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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
Direct_Rx
DUNS: 079254320
Effective Date
July 24, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Bacitracin(500 [USP'U] in 1 g)
Polymyxin B(10000 [USP'U] in 1 g)

Registrants1

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

Direct_Rx

079254320

Manufacturing Establishments1

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

Direct_Rx

Direct_Rx

Direct_Rx

079254320

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
72189-017
Application Number
ANDA064046
Marketing Category
ANDA (C73584)
Route of Administration
OPHTHALMIC
Effective Date
July 24, 2019
Code: 89Y4M234ESClass: ACTIMQuantity: 500 [USP'U] in 1 g
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
Code: 19371312D4Class: ACTIMQuantity: 10000 [USP'U] in 1 g
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