APPLICATION
ANDA083903
TYPE
ANDA
ORIGINAL APPROVAL
1975-10-29
LATEST ACTION
2023-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DEXTROAMPHETAMINE SULFATEDiscontinued
DEXTROAMPHETAMINE SULFATE 10MG · TABLET · ORAL
DEXTROAMPHETAMINE SULFATEDiscontinued
DEXTROAMPHETAMINE SULFATE 5MG · TABLET · ORAL
Approval history
2023-10-13Labeling · Supplement 30 · standardAP
2022-02-25Labeling · Supplement 29 · standardAP
2017-01-04Labeling · Supplement 27 · standardAP
2015-04-17Labeling · Supplement 26 · standardAP
2003-04-08Labeling · Supplement 24AP
1991-09-19Labeling · Supplement 19AP
1991-09-19Manufacturing (CMC) · Supplement 17AP
1991-09-19Labeling · Supplement 16AP
1990-12-17Manufacturing (CMC) · Supplement 18AP
1987-06-05Manufacturing (CMC) · Supplement 13AP
1986-01-17Manufacturing (CMC) · Supplement 12AP
1986-01-03Manufacturing (CMC) · Supplement 11AP
1985-03-13Manufacturing (CMC) · Supplement 8AP
1975-10-29OriginalAP
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.