APPLICATION
ANDA087301
TYPE
ANDA
ORIGINAL APPROVAL
1981-06-12
LATEST ACTION
2000-02-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PHENTERMINE HYDROCHLORIDEDiscontinued
PHENTERMINE HYDROCHLORIDE 15MG · CAPSULE · ORAL
Approval history
2000-02-02Manufacturing (CMC) · Supplement 23AP
1998-09-24Labeling · Supplement 22AP
1998-08-10Labeling · Supplement 21AP
1998-04-30Labeling · Supplement 20AP
1996-06-26Manufacturing (CMC) · Supplement 17AP
1996-04-12Manufacturing (CMC) · Supplement 19AP
1996-01-19Manufacturing (CMC) · Supplement 18AP
1994-12-19Manufacturing (CMC) · Supplement 14AP
1993-01-22Labeling · Supplement 16AP
1992-08-10Labeling · Supplement 15AP
1989-10-03Labeling · Supplement 27AP
1989-10-03Labeling · Supplement 12AP
1988-04-12Labeling · Supplement 10AP
1987-01-23Manufacturing (CMC) · Supplement 8AP
1987-01-23Manufacturing (CMC) · Supplement 9AP
1985-01-30Manufacturing (CMC) · Supplement 7AP
1983-11-10Manufacturing (CMC) · Supplement 5AP
1983-09-02Manufacturing (CMC) · Supplement 3AP
1983-09-02Manufacturing (CMC) · Supplement 4AP
1982-02-03Manufacturing (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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