APPLICATION
NDA050368
TYPE
NDA
ORIGINAL APPROVAL
1964-06-29
LATEST ACTION
1993-07-14
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
ILOTYCINDiscontinued
ERYTHROMYCIN 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · OPHTHALMIC
Approval history
1993-07-14Labeling · Supplement 10AP
1993-07-14Labeling · Supplement 9AP
1988-07-13Manufacturing (CMC) · Supplement 41AP
1987-05-22Labeling · Supplement 8AP
1986-04-15Manufacturing (CMC) · Supplement 6AP
1986-03-10Labeling · Supplement 5AP
1985-03-27Manufacturing (CMC) · Supplement 3AP
1984-03-06Manufacturing (CMC) · Supplement 2AP
1982-12-28Manufacturing (CMC) · Supplement 1AP
1982-06-28Manufacturing (CMC) · Supplement 40AP
1981-12-23Manufacturing (CMC) · Supplement 39AP
1981-03-24Labeling · Supplement 37AP
1981-02-11Manufacturing (CMC) · Supplement 38AP
1981-01-22Labeling · Supplement 36AP
1980-10-21Labeling · Supplement 35AP
1980-02-06Manufacturing (CMC) · Supplement 34AP
1980-01-31Manufacturing (CMC) · Supplement 33AP
1979-02-14Manufacturing (CMC) · Supplement 32AP
1978-03-06Manufacturing (CMC) · Supplement 31AP
1977-01-21Manufacturing (CMC) · Supplement 30AP
1976-03-26Labeling · Supplement 28AP
1976-03-26Labeling · Supplement 29AP
1976-01-29Manufacturing (CMC) · Supplement 27AP
1975-09-09Labeling · Supplement 26AP
1975-01-28Manufacturing (CMC) · Supplement 25AP
1974-07-23Labeling · Supplement 24AP
1973-11-12Manufacturing (CMC) · Supplement 23AP
1973-02-16Manufacturing (CMC) · Supplement 22AP
1972-11-22Manufacturing (CMC) · Supplement 21AP
1972-11-03Labeling · Supplement 19AP
1972-10-31Labeling · Supplement 20AP
1971-12-01Manufacturing (CMC) · Supplement 18AP
1970-12-15Manufacturing (CMC) · Supplement 17AP
1969-12-15Manufacturing (CMC) · Supplement 16AP
1969-05-09Labeling · Supplement 15AP
1969-04-28Manufacturing (CMC) · Supplement 14AP
1969-02-11Manufacturing (CMC) · Supplement 13AP
1969-01-16Manufacturing (CMC) · Supplement 12AP
1967-05-17Labeling · Supplement 11AP
1967-05-03Efficacy · Supplement 7AP
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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