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FDA Approval

Bacitracin Zinc and Polymyxin B Sulfate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
July 24, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Bacitracin(500 [USP'U] in 1 g)
Polymyxin B(10000 [USP'U] in 1 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

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

NDC Product Code
50090-3274
Application Number
ANDA064046
Marketing Category
ANDA (C73584)
Route of Administration
OPHTHALMIC
Effective Date
January 31, 2023
Code: 89Y4M234ESClass: ACTIMQuantity: 500 [USP'U] in 1 g
Code: 19371312D4Class: ACTIMQuantity: 10000 [USP'U] in 1 g
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
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