APPLICATION
ANDA085319
TYPE
ANDA
ORIGINAL APPROVAL
1977-03-14
LATEST ACTION
2000-10-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PHENTERMINE HYDROCHLORIDEDiscontinued
PHENTERMINE HYDROCHLORIDE 8MG · TABLET · ORAL
Approval history
2000-10-06Manufacturing (CMC) · Supplement 36AP
1999-06-01Labeling · Supplement 34AP
1998-04-08Labeling · Supplement 33AP
1997-12-19Labeling · Supplement 32AP
1992-10-16Manufacturing (CMC) · Supplement 30AP
1990-01-19Labeling · Supplement 25AP
1989-05-31Manufacturing (CMC) · Supplement 28AP
1988-06-27Manufacturing (CMC) · Supplement 27AP
1988-06-27Manufacturing (CMC) · Supplement 26AP
1986-07-15Manufacturing (CMC) · Supplement 20AP
1983-05-12Manufacturing (CMC) · Supplement 22AP
1983-02-04Manufacturing (CMC) · Supplement 21AP
1982-12-16Manufacturing (CMC) · Supplement 19AP
1977-03-14OriginalAP
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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