APPLICATION
NDA050169
TYPE
NDA
ORIGINAL APPROVAL
1964-12-18
LATEST ACTION
2003-11-25
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Discontinued
Products
CORTISPORINDiscontinued
HYDROCORTISONE 1%, NEOMYCIN SULFATE EQ 3.5MG BASE/ML, POLYMYXIN B SULFATE 10,000 UNITS/ML · SUSPENSION/DROPS · OPHTHALMIC
Approval history
1999-04-19Manufacturing (CMC) · Supplement 45AP
1995-06-13Manufacturing (CMC) · Supplement 44AP
1994-05-10Labeling · Supplement 9AP
1985-12-13Manufacturing (CMC) · Supplement 8AP
1984-08-21Manufacturing (CMC) · Supplement 7AP
1984-02-28Manufacturing (CMC) · Supplement 6AP
1983-03-30Labeling · Supplement 1AP
1982-09-13Manufacturing (CMC) · Supplement 42AP
1982-03-26Manufacturing (CMC) · Supplement 41AP
1982-01-26Manufacturing (CMC) · Supplement 40AP
1981-10-20Manufacturing (CMC) · Supplement 37AP
1981-09-15Manufacturing (CMC) · Supplement 36AP
1981-01-16Efficacy · Supplement 34AP
1980-12-01Labeling · Supplement 35AP
1972-11-20Labeling · Supplement 31AP
1972-07-06Labeling · Supplement 30AP
1972-06-21Labeling · Supplement 28AP
1971-05-11Manufacturing (CMC) · Supplement 25AP
1970-12-18Labeling · Supplement 24AP
1970-10-09Labeling · Supplement 23AP
1970-07-27Labeling · Supplement 22AP
1969-03-25Manufacturing (CMC) · Supplement 19AP
1969-03-24Manufacturing (CMC) · Supplement 17AP
1969-03-17Manufacturing (CMC) · Supplement 20AP
1967-07-13Labeling · Supplement 16AP
1967-04-20Labeling · Supplement 15AP
1967-04-10Labeling · Supplement 14AP
1967-04-04Labeling · Supplement 13AP
1966-10-19Labeling · Supplement 12AP
1966-09-13Labeling · Supplement 10AP
1966-05-05Labeling · Supplement 3AP
1965-09-30Labeling · Supplement 2AP
1964-12-18UNKNOWN · Original · unknownAP
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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