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FDA NDA · NDA005378

DESOXYN

Sponsor: AJENAT PHARMS

APPLICATION
NDA005378
TYPE
NDA
ORIGINAL APPROVAL
1943-12-31
LATEST ACTION
2024-09-24
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE, TABLET
MARKETING STATUS
Discontinued, Prescription

Products

DESOXYNDiscontinued
METHAMPHETAMINE HYDROCHLORIDE 15MG · TABLET, EXTENDED RELEASE · ORAL
DESOXYNDiscontinued
METHAMPHETAMINE HYDROCHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
DESOXYNDiscontinued
METHAMPHETAMINE HYDROCHLORIDE 5MG · TABLET, EXTENDED RELEASE · ORAL
DESOXYN · ReferencePrescription
METHAMPHETAMINE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2024-09-24Labeling · Supplement 32 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 38 · standard — Letter ↗AP
2022-02-25Labeling · Supplement 37 · 901 required — Letter ↗AP
2019-04-11Labeling · Supplement 35 · standard — Letter ↗AP
2017-05-19Labeling · Supplement 34 · 901 required — Label ↗AP
2017-01-04Labeling · Supplement 31 · 901 required — Label ↗AP
2015-04-17Labeling · Supplement 30 · 901 required — Letter ↗AP
2015-01-26Manufacturing (CMC) · Supplement 29AP
2013-12-03Labeling · Supplement 28 · standard — Letter ↗AP
2013-08-23Labeling · Supplement 27 · standard — Letter ↗AP
2007-05-11Labeling · Supplement 26 · standard — Letter ↗AP
2006-04-12Labeling · Supplement 24 · standard — Letter ↗AP
2001-12-06Labeling · Supplement 20 · standard — Label ↗AP
2000-11-20Manufacturing (CMC) · Supplement 23AP
1999-06-16Manufacturing (CMC) · Supplement 22AP
1998-05-13Manufacturing (CMC) · Supplement 21AP
1989-07-27Manufacturing (CMC) · Supplement 19AP
1984-02-22Labeling · Supplement 13AP
1983-06-27Labeling · Supplement 15AP
1983-04-25Labeling · Supplement 16AP
1982-09-22Manufacturing (CMC) · Supplement 14AP
1981-09-30Manufacturing (CMC) · Supplement 11AP
1979-03-30Labeling · Supplement 9AP
1975-07-22Manufacturing (CMC) · Supplement 5AP
1975-07-22Labeling · Supplement 3AP
1975-07-22Labeling · Supplement 6AP
1943-12-31UNKNOWN · Original · unknown — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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