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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Cipla
Cantor Fitzgerald
Covington
Fuji
Argus Health
Moodys
Daiichi Sankyo
Fish and Richardson

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062975

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NDA 062975 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 062975
Tradename:DOXORUBICIN HYDROCHLORIDE
Applicant:West-ward Pharms Int
Ingredient:doxorubicin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 062975
Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 062975
Suppliers and Packaging for NDA: 062975
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 062975 ANDA West-Ward Pharmaceuticals Corp 0143-9547 N 0143-9547-01
DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 062975 ANDA West-Ward Pharmaceuticals Corp 0143-9548 N 0143-9548-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Mar 17, 1989TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Covington
Mallinckrodt
Cipla
Cerilliant
AstraZeneca
Fish and Richardson
Johnson and Johnson
Baxter

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