APPLICATION
ANDA088576
TYPE
ANDA
ORIGINAL APPROVAL
1984-05-23
LATEST ACTION
2000-10-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PHENTERMINE HYDROCHLORIDEDiscontinued
PHENTERMINE HYDROCHLORIDE 18.75MG · CAPSULE · ORAL
Approval history
2000-10-06Manufacturing (CMC) · Supplement 16AP
1998-11-03Labeling · Supplement 14AP
1998-08-19Labeling · Supplement 13AP
1998-04-08Labeling · Supplement 12AP
1997-12-19Labeling · Supplement 11AP
1992-10-16Manufacturing (CMC) · Supplement 9AP
1990-02-16Labeling · Supplement 7AP
1989-05-02Labeling · Supplement 6AP
1988-06-27Manufacturing (CMC) · Supplement 4AP
1988-06-27Manufacturing (CMC) · Supplement 5AP
1984-07-09Manufacturing (CMC) · Supplement 1AP
1984-05-23OriginalAP
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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