APPLICATION
ANDA089068
TYPE
ANDA
ORIGINAL APPROVAL
1987-05-05
LATEST ACTION
1999-02-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
SULFACETAMIDE SODIUMDiscontinued
SULFACETAMIDE SODIUM 30% · SOLUTION/DROPS · OPHTHALMIC
Approval history
1999-02-19Manufacturing (CMC) · Supplement 13AP
1999-02-02Manufacturing (CMC) · Supplement 11AP
1996-12-04Manufacturing (CMC) · Supplement 10AP
1996-04-16Manufacturing (CMC) · Supplement 9AP
1995-05-08Manufacturing (CMC) · Supplement 8AP
1993-05-17Manufacturing (CMC) · Supplement 5AP
1989-03-27Labeling · Supplement 3AP
1988-10-28Manufacturing (CMC) · Supplement 1AP
1988-10-28Manufacturing (CMC) · Supplement 2AP
1987-05-05OriginalAP
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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