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Serving hundreds of leading biopharmaceutical companies globally:

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Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074735

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NDA 074735 describes CISPLATIN, which is a drug marketed by Accord Hlthcare, Bedford, Fresenius Kabi Usa, Gland Pharma Ltd, Hq Spclt Pharma, Mylan Labs Ltd, Pharmachemie Bv, Teva Pharms Usa, and West-ward Pharms Int, and is included in nine NDAs. It is available from ten suppliers. Additional details are available on the CISPLATIN profile page.

The generic ingredient in CISPLATIN is cisplatin. There are fourteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cisplatin profile page.
Summary for 074735
Applicant:Fresenius Kabi Usa
Formulation / Manufacturing:see details
Pharmacology for NDA: 074735
Medical Subject Heading (MeSH) Categories for 074735
Suppliers and Packaging for NDA: 074735
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CISPLATIN cisplatin INJECTABLE;INJECTION 074735 ANDA Fresenius Kabi USA, LLC 63323-103 N 63323-103-51
CISPLATIN cisplatin INJECTABLE;INJECTION 074735 ANDA Fresenius Kabi USA, LLC 63323-103 N 63323-103-64

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Jul 16, 1999TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Harvard Business School

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