POLYMYXIN B
Approved
Approval ID
fbc12c18-567b-41bc-89d0-efd29616615c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2021
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.
POLYMYXIN B SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-321
Application NumberANDA065372
Product Classification
M
Marketing Category
C73584
G
Generic Name
POLYMYXIN B SULFATE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, INTRATHECAL, OPHTHALMIC
Effective DateFebruary 28, 2021
FDA Product Classification
INGREDIENTS (1)
POLYMYXIN B SULFATEActive
Quantity: 500000 [USP'U] in 1 1
Code: 19371312D4
Classification: ACTIM