APPLICATION
ANDA083923
TYPE
ANDA
ORIGINAL APPROVAL
1976-07-01
LATEST ACTION
2025-07-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PHENTERMINE HYDROCHLORIDEDiscontinued
PHENTERMINE HYDROCHLORIDE 8MG · TABLET · ORAL
Approval history
2025-07-24Labeling · Supplement 48 · standardAP
2000-10-06Manufacturing (CMC) · Supplement 47AP
1999-06-01Labeling · Supplement 45AP
1998-04-08Labeling · Supplement 44AP
1997-12-19Labeling · Supplement 43AP
1992-10-16Manufacturing (CMC) · Supplement 41AP
1990-06-05Labeling · Supplement 39AP
1989-09-15Labeling · Supplement 37AP
1989-05-31Manufacturing (CMC) · Supplement 38AP
1988-06-27Manufacturing (CMC) · Supplement 35AP
1983-02-11Manufacturing (CMC) · Supplement 30AP
1983-02-11Manufacturing (CMC) · Supplement 29AP
1982-12-01Manufacturing (CMC) · Supplement 28AP
1976-07-01OriginalAP
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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