APPLICATION
NDA050479
TYPE
NDA
ORIGINAL APPROVAL
1975-12-09
LATEST ACTION
2025-08-08
ROUTE
OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
CORTISPORIN · ReferenceDiscontinued
HYDROCORTISONE 1%, NEOMYCIN SULFATE EQ 3.5MG BASE/ML, POLYMYXIN B SULFATE 10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OTIC
Approval history
1999-06-28Manufacturing (CMC) · Supplement 16 · standardAP
1999-03-15Manufacturing (CMC) · Supplement 14 · standardAP
1996-11-21Labeling · Supplement 12AP
1987-11-19Labeling · Supplement 6AP
1987-04-01Labeling · Supplement 5AP
1986-08-08Labeling · Supplement 4AP
1985-12-13Labeling · Supplement 3AP
1984-08-20Labeling · Supplement 2AP
1983-07-06Labeling · Supplement 1AP
1980-01-04Labeling · Supplement 11AP
1979-10-09Labeling · Supplement 10AP
1976-10-18Labeling · Supplement 9AP
1976-06-22Labeling · Supplement 8AP
1976-01-29Labeling · Supplement 7AP
1975-12-09Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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