Colistimethate
Colistimethate for Injection, USP
Approved
Approval ID
ab241809-0d2f-44ba-829c-26be67ee623f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2020
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
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 Code63323-393
Application NumberANDA065364
Product Classification
M
Marketing Category
C73584
G
Generic Name
COLISTIMETHATE SODIUM
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 23, 2020
FDA Product Classification
INGREDIENTS (1)
COLISTIMETHATE SODIUMActive
Quantity: 150 mg in 2 mL
Code: XW0E5YS77G
Classification: ACTIR