APPLICATION
ANDA087771
TYPE
ANDA
ORIGINAL APPROVAL
1993-08-06
LATEST ACTION
2000-01-18
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
CETAPREDDiscontinued
PREDNISOLONE ACETATE 0.25%, SULFACETAMIDE SODIUM 10% · OINTMENT · OPHTHALMIC
Approval history
2000-01-18Manufacturing (CMC) · Supplement 7AP
1999-03-23Manufacturing (CMC) · Supplement 6AP
1996-12-12Manufacturing (CMC) · Supplement 4AP
1996-04-18Manufacturing (CMC) · Supplement 3AP
1996-04-18Manufacturing (CMC) · Supplement 2AP
1995-06-28Manufacturing (CMC) · Supplement 1AP
1993-08-06OriginalAP
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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