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Generated: May 27, 2017

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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 NDA: 050108

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
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
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

Summary 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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