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Serving leading biopharmaceutical companies globally:

Harvard Business School
Farmers Insurance
Queensland Health
Johnson and Johnson
Argus Health

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065035

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NDA 065035 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 one supplier. 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. One supplier is listed for this compound. Additional details are available on the daunorubicin hydrochloride profile page.
Summary for 065035
Applicant:Teva Pharms Usa
Ingredient:daunorubicin hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 065035
Mechanism of ActionTopoisomerase Inhibitors
Suppliers and Packaging for NDA: 065035
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAUNORUBICIN HYDROCHLORIDE daunorubicin hydrochloride INJECTABLE;INJECTION 065035 ANDA Teva Parenteral Medicines, Inc. 0703-5233 N 0703-5233-13
DAUNORUBICIN HYDROCHLORIDE daunorubicin hydrochloride INJECTABLE;INJECTION 065035 ANDA Teva Parenteral Medicines, Inc. 0703-5233 N 0703-5233-93

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Jan 24, 2000TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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Express Scripts
US Army

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