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Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075259

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NDA 075259 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 075259
Applicant:Teva Pharms Usa
Formulation / Manufacturing:see details
Pharmacology for NDA: 075259
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 075259
Suppliers and Packaging for NDA: 075259
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DACARBAZINE dacarbazine INJECTABLE;INJECTION 075259 ANDA Teva Parenteral Medicines, Inc. 0703-5075 N 0703-5075-01
DACARBAZINE dacarbazine INJECTABLE;INJECTION 075259 ANDA Teva Parenteral Medicines, Inc. 0703-5075 N 0703-5075-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Sep 22, 2000TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/VIAL
Approval Date:Aug 27, 1998TE:APRLD:No

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