APPLICATION
ANDA087078
TYPE
ANDA
ORIGINAL APPROVAL
1981-02-23
LATEST ACTION
1991-03-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SPIRONOLACTONEDiscontinued
SPIRONOLACTONE 25MG · TABLET · ORAL
Approval history
1991-03-25Labeling · Supplement 21AP
1981-02-23OriginalAP
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.