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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050731

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NDA 050731 describes DAUNORUBICIN HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Teva Parenteral, Teva Pharms Usa, and West-ward Pharms Int, and is included in five NDAs. It is available from two suppliers. Additional details are available on the DAUNORUBICIN HYDROCHLORIDE profile page.

The generic ingredient in DAUNORUBICIN HYDROCHLORIDE is daunorubicin hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the daunorubicin hydrochloride profile page.
Summary for 050731
Tradename:DAUNORUBICIN HYDROCHLORIDE
Applicant:West-ward Pharms Int
Ingredient:daunorubicin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050731
Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors
Suppliers and Packaging for NDA: 050731
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAUNORUBICIN HYDROCHLORIDE daunorubicin hydrochloride INJECTABLE;INJECTION 050731 NDA West-Ward Pharmaceuticals Corp 0143-9550 N 0143-9550-01
DAUNORUBICIN HYDROCHLORIDE daunorubicin hydrochloride INJECTABLE;INJECTION 050731 NDA West-Ward Pharmaceuticals Corp 0143-9551 N 0143-9551-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Jan 30, 1998TE:APRLD:Yes

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Johnson and Johnson
Harvard Business School
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Federal Trade Commission
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Dow

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