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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
Mallinckrodt
Novartis
Baxter
QuintilesIMS
Moodys
Merck
Dow
Cantor Fitzgerald

Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200144

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NDA 200144 describes IDARUBICIN HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Mylan Labs Ltd, Sandoz, Teva Parenteral, West-ward Pharms Int, 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 200144

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 200144

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for 200144

Suppliers and Packaging for NDA: 200144

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IDARUBICIN HYDROCHLORIDE idarubicin hydrochloride INJECTABLE;INJECTION 200144 ANDA Amneal-Agila, LLC 53150-336 53150-336-01 1 VIAL, SINGLE-DOSE in 1 CARTON (53150-336-01) > 5 mL in 1 VIAL, SINGLE-DOSE
IDARUBICIN HYDROCHLORIDE idarubicin hydrochloride INJECTABLE;INJECTION 200144 ANDA Amneal-Agila, LLC 53150-386 53150-386-01 1 VIAL, SINGLE-DOSE in 1 CARTON (53150-386-01) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Oct 11, 2012TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Julphar
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Merck
Harvard Business School
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US Department of Justice
Queensland Health
Fish and Richardson

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