← FDA DRUG APPROVALS

FDA NDA · NDA017078

DEXEDRINE SPANSULE

dextroamphetamine sulfate

Sponsor: IMPAX LABS INC

APPLICATION
NDA017078
TYPE
NDA
ORIGINAL APPROVAL
1976-08-02
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

DEXEDRINE SPANSULE · ReferencePrescription
DEXTROAMPHETAMINE SULFATE 15MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXEDRINE SPANSULE · ReferencePrescription
DEXTROAMPHETAMINE SULFATE 5MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXEDRINE SPANSULE · ReferencePrescription
DEXTROAMPHETAMINE SULFATE 10MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2025-09-23Labeling · Supplement 59 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 55 · standard — Letter ↗AP
2022-02-25Labeling · Supplement 54 · 901 required — Letter ↗AP
2019-01-15Labeling · Supplement 52 · standard — Label ↗AP
2017-05-19Labeling · Supplement 50 · 901 required — Label ↗AP
2017-01-04Labeling · Supplement 49 · 901 required — Label ↗AP
2015-04-17Labeling · Supplement 48 · 901 required — Label ↗AP
2013-12-06Labeling · Supplement 47 · standard — Letter ↗AP
2013-06-11Labeling · Supplement 46 · standard — Letter ↗AP
2008-05-23Labeling · Supplement 44 · standard — Letter ↗AP
2007-05-01Labeling · Supplement 42 · standard — Letter ↗AP
2006-08-10Labeling · Supplement 40 · standard — Letter ↗AP
2000-10-20Manufacturing (CMC) · Supplement 38 · standardAP
2000-04-13Manufacturing (CMC) · Supplement 37 · standardAP
1999-11-03Labeling · Supplement 34 · standardAP
1999-10-07Manufacturing (CMC) · Supplement 35 · standardAP
1999-10-07Manufacturing (CMC) · Supplement 36 · standardAP
1998-12-03Manufacturing (CMC) · Supplement 33 · standardAP
1998-06-12Manufacturing (CMC) · Supplement 32 · standardAP
1998-04-06Manufacturing (CMC) · Supplement 31 · standardAP
1998-04-06Manufacturing (CMC) · Supplement 30 · standardAP
1997-07-09Labeling · Supplement 27 · standardAP
1994-09-12Labeling · Supplement 25 · standardAP
1993-07-21Labeling · Supplement 22AP
1987-12-16Labeling · Supplement 21AP
1987-12-02Labeling · Supplement 20AP
1983-02-22Labeling · Supplement 17AP
1982-08-25Labeling · Supplement 19AP
1982-08-25Labeling · Supplement 18AP
1980-10-06Labeling · Supplement 16AP
1980-09-19Labeling · Supplement 15AP
1980-08-29Labeling · Supplement 13AP
1980-08-29Labeling · Supplement 14AP
1980-08-29Labeling · Supplement 12AP
1980-04-16Labeling · Supplement 11AP
1979-08-30Labeling · Supplement 9AP
1979-06-27Labeling · Supplement 8AP
1979-06-06Labeling · Supplement 7AP
1979-03-30Labeling · Supplement 5AP
1979-03-30Labeling · Supplement 3AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →