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Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202359

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NDA 202359 describes COLISTIMETHATE SODIUM, which is a drug marketed by Emcure Pharms Ltd, Fresenius Kabi Usa, Paddock Llc, Sagent Pharms, X Gen Pharms, and Xellia Pharms Aps, 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 202359
Applicant:Emcure Pharms Ltd
Ingredient:colistimethate sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 202359
Suppliers and Packaging for NDA: 202359
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 202359 ANDA Heritage Pharmaceuticals Inc. 23155-193 N 23155-193-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 150MG BASE/VIAL
Approval Date:Sep 28, 2012TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Chinese Patent Office

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