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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091293

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NDA 091293 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 091293

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

Pharmacology for NDA: 091293

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for 091293

Suppliers and Packaging for NDA: 091293

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IDARUBICIN HYDROCHLORIDE idarubicin hydrochloride INJECTABLE;INJECTION 091293 ANDA Sandoz Inc 66758-055 66758-055-03 10 mL in 1 VIAL, SINGLE-USE (66758-055-03)
IDARUBICIN HYDROCHLORIDE idarubicin hydrochloride INJECTABLE;INJECTION 091293 ANDA Sandoz Inc 66758-055 66758-055-01 5 mL in 1 VIAL, SINGLE-USE (66758-055-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Mar 29, 2011TE:RLD:No


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