APPLICATION
ANDA086945
TYPE
ANDA
ORIGINAL APPROVAL
1983-07-20
LATEST ACTION
2017-05-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
PHENTERMINE HYDROCHLORIDE · ReferencePrescription
PHENTERMINE HYDROCHLORIDE 30MG · CAPSULE · ORAL
Approval history
2017-05-31Labeling · Supplement 30 · standardAP
2012-12-06Labeling · Supplement 25 · standardAP
2012-12-06Labeling · Supplement 26 · standardAP
2002-11-13Manufacturing (CMC) · Supplement 20AP
2001-01-11Manufacturing (CMC) · Supplement 18AP
2000-02-02Manufacturing (CMC) · Supplement 17AP
1998-09-24Labeling · Supplement 16AP
1998-08-10Labeling · Supplement 15AP
1998-04-30Labeling · Supplement 14AP
1997-01-16Manufacturing (CMC) · Supplement 9AP
1997-01-16Labeling · Supplement 12AP
1996-04-12Manufacturing (CMC) · Supplement 13AP
1994-12-19Manufacturing (CMC) · Supplement 8AP
1993-01-22Labeling · Supplement 11AP
1992-10-27Labeling · Supplement 10AP
1989-10-26Labeling · Supplement 7AP
1988-04-12Labeling · Supplement 6AP
1985-06-12Manufacturing (CMC) · Supplement 3AP
1985-01-30Manufacturing (CMC) · Supplement 2AP
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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