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Last Updated: August 9, 2020

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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, Nexus Pharms, Sagent Pharms Inc, Xellia Pharms Aps, and Xgen Pharms, 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:COLISTIMETHATE SODIUM
Applicant:Fresenius Kabi Usa
Ingredient:colistimethate sodium
Patents:0
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 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

Profile 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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