APPLICATION
NDA017956
TYPE
NDA
ORIGINAL APPROVAL
1977-05-25
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
TEPANIL TEN-TABDiscontinued
DIETHYLPROPION HYDROCHLORIDE 75MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2007-12-07Labeling · Supplement 20AP
2007-12-07Labeling · Supplement 17AP
1996-03-14Manufacturing (CMC) · Supplement 25 · standardAP
1995-11-28Manufacturing (CMC) · Supplement 26 · standardAP
1987-06-16Manufacturing (CMC) · Supplement 24 · standardAP
1987-02-17Labeling · Supplement 23AP
1985-08-26Manufacturing (CMC) · Supplement 22 · standardAP
1985-08-26Manufacturing (CMC) · Supplement 21 · standardAP
1981-07-01Labeling · Supplement 18AP
1981-07-01Labeling · Supplement 16AP
1981-07-01Labeling · Supplement 14AP
1981-07-01Labeling · Supplement 9AP
1981-07-01Labeling · Supplement 12AP
1981-07-01Labeling · Supplement 7AP
1981-07-01Labeling · Supplement 10AP
1981-07-01Labeling · Supplement 19AP
1981-07-01Labeling · Supplement 15AP
1981-07-01Labeling · Supplement 13AP
1981-07-01Labeling · Supplement 8AP
1981-07-01Labeling · Supplement 11AP
1981-07-01Labeling · Supplement 6AP
1981-02-23Manufacturing (CMC) · Supplement 5 · standardAP
1980-09-18Manufacturing (CMC) · Supplement 4 · standardAP
1980-05-02Labeling · Supplement 2AP
1978-11-17Manufacturing (CMC) · Supplement 1 · standardAP
1977-05-25Type 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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