APPLICATION
NDA011722
TYPE
NDA
ORIGINAL APPROVAL
1959-08-06
LATEST ACTION
2004-09-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TENUATE · ReferenceDiscontinued
DIETHYLPROPION HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2000-07-14Manufacturing (CMC) · Supplement 28 · priorityAP
1999-05-06Labeling · Supplement 27 · standardAP
1998-02-02Labeling · Supplement 25 · standardAP
1988-07-21Manufacturing (CMC) · Supplement 24 · priorityAP
1988-06-17Labeling · Supplement 17AP
1986-10-03Manufacturing (CMC) · Supplement 22 · priorityAP
1984-02-10Manufacturing (CMC) · Supplement 21 · priorityAP
1984-01-06Manufacturing (CMC) · Supplement 20 · priorityAP
1983-08-03Manufacturing (CMC) · Supplement 16 · priorityAP
1983-06-08Manufacturing (CMC) · Supplement 19 · priorityAP
1982-12-06Labeling · Supplement 18AP
1982-10-18Manufacturing (CMC) · Supplement 15 · priorityAP
1979-10-31Manufacturing (CMC) · Supplement 14 · priorityAP
1978-04-27Manufacturing (CMC) · Supplement 13 · priorityAP
1976-09-23Manufacturing (CMC) · Supplement 11 · priorityAP
1976-02-12Manufacturing (CMC) · Supplement 10 · priorityAP
1959-08-06Type 1 - New Molecular Entity · Original · priorityAP
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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