APPLICATION
ANDA209430
TYPE
ANDA
ORIGINAL APPROVAL
2019-03-01
LATEST ACTION
2025-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DAPSONEDiscontinued
DAPSONE 25MG · TABLET · ORAL
DAPSONEDiscontinued
DAPSONE 100MG · TABLET · ORAL
Approval history
2025-04-23Labeling · Supplement 1 · standardAP
2019-03-01UNKNOWN · Original · standardAP
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.