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Generated: May 25, 2019

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Details for New Drug Application (NDA): 050108

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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
Patents:0
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 42023-107-01 1 VIAL in 1 CARTON (42023-107-01) > 2 mL in 1 VIAL
COLY-MYCIN M colistimethate sodium INJECTABLE;INJECTION 050108 NDA Par Pharmaceutical, Inc. 42023-107 42023-107-06 6 VIAL in 1 CARTON (42023-107-06) > 2 mL in 1 VIAL

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

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