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Last Updated: August 9, 2020

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Details for New Drug Application (NDA): 205356

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NDA 205356 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 205356
Tradename:COLISTIMETHATE SODIUM
Applicant:Xellia Pharms Aps
Ingredient:colistimethate sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205356
Suppliers and Packaging for NDA: 205356
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 205356 ANDA Xellia Pharmaceuticals ApS 45932-0023 45932-0023-1 1 VIAL in 1 CARTON (45932-0023-1) > 2 mL in 1 VIAL
COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 205356 ANDA Xellia Pharmaceuticals ApS 45932-0023 45932-0023-2 6 VIAL in 1 CARTON (45932-0023-2) > 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 150MG BASE/VIAL
Approval Date:May 29, 2015TE:APRLD:No

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