APPLICATION
ANDA080020
TYPE
ANDA
ORIGINAL APPROVAL
1971-05-05
LATEST ACTION
2002-12-23
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
ISOPTO CETAMIDEDiscontinued
SULFACETAMIDE SODIUM 15% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2002-12-23Manufacturing (CMC) · Supplement 31AP
2000-04-28Manufacturing (CMC) · Supplement 29AP
2000-04-07Manufacturing (CMC) · Supplement 30AP
1999-05-07Manufacturing (CMC) · Supplement 27AP
1999-03-23Manufacturing (CMC) · Supplement 28AP
1999-03-04Manufacturing (CMC) · Supplement 26AP
1998-03-27Manufacturing (CMC) · Supplement 25AP
1996-07-31Labeling · Supplement 24AP
1995-10-05Manufacturing (CMC) · Supplement 21AP
1995-08-04Manufacturing (CMC) · Supplement 20AP
1995-04-21Labeling · Supplement 19AP
1994-08-03Manufacturing (CMC) · Supplement 18AP
1993-08-03Labeling · Supplement 17AP
1993-06-04Manufacturing (CMC) · Supplement 16AP
1993-06-04Manufacturing (CMC) · Supplement 14AP
1991-07-11Labeling · Supplement 15AP
1989-09-15Labeling · Supplement 13AP
1989-04-26Manufacturing (CMC) · Supplement 12AP
1971-05-05OriginalAP
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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