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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 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. Eight suppliers are listed for this compound. Additional details are available on the colistimethate sodium profile page.

Summary for NDA: 205356

Xellia Pharms Aps
colistimethate sodium

Suppliers and Packaging for NDA: 205356

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
colistimethate sodium
INJECTABLE;INJECTION 205356 ANDA X-GEN Pharmaceuticals, Inc. 39822-0617 39822-0617-1 1 VIAL in 1 CARTON (39822-0617-1) > 2 mL in 1 VIAL
colistimethate sodium
INJECTABLE;INJECTION 205356 ANDA X-GEN Pharmaceuticals, Inc. 39822-0617 39822-0617-2 12 VIAL in 1 CARTON (39822-0617-2) > 2 mL in 1 VIAL

Summary 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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