APPLICATION
NDA017669
TYPE
NDA
ORIGINAL APPROVAL
1975-03-20
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
TENUATEDiscontinued
DIETHYLPROPION HYDROCHLORIDE 75MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2007-12-07Labeling · Supplement 2AP
1981-05-18Labeling · Supplement 9AP
1979-11-02Manufacturing (CMC) · Supplement 8 · standardAP
1978-04-27Manufacturing (CMC) · Supplement 7 · standardAP
1976-09-28Manufacturing (CMC) · Supplement 3 · standardAP
1976-09-28Manufacturing (CMC) · Supplement 4 · standardAP
1975-06-19Manufacturing (CMC) · Supplement 1 · standardAP
1975-03-20Type 5 - New Formulation or New Manufacturer · 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.
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