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Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065275

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NDA 065275 describes IDARUBICIN HYDROCHLORIDE, which is a drug marketed by Teva Parenteral, Fresenius Kabi Usa, Mylan Labs Ltd, West-ward Pharms Int, Sandoz, and Teva Pharms Usa, and is included in seven NDAs. It is available from four suppliers. Additional details are available on the IDARUBICIN HYDROCHLORIDE profile page.

The generic ingredient in IDARUBICIN HYDROCHLORIDE is idarubicin hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the idarubicin hydrochloride profile page.

Summary for NDA: 065275

Formulation / Manufacturing:see details

Pharmacology for NDA: 065275

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 065275

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
idarubicin hydrochloride
INJECTABLE;INJECTION 065275 ANDA West-Ward Pharmaceuticals Corp 0143-9217 0143-9217-01 1 VIAL, GLASS in 1 BOX (0143-9217-01) > 5 mL in 1 VIAL, GLASS
idarubicin hydrochloride
INJECTABLE;INJECTION 065275 ANDA West-Ward Pharmaceuticals Corp 0143-9218 0143-9218-01 1 VIAL, GLASS in 1 BOX (0143-9218-01) > 10 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Dec 14, 2006TE:APRLD:No

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Serving 500+ biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
Chinese Patent Office
US Army
Express Scripts

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