APPLICATION
ANDA083342
TYPE
ANDA
ORIGINAL APPROVAL
1973-10-23
LATEST ACTION
1999-03-23
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
MAXIDEXDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 0.05% PHOSPHATE · OINTMENT · OPHTHALMIC
Approval history
1999-03-23Manufacturing (CMC) · Supplement 14AP
1993-09-27Labeling · Supplement 13AP
1993-02-03Manufacturing (CMC) · Supplement 11AP
1992-06-05Manufacturing (CMC) · Supplement 12AP
1991-09-25Manufacturing (CMC) · Supplement 10AP
1990-02-23Manufacturing (CMC) · Supplement 9AP
1989-09-21Labeling · Supplement 8AP
1984-06-19Manufacturing (CMC) · Supplement 5AP
1984-04-12Manufacturing (CMC) · Supplement 6AP
1973-10-23OriginalAP
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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