APPLICATION
ANDA070187
TYPE
ANDA
ORIGINAL APPROVAL
1985-11-18
LATEST ACTION
1992-04-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DISOPYRAMIDE PHOSPHATEDiscontinued
DISOPYRAMIDE PHOSPHATE EQ 150MG BASE · CAPSULE · ORAL
Approval history
1992-04-22Labeling · Supplement 6AP
1991-10-11Labeling · Supplement 5AP
1988-06-10Labeling · Supplement 3AP
1987-09-09Manufacturing (CMC) · Supplement 2AP
1987-09-09Manufacturing (CMC) · Supplement 1AP
1985-11-18OriginalAP
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.