APPLICATION
ANDA085411
TYPE
ANDA
ORIGINAL APPROVAL
1980-09-10
LATEST ACTION
1998-11-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PHENTERMINE HYDROCHLORIDEDiscontinued
PHENTERMINE HYDROCHLORIDE 30MG · CAPSULE · ORAL
Approval history
1998-11-03Labeling · Supplement 18AP
1998-08-19Labeling · Supplement 17AP
1998-04-08Labeling · Supplement 16AP
1997-12-19Labeling · Supplement 15AP
1992-10-16Manufacturing (CMC) · Supplement 14AP
1989-09-12Labeling · Supplement 12AP
1988-06-27Manufacturing (CMC) · Supplement 11AP
1988-06-27Manufacturing (CMC) · Supplement 10AP
1984-04-26Manufacturing (CMC) · Supplement 9AP
1983-12-20Manufacturing (CMC) · Supplement 6AP
1983-12-20Manufacturing (CMC) · Supplement 7AP
1983-06-09Manufacturing (CMC) · Supplement 3AP
1980-09-10OriginalAP
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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