APPLICATION
NDA017668
TYPE
NDA
ORIGINAL APPROVAL
1975-03-20
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TENUATEDiscontinued
DIETHYLPROPION HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
2007-12-07Labeling · Supplement 1AP
1981-05-18Labeling · Supplement 10AP
1980-05-27Labeling · Supplement 9AP
1980-05-12Manufacturing (CMC) · Supplement 8 · standardAP
1979-11-02Manufacturing (CMC) · Supplement 7 · standardAP
1978-04-27Manufacturing (CMC) · Supplement 6 · standardAP
1976-09-24Manufacturing (CMC) · Supplement 3 · standardAP
1976-09-24Manufacturing (CMC) · Supplement 4 · standardAP
1976-03-10Manufacturing (CMC) · Supplement 2 · standardAP
1975-03-20Type 3 - New Dosage Form · 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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