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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
Daiichi Sankyo
Cantor Fitzgerald
Fish and Richardson
Argus Health

Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064216

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NDA 064216 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. Seven suppliers are listed for this compound. Additional details are available on the colistimethate sodium profile page.

Summary for NDA: 064216

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
INJECTABLE;INJECTION 064216 ANDA X-GEN Pharmaceuticals, 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

Summary 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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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Queensland Health
Federal Trade Commission
Harvard Business School

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