COLISTIMETHATE SODIUM
Colistimethate for Injection, USP
Approved
Approval ID
6a335659-03b0-4a2d-9cd4-7dcf7da96fe6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2023
Manufacturers
FDA
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
DUNS: 780779901
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 Code23155-193
Application NumberANDA202359
Product Classification
M
Marketing Category
C73584
G
Generic Name
COLISTIMETHATE SODIUM
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJuly 5, 2022
FDA Product Classification
INGREDIENTS (2)
COLISTIMETHATE SODIUMActive
Quantity: 150 mg in 4 mL
Code: XW0E5YS77G
Classification: ACTIR
WATERInactive
Code: 059QF0KO0R
Classification: IACT