APPLICATION
ANDA087805
TYPE
ANDA
ORIGINAL APPROVAL
1982-12-06
LATEST ACTION
2000-10-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PHENTERMINE HYDROCHLORIDEDiscontinued
PHENTERMINE HYDROCHLORIDE 37.5MG · TABLET · ORAL
Approval history
2000-10-06Manufacturing (CMC) · Supplement 22AP
1999-10-19Labeling · Supplement 20AP
1998-11-03Labeling · Supplement 19AP
1998-08-19Labeling · Supplement 18AP
1998-04-08Labeling · Supplement 17AP
1997-12-19Labeling · Supplement 16AP
1992-06-30Manufacturing (CMC) · Supplement 13AP
1990-06-04Labeling · Supplement 12AP
1989-05-31Manufacturing (CMC) · Supplement 10AP
1989-05-02Labeling · Supplement 11AP
1988-06-27Manufacturing (CMC) · Supplement 8AP
1988-06-27Manufacturing (CMC) · Supplement 9AP
1983-12-22Manufacturing (CMC) · Supplement 4AP
1983-12-22Manufacturing (CMC) · Supplement 3AP
1983-02-10Manufacturing (CMC) · Supplement 1AP
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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