APPLICATION
NDA011977
TYPE
NDA
ORIGINAL APPROVAL
1959-09-02
LATEST ACTION
1996-04-16
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
DECADRONDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 0.05% PHOSPHATE · OINTMENT · OPHTHALMIC
Approval history
1996-04-16Manufacturing (CMC) · Supplement 29 · standardAP
1995-07-10Manufacturing (CMC) · Supplement 28 · standardAP
1994-11-30Manufacturing (CMC) · Supplement 27 · standardAP
1994-10-21Labeling · Supplement 26 · standardAP
1992-05-26Labeling · Supplement 22 · standardAP
1990-12-28Manufacturing (CMC) · Supplement 24 · standardAP
1990-01-25Manufacturing (CMC) · Supplement 23 · standardAP
1989-05-30Manufacturing (CMC) · Supplement 20 · standardAP
1987-12-07Labeling · Supplement 21 · standardAP
1986-05-29Labeling · Supplement 15 · standardAP
1985-02-15Manufacturing (CMC) · Supplement 19 · standardAP
1985-02-15Manufacturing (CMC) · Supplement 18 · standardAP
1984-05-31Manufacturing (CMC) · Supplement 17 · standardAP
1982-09-15Labeling · Supplement 16 · standardAP
1981-10-21Manufacturing (CMC) · Supplement 13 · standardAP
1981-06-24Manufacturing (CMC) · Supplement 14 · standardAP
1980-12-10Labeling · Supplement 12 · standardAP
1976-05-19Labeling · Supplement 11 · standardAP
1959-09-02Type 3 - New Dosage Form · 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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