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FDA NDA · NDA050416

CORTISPORIN

Sponsor: CASPER PHARMA LLC

APPLICATION
NDA050416
TYPE
NDA
ORIGINAL APPROVAL
1971-05-10
LATEST ACTION
2004-03-22
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

CORTISPORIN · ReferenceDiscontinued
BACITRACIN ZINC 400 UNITS/GM, HYDROCORTISONE 1%, NEOMYCIN SULFATE EQ 3.5MG BASE/GM, POLYMYXIN B SULFATE 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · OPHTHALMIC

Approval history

2004-03-22Labeling · Supplement 15 · standard — Label ↗AP
1999-04-19Manufacturing (CMC) · Supplement 14AP
1998-06-23Manufacturing (CMC) · Supplement 13AP
1995-06-13Manufacturing (CMC) · Supplement 12AP
1995-02-09Manufacturing (CMC) · Supplement 11AP
1994-12-22Manufacturing (CMC) · Supplement 10AP
1994-05-10Labeling · Supplement 6AP
1993-09-22Manufacturing (CMC) · Supplement 9AP
1993-03-23Manufacturing (CMC) · Supplement 8AP
1992-08-10Manufacturing (CMC) · Supplement 7AP
1971-05-10UNKNOWN · Original · unknownAP
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