APPLICATION
NDA050324
TYPE
NDA
ORIGINAL APPROVAL
1969-09-15
LATEST ACTION
1996-04-16
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
NEODECADRONDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 0.05% PHOSPHATE, NEOMYCIN SULFATE EQ 3.5MG BASE/GM · OINTMENT · OPHTHALMIC
Approval history
1996-04-16Manufacturing (CMC) · Supplement 32AP
1995-11-20Labeling · Supplement 11AP
1995-11-20Labeling · Supplement 8AP
1995-11-20Labeling · Supplement 12AP
1995-11-20Labeling · Supplement 9AP
1995-06-12Manufacturing (CMC) · Supplement 31AP
1992-03-11Manufacturing (CMC) · Supplement 10AP
1987-12-15Manufacturing (CMC) · Supplement 7AP
1984-09-06Manufacturing (CMC) · Supplement 4AP
1984-09-06Manufacturing (CMC) · Supplement 30AP
1984-07-10Labeling · Supplement 3AP
1984-02-28Manufacturing (CMC) · Supplement 1AP
1982-07-20Labeling · Supplement 29AP
1981-10-13Labeling · Supplement 28AP
1981-09-29Manufacturing (CMC) · Supplement 27AP
1981-09-29Manufacturing (CMC) · Supplement 25AP
1981-01-13Labeling · Supplement 24AP
1980-08-28Labeling · Supplement 23AP
1980-04-01Manufacturing (CMC) · Supplement 22AP
1978-02-17Manufacturing (CMC) · Supplement 21AP
1978-01-27Efficacy · Supplement 20AP
1977-03-23Labeling · Supplement 19AP
1976-02-23Manufacturing (CMC) · Supplement 18AP
1976-01-09Efficacy · Supplement 17AP
1975-03-07Manufacturing (CMC) · Supplement 16AP
1973-12-18Labeling · Supplement 15AP
1972-09-07Labeling · Supplement 14AP
1972-08-31Manufacturing (CMC) · Supplement 13AP
1970-04-30Labeling · Supplement 6AP
1969-12-24Manufacturing (CMC) · Supplement 5AP
1969-11-03Labeling · Supplement 2AP
1969-09-15OriginalAP
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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