APPLICATION
ANDA087918
TYPE
ANDA
ORIGINAL APPROVAL
1983-12-22
LATEST ACTION
2000-10-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PHENTERMINE HYDROCHLORIDEDiscontinued
PHENTERMINE HYDROCHLORIDE 37.5MG · CAPSULE · ORAL
Approval history
2000-10-06Manufacturing (CMC) · Supplement 20AP
1999-06-01Labeling · Supplement 18AP
1998-11-03Labeling · Supplement 17AP
1998-08-19Labeling · Supplement 16AP
1998-04-08Labeling · Supplement 15AP
1997-12-19Labeling · Supplement 14AP
1992-10-16Manufacturing (CMC) · Supplement 13AP
1990-07-27Labeling · Supplement 11AP
1990-02-06Labeling · Supplement 10AP
1989-05-31Manufacturing (CMC) · Supplement 8AP
1989-03-15Labeling · Supplement 9AP
1988-06-27Manufacturing (CMC) · Supplement 7AP
1988-06-27Manufacturing (CMC) · Supplement 6AP
1984-01-27Manufacturing (CMC) · Supplement 1AP
1983-12-22OriginalAP
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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