APPLICATION
NDA005963
TYPE
NDA
ORIGINAL APPROVAL
1946-07-21
LATEST ACTION
2001-09-17
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS, OINTMENT
MARKETING STATUS
Discontinued
Products
SODIUM SULAMYD · ReferenceDiscontinued
SULFACETAMIDE SODIUM 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC
SODIUM SULAMYD · ReferenceDiscontinued
SULFACETAMIDE SODIUM 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC
SODIUM SULAMYD · ReferenceDiscontinued
SULFACETAMIDE SODIUM 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · OPHTHALMIC
Approval history
2001-09-17Labeling · Supplement 3AP
2001-09-17Labeling · Supplement 13AP
2001-09-17Labeling · Supplement 4AP
2001-09-17Labeling · Supplement 18 · standardAP
1986-10-01Labeling · Supplement 5AP
1946-07-21UNKNOWN · Original · unknownAP
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.