Colistimethate Sodium
Colistimethate For Injection, USP
Approved
Approval ID
8dda0fab-a1f5-401a-a5a7-9fdccc170c73
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 11, 2022
Manufacturers
FDA
Nexus Pharmaceuticals Inc
DUNS: 620714787
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Colistimethate Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14789-201
Application NumberANDA065177
Product Classification
M
Marketing Category
C73584
G
Generic Name
Colistimethate Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateSeptember 28, 2021
FDA Product Classification
INGREDIENTS (3)
Colistimethate SodiumActive
Quantity: 150 mg in 1 1
Code: XW0E5YS77G
Classification: ACTIR
WaterInactive
Code: 059QF0KO0R
Classification: IACT
NitrogenInactive
Code: N762921K75
Classification: IACT