Bacitracin Zinc and Polymyxin B Sulfate
BACITRACIN ZINC AND POLYMYXIN B SULFATE OPHTHALMIC OINTMENT, USP
Approved
Approval ID
58f12018-ef71-4a2b-a6f5-6ec3ac19c353
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 8, 2009
Manufacturers
FDA
E. FOUGERA & CO., A division of Nycomed US Inc.
DUNS: 043838424
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 Code0168-0273
Application NumberANDA065022
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bacitracin Zinc and Polymyxin B Sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 28, 2009
FDA Product Classification
INGREDIENTS (4)
polymyxin B sulfateActive
Quantity: 10000 1 in 1 g
Code: 19371312D4
Classification: ACTIB
Bacitracin ZincActive
Quantity: 500 1 in 1 g
Code: 89Y4M234ES
Classification: ACTIB
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT