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Details for New Drug Application (NDA): 200144

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NDA 200144 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 three 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. Five suppliers are listed for this compound. Additional details are available on the idarubicin hydrochloride profile page.

Summary for NDA: 200144

Tradename:
IDARUBICIN HYDROCHLORIDE
Applicant:
Mylan Labs Ltd
Ingredient:
idarubicin hydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 200144

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors

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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