Coly-Mycin
Coly-Mycin® M Parenteral (Colistimethate for Injection, USP)
Approved
Approval ID
6d6e13e2-dc33-4b7b-84d0-66146a57c552
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 3, 2018
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
colistimethate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42023-107
Application NumberNDA050108
Product Classification
M
Marketing Category
C73594
G
Generic Name
colistimethate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 10, 2021
FDA Product Classification
INGREDIENTS (1)
COLISTIMETHATE SODIUMActive
Quantity: 150 mg in 2 mL
Code: XW0E5YS77G
Classification: ACTIR