BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Daiichi Sankyo
Queensland Health

Generated: December 17, 2017

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

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 63323-127-10 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-127-10) > 10 mL in 1 VIAL, SINGLE-DOSE
DACARBAZINE dacarbazine INJECTABLE;INJECTION 075371 ANDA APP Pharmaceuticals, LLC 63323-128 63323-128-20 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-128-20) > 20 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

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

Summary for product number 002

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

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Serving leading biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office
Argus Health
Harvard Business School

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