APPLICATION
ANDA088007
TYPE
ANDA
ORIGINAL APPROVAL
1983-04-19
LATEST ACTION
1983-04-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Discontinued
Products
PREDSULFAIRDiscontinued
PREDNISOLONE ACETATE 0.5%, SULFACETAMIDE SODIUM 10% · SUSPENSION/DROPS · OPHTHALMIC
Approval history
1983-04-19OriginalAP
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.