraZeneca
QuintilesIMS
Medtronic
Johnson and Johnson
Daiichi Sankyo
Boehringer Ingelheim

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050629

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NDA 050629 describes DOXORUBICIN HYDROCHLORIDE, which is a drug marketed by Actavis Inc, Alvogen Inc, Amneal Pharms Co, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Labs Ltd, Pharmachemie Bv, Pharmacia And Upjohn, Sagent Pharms, Sandoz Inc, Sun Pharm Inds, Teva Pharms Usa, West-ward Pharms Int, Dr Reddys Labs Ltd, and Sun Pharma Global, and is included in twenty NDAs. It is available from twelve suppliers. Additional details are available on the DOXORUBICIN HYDROCHLORIDE profile page.

The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
Summary for 050629
Tradename:DOXORUBICIN HYDROCHLORIDE
Applicant:Pharmacia And Upjohn
Ingredient:doxorubicin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050629
Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 050629
Suppliers and Packaging for NDA: 050629
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 050629 NDA Pfizer Laboratories Div Pfizer Inc 0069-3030 N 0069-3030-20
DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 050629 NDA Pfizer Laboratories Div Pfizer Inc 0069-3031 N 0069-3031-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Dec 23, 1987TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML
Approval Date:May 3, 1988TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength150MG/75ML
Approval Date:Mar 28, 2011TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Fish and Richardson
Citi
Daiichi Sankyo
McKinsey
Covington
Federal Trade Commission
QuintilesIMS
Queensland Health

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