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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 064216


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NDA 064216 describes COLISTIMETHATE SODIUM, which is a drug marketed by Avet Lifesciences, Fresenius Kabi Usa, Nexus, Sagent Pharms Inc, Xellia Pharms Aps, and Xgen Pharms, and is included in six NDAs. It is available from five 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. Six suppliers are listed for this compound. Additional details are available on the colistimethate sodium profile page.
Summary for 064216
Tradename:COLISTIMETHATE SODIUM
Applicant:Xgen Pharms
Ingredient:colistimethate sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 064216
Suppliers and Packaging for NDA: 064216
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 064216 ANDA XGen Pharmaceuticals DJB, Inc. 39822-0615 39822-0615-2 12 CARTON in 1 CARTON (39822-0615-2) / 1 VIAL in 1 CARTON (39822-0615-1) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 150MG BASE/VIAL
Approval Date:Feb 26, 1999TE:APRLD:No

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