POLYMYXIN B
Polymyxin B for Injection, USP 50,000 Units Rx Only To reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin B and other antibacterial drugs, polymyxin B should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Approved
Approval ID
fd664927-db58-a1af-e053-6294a90a9048
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 5, 2023
Manufacturers
FDA
FOSUN PHARMA USA INC
DUNS: 080920998
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 Code72266-249
Application NumberANDA207322
Product Classification
M
Marketing Category
C73584
G
Generic Name
POLYMYXIN B SULFATE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, INTRATHECAL, OPHTHALMIC
Effective DateJune 5, 2023
FDA Product Classification
INGREDIENTS (1)
POLYMYXIN B SULFATEActive
Quantity: 500000 [USP'U] in 1 1
Code: 19371312D4
Classification: ACTIM