APPLICATION
ANDA080029
TYPE
ANDA
ORIGINAL APPROVAL
1971-12-22
LATEST ACTION
1996-03-07
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
SULFACETAMIDE SODIUMDiscontinued
SULFACETAMIDE SODIUM 10% · OINTMENT · OPHTHALMIC
Approval history
1996-03-07Manufacturing (CMC) · Supplement 37AP
1995-10-27Manufacturing (CMC) · Supplement 35AP
1995-10-27Manufacturing (CMC) · Supplement 36AP
1995-08-03Manufacturing (CMC) · Supplement 33AP
1995-08-03Manufacturing (CMC) · Supplement 34AP
1995-03-13Manufacturing (CMC) · Supplement 31AP
1995-01-19Labeling · Supplement 32AP
1993-09-14Labeling · Supplement 30AP
1991-05-02Manufacturing (CMC) · Supplement 29AP
1989-05-19Labeling · Supplement 27AP
1988-03-25Labeling · Supplement 26AP
1983-08-01Manufacturing (CMC) · Supplement 25AP
1982-07-08Manufacturing (CMC) · Supplement 20AP
1971-12-22OriginalAP
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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