APPLICATION
ANDA080059
TYPE
ANDA
ORIGINAL APPROVAL
1975-08-12
LATEST ACTION
1975-08-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NEOPASALATEDiscontinued
AMINOSALICYLATE SODIUM 846MG, AMINOSALICYLIC ACID 112MG · TABLET · ORAL
Approval history
1975-08-12OriginalAP
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.