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FDA ANDA · ANDA065022

BACITRACIN ZINC AND POLYMYXIN B SULFATE

Sponsor: PADAGIS US

APPLICATION
ANDA065022
TYPE
ANDA
ORIGINAL APPROVAL
2002-02-27
LATEST ACTION
2014-08-15
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

BACITRACIN ZINC AND POLYMYXIN B SULFATEDiscontinued
BACITRACIN ZINC 500 UNITS/GM, POLYMYXIN B SULFATE 10,000 UNITS/GM · OINTMENT · OPHTHALMIC

Approval history

2014-08-15Manufacturing (CMC) · Supplement 4AP
2002-02-27OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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