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FDA Approval

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate

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

FDA Approval Summary

Company
Physicians Total Care, Inc.
DUNS: 194123980
Effective Date
May 11, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Neomycin(3.5 mg in 1 g)
Polymyxin B(10000 [USP'U] in 1 g)
Bacitracin(400 [USP'U] in 1 g)
Hydrocortisone acetate(10 mg in 1 g)

Manufacturing Establishments1

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

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

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 with Hydrocortisone Acetate

Product Details

NDC Product Code
54868-6122
Application Number
ANDA062166
Marketing Category
ANDA (C73584)
Route of Administration
OPHTHALMIC
Effective Date
May 17, 2010
ZINC CHLORIDEInactive
Code: 86Q357L16BClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
NeomycinActive
Code: 057Y626693Class: ACTIBQuantity: 3.5 mg in 1 g
Polymyxin BActive
Code: 19371312D4Class: ACTIBQuantity: 10000 [USP'U] in 1 g
BacitracinActive
Code: 89Y4M234ESClass: ACTIBQuantity: 400 [USP'U] in 1 g
Hydrocortisone acetateActive
Code: 3X7931PO74Class: ACTIBQuantity: 10 mg in 1 g
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
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