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Generated: December 14, 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 Emcure Pharms Ltd, Fresenius Kabi Usa, Paddock Llc, Sagent Pharms, X Gen Pharms, and Xellia Pharms Aps, 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 065364

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 065364

Ingredient-typePolymyxins

Suppliers and Packaging for NDA: 065364

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COLISTIMETHATE SODIUM 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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