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FDA ANDA · ANDA064028

BACITRACIN ZINC AND POLYMYXIN B SULFATE

Sponsor: SCIEGEN PHARMS

APPLICATION
ANDA064028
TYPE
ANDA
ORIGINAL APPROVAL
1995-01-30
LATEST ACTION
2017-03-10
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

2017-03-10Manufacturing (CMC) · Supplement 7 · unknownAP
1996-08-27Manufacturing (CMC) · Supplement 2AP
1996-01-17Manufacturing (CMC) · Supplement 1AP
1995-01-30OriginalAP
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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