APPLICATION
ANDA086842
TYPE
ANDA
ORIGINAL APPROVAL
1979-07-03
LATEST ACTION
2025-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DAPSONE · ReferencePrescription
DAPSONE 100MG · TABLET · ORAL
Approval history
2025-04-23Labeling · Supplement 21 · standardAP
2009-08-24Labeling · Supplement 18AP
1992-08-19Manufacturing (CMC) · Supplement 13AP
1988-07-13Manufacturing (CMC) · Supplement 9AP
1988-07-13Labeling · Supplement 12AP
1983-12-02Manufacturing (CMC) · Supplement 8AP
1982-05-04Manufacturing (CMC) · Supplement 3AP
1982-05-04Manufacturing (CMC) · Supplement 1AP
1979-07-03OriginalAP
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.
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