APPLICATION
ANDA088791
TYPE
ANDA
ORIGINAL APPROVAL
1984-10-05
LATEST ACTION
1997-12-05
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
VASOCIDINDiscontinued
PREDNISOLONE ACETATE 0.5%, SULFACETAMIDE SODIUM 10% · OINTMENT · OPHTHALMIC
Approval history
1997-12-05Manufacturing (CMC) · Supplement 11AP
1996-08-13Manufacturing (CMC) · Supplement 13AP
1996-07-03Manufacturing (CMC) · Supplement 12AP
1995-12-15Manufacturing (CMC) · Supplement 10AP
1994-05-06Labeling · Supplement 9AP
1993-01-29Labeling · Supplement 8AP
1991-12-09Labeling · Supplement 6AP
1991-02-15Manufacturing (CMC) · Supplement 7AP
1985-09-17Manufacturing (CMC) · Supplement 4AP
1984-10-05OriginalAP
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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