Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson

Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201365

« Back to Dashboard

NDA 201365 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 201365
Applicant:Sagent Pharms
Ingredient:colistimethate sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 201365
Suppliers and Packaging for NDA: 201365
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 201365 ANDA Sagent Pharmaceuticals 25021-159 N 25021-159-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 150MG BASE/VIAL
Approval Date:Feb 19, 2014TE:APRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Argus Health
US Department of Justice

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.