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Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065364

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NDA 065364 describes COLISTIMETHATE SODIUM, which is a drug marketed by X Gen Pharms, Xellia Pharms Aps, Emcure Pharms Ltd, Fresenius Kabi Usa, Sagent Pharms, and Paddock Llc, and is included in six NDAs. It is available from six suppliers. Additional details are available on the COLISTIMETHATE SODIUM profile page.

The generic ingredient in COLISTIMETHATE SODIUM is colistimethate sodium. There are two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the colistimethate sodium profile page.

Summary for NDA: 065364

Formulation / Manufacturing:see details

Pharmacology for NDA: 065364


Suppliers and Packaging for NDA: 065364

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
colistimethate sodium
INJECTABLE;INJECTION 065364 ANDA Fresenius Kabi USA, LLC 63323-393 63323-393-06 1 VIAL in 1 BOX (63323-393-06) > 2 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 150MG BASE/VIAL
Approval Date:Apr 17, 2008TE:APRLD:No

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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
US Army
Federal Trade Commission
Queensland Health
Johnson and Johnson
Chinese Patent Office

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