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FDA ANDA · ANDA060764

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC

Sponsor: PADAGIS US

APPLICATION
ANDA060764
TYPE
ANDA
ORIGINAL APPROVAL
1981-01-22
LATEST ACTION
2022-02-01
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINCDiscontinued
BACITRACIN ZINC 400 UNITS/GM, NEOMYCIN SULFATE EQ 3.5MG BASE/GM, POLYMYXIN B SULFATE 10,000 UNITS/GM · OINTMENT · OPHTHALMIC

Approval history

2022-02-01Labeling · Supplement 19 · standardAP
2014-08-18Manufacturing (CMC) · Supplement 16AP
2001-10-30Manufacturing (CMC) · Supplement 12AP
1996-03-07Manufacturing (CMC) · Supplement 11AP
1995-10-27Manufacturing (CMC) · Supplement 10AP
1995-06-12Manufacturing (CMC) · Supplement 7AP
1995-06-12Manufacturing (CMC) · Supplement 8AP
1995-05-19Manufacturing (CMC) · Supplement 9AP
1994-01-05Labeling · Supplement 6AP
1989-03-17Manufacturing (CMC) · Supplement 4AP
1981-01-22OriginalAP
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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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