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Serving hundreds of leading biopharmaceutical companies globally:

Teva
US Army
Queensland Health
Federal Trade Commission
Moodys
Cerilliant
McKinsey
Citi
Accenture

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075371

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NDA 075371 describes DACARBAZINE, which is a drug marketed by Abraxis Pharm, Fresenius Kabi Usa, Hospira, Teva Pharms Usa, and West-ward Pharms Int, and is included in six NDAs. It is available from three suppliers. Additional details are available on the DACARBAZINE profile page.

The generic ingredient in DACARBAZINE is dacarbazine. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dacarbazine profile page.
Summary for 075371
Tradename:DACARBAZINE
Applicant:Fresenius Kabi Usa
Ingredient:dacarbazine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075371
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 075371
Suppliers and Packaging for NDA: 075371
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DACARBAZINE dacarbazine INJECTABLE;INJECTION 075371 ANDA APP Pharmaceuticals, LLC 63323-127 N 63323-127-10
DACARBAZINE dacarbazine INJECTABLE;INJECTION 075371 ANDA APP Pharmaceuticals, LLC 63323-128 N 63323-128-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/VIAL
Approval Date:Aug 27, 1999TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/VIAL
Approval Date:Aug 27, 1999TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Chinese Patent Office
Colorcon
QuintilesIMS
Mallinckrodt
Chubb
Argus Health
Federal Trade Commission
Medtronic

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