APPLICATION
ANDA083808
TYPE
ANDA
ORIGINAL APPROVAL
1977-02-14
LATEST ACTION
1989-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
QUINIDINE SULFATEDiscontinued
QUINIDINE SULFATE 200MG · TABLET · ORAL
Approval history
1989-10-13Labeling · Supplement 21AP
1988-12-19Manufacturing (CMC) · Supplement 19AP
1988-09-20Manufacturing (CMC) · Supplement 20AP
1985-12-19Manufacturing (CMC) · Supplement 18AP
1985-08-02Manufacturing (CMC) · Supplement 17AP
1985-08-02Manufacturing (CMC) · Supplement 16AP
1985-05-15Manufacturing (CMC) · Supplement 15AP
1985-05-15Manufacturing (CMC) · Supplement 14AP
1977-02-14OriginalAP
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.