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FDA Approval

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc

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

FDA Approval Summary

Company
Bausch & Lomb Incorporated
DUNS: 196603781
Effective Date
June 30, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Neomycin(3.5 mg in 1 g)
Bacitracin(400 [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.

Bausch & Lomb Incorporated

Bausch & Lomb Incorporated

079587625

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc

Product Details

NDC Product Code
24208-780
Application Number
ANDA064064
Marketing Category
ANDA (C73584)
Route of Administration
OPHTHALMIC
Effective Date
June 30, 2023
NeomycinActive
Code: 057Y626693Class: ACTIMQuantity: 3.5 mg in 1 g
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
BacitracinActive
Code: 89Y4M234ESClass: ACTIMQuantity: 400 [USP'U] in 1 g
Polymyxin BActive
Code: 19371312D4Class: ACTIMQuantity: 10000 [USP'U] in 1 g
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
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