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FDA Approval

Triple Antibiotic

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

FDA Approval Summary

Company
Phoenix Pharmaceutical, Inc.
DUNS: 150711039
Effective Date
November 4, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Polymyxin B(10000 [USP'U] in 1 g)
Neomycin(3.5 mg in 1 g)
Bacitracin(400 [USP'U] in 1 g)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Bausch & Lomb Incorporated

196603781

Manufacturing Establishments1

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

Bausch & Lomb Incorporated

Phoenix Pharmaceutical, Inc.

Bausch & Lomb Incorporated

807927397

Products1

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

Triple Antibiotic

Product Details

NDC Product Code
57319-343
Application Number
ANDA064064
Marketing Category
ANDA (C73584)
Route of Administration
OPHTHALMIC
Effective Date
September 30, 2010
Polymyxin BActive
Code: 19371312D4Class: ACTIBQuantity: 10000 [USP'U] in 1 g
NeomycinActive
Code: 057Y626693Class: ACTIBQuantity: 3.5 mg in 1 g
BacitracinActive
Code: 89Y4M234ESClass: ACTIBQuantity: 400 [USP'U] in 1 g
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
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