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FDA ANDA · ANDA062166

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE

Sponsor: PADAGIS US

APPLICATION
ANDA062166
TYPE
ANDA
ORIGINAL APPROVAL
1981-04-14
LATEST ACTION
2001-09-12
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATEDiscontinued
BACITRACIN ZINC 400 UNITS/GM, HYDROCORTISONE ACETATE 1%, NEOMYCIN SULFATE EQ 3.5MG BASE/GM, POLYMYXIN B SULFATE 10,000 UNITS/GM · OINTMENT · OPHTHALMIC

Approval history

2001-09-12Manufacturing (CMC) · Supplement 16AP
1996-03-07Manufacturing (CMC) · Supplement 15AP
1995-10-27Manufacturing (CMC) · Supplement 13AP
1995-10-27Manufacturing (CMC) · Supplement 14AP
1995-07-14Manufacturing (CMC) · Supplement 11AP
1995-07-14Manufacturing (CMC) · Supplement 12AP
1994-12-09Manufacturing (CMC) · Supplement 9AP
1993-12-07Labeling · Supplement 10AP
1992-05-18Manufacturing (CMC) · Supplement 8AP
1989-03-17Manufacturing (CMC) · Supplement 7AP
1988-11-17Manufacturing (CMC) · Supplement 6AP
1981-04-14OriginalAP
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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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