APPLICATION
ANDA087547
TYPE
ANDA
ORIGINAL APPROVAL
1981-07-21
LATEST ACTION
2000-04-28
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
ISOPTO CETAPREDDiscontinued
PREDNISOLONE ACETATE 0.25%, SULFACETAMIDE SODIUM 10% · SUSPENSION · OPHTHALMIC
Approval history
2000-04-28Manufacturing (CMC) · Supplement 22AP
1999-05-07Manufacturing (CMC) · Supplement 20AP
1999-04-21Manufacturing (CMC) · Supplement 21AP
1996-04-18Manufacturing (CMC) · Supplement 17AP
1996-04-18Manufacturing (CMC) · Supplement 18AP
1995-10-05Manufacturing (CMC) · Supplement 16AP
1995-08-04Manufacturing (CMC) · Supplement 15AP
1995-06-28Manufacturing (CMC) · Supplement 13AP
1994-12-06Labeling · Supplement 14AP
1993-10-13Labeling · Supplement 12AP
1993-06-04Manufacturing (CMC) · Supplement 10AP
1993-06-04Manufacturing (CMC) · Supplement 8AP
1993-04-28Labeling · Supplement 11AP
1993-01-05Labeling · Supplement 9AP
1990-12-27Labeling · Supplement 7AP
1989-10-26Labeling · Supplement 6AP
1989-04-27Manufacturing (CMC) · Supplement 5AP
1984-12-10Manufacturing (CMC) · Supplement 1AP
1981-07-21OriginalAP
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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