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

Serving leading biopharmaceutical companies globally:

Argus Health
Johnson and Johnson

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050108

« Back to Dashboard

NDA 050108 describes COLY-MYCIN M, which is a drug marketed by Par Sterile Products and is included in one NDA. It is available from one supplier. Additional details are available on the COLY-MYCIN M profile page.

The generic ingredient in COLY-MYCIN M 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 050108
Tradename:COLY-MYCIN M
Applicant:Par Sterile Products
Ingredient:colistimethate sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 050108
Suppliers and Packaging for NDA: 050108
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COLY-MYCIN M colistimethate sodium INJECTABLE;INJECTION 050108 NDA Par Pharmaceutical, Inc. 42023-107 N 42023-107-06
COLY-MYCIN M colistimethate sodium INJECTABLE;INJECTION 050108 NDA Par Pharmaceutical, Inc. 42023-107 N 42023-107-01

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 150MG BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Cantor Fitzgerald
Express Scripts
Harvard Business School

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.