APPLICATION
ANDA085417
TYPE
ANDA
ORIGINAL APPROVAL
1980-09-10
LATEST ACTION
2000-10-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PHENTERMINE HYDROCHLORIDEDiscontinued
PHENTERMINE HYDROCHLORIDE 30MG · CAPSULE · ORAL
Approval history
2000-10-06Manufacturing (CMC) · Supplement 26AP
1998-11-03Labeling · Supplement 24AP
1998-08-19Labeling · Supplement 23AP
1998-04-08Labeling · Supplement 22AP
1997-12-19Labeling · Supplement 21AP
1992-10-16Manufacturing (CMC) · Supplement 20AP
1989-09-19Labeling · Supplement 18AP
1989-05-31Manufacturing (CMC) · Supplement 17AP
1988-06-27Manufacturing (CMC) · Supplement 16AP
1988-06-27Manufacturing (CMC) · Supplement 15AP
1984-04-25Manufacturing (CMC) · Supplement 13AP
1983-12-21Manufacturing (CMC) · Supplement 10AP
1983-12-21Manufacturing (CMC) · Supplement 11AP
1983-06-14Manufacturing (CMC) · Supplement 7AP
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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