APPLICATION
NDA012546
TYPE
NDA
ORIGINAL APPROVAL
1960-11-17
LATEST ACTION
2013-12-19
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
TENUATE DOSPAN · ReferenceDiscontinued
DIETHYLPROPION HYDROCHLORIDE 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
Approval history
2013-12-19Manufacturing (CMC) · Supplement 33 · standardAP
2002-04-16Manufacturing (CMC) · Supplement 31 · standardAP
2000-02-09Manufacturing (CMC) · Supplement 30 · standardAP
1999-05-06Labeling · Supplement 29 · standardAP
1998-02-02Labeling · Supplement 27 · standardAP
1998-02-02Labeling · Supplement 25AP
1988-07-21Manufacturing (CMC) · Supplement 24 · standardAP
1988-06-17Labeling · Supplement 17AP
1986-10-03Manufacturing (CMC) · Supplement 22 · standardAP
1985-08-22Manufacturing (CMC) · Supplement 21 · standardAP
1983-12-23Manufacturing (CMC) · Supplement 20 · standardAP
1983-06-08Manufacturing (CMC) · Supplement 19 · standardAP
1982-12-06Labeling · Supplement 18AP
1982-10-18Manufacturing (CMC) · Supplement 16 · standardAP
1979-11-06Manufacturing (CMC) · Supplement 15 · standardAP
1978-04-27Manufacturing (CMC) · Supplement 14 · standardAP
1976-09-27Manufacturing (CMC) · Supplement 11 · standardAP
1975-06-24Manufacturing (CMC) · Supplement 9 · standardAP
1960-11-17Type 2 - New Active Ingredient · 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.