BACITRACIN ZINC AND POLYMYXIN B SULFATE
BACITRACIN ZINC AND POLYMYXIN B SULFATE ointment [Akorn, Inc.]
Approved
Approval ID
628745db-880e-4663-b064-933f16c47f5c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 26, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BACITRACIN ZINC AND POLYMYXIN B SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-989
Application NumberANDA064028
Product Classification
M
Marketing Category
C73584
G
Generic Name
BACITRACIN ZINC AND POLYMYXIN B SULFATE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 26, 2011
FDA Product Classification
INGREDIENTS (4)
BACITRACIN ZINCActive
Quantity: 500 [USP'U] in 1 g
Code: 89Y4M234ES
Classification: ACTIB
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT