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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065177

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NDA 065177 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 065177
Tradename:COLISTIMETHATE SODIUM
Applicant:Paddock Llc
Ingredient:colistimethate sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065177
Ingredient-typePolymyxins
Suppliers and Packaging for NDA: 065177
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 065177 ANDA Paddock Laboratories, LLC 0574-0858 N 0574-0858-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 150MG BASE/VIAL
Approval Date:Mar 19, 2004TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
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Teva
Chinese Patent Office
Dow
Covington
Deloitte
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Cipla

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