APPLICATION
ANDA089560
TYPE
ANDA
ORIGINAL APPROVAL
1988-10-18
LATEST ACTION
2003-05-20
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
SULFACETAMIDE SODIUMPrescription
SULFACETAMIDE SODIUM 10% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2003-05-20Labeling · Supplement 19AP
2003-01-24Labeling · Supplement 18AP
1999-02-19Manufacturing (CMC) · Supplement 12AP
1999-02-02Manufacturing (CMC) · Supplement 11AP
1996-04-16Manufacturing (CMC) · Supplement 10AP
1995-05-08Manufacturing (CMC) · Supplement 9AP
1993-05-17Manufacturing (CMC) · Supplement 6AP
1989-11-08Labeling · Supplement 30AP
1989-11-08Labeling · Supplement 3AP
1989-05-09Manufacturing (CMC) · Supplement 1AP
1989-05-09Manufacturing (CMC) · Supplement 2AP
1988-10-18OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.