APPLICATION
ANDA087764
TYPE
ANDA
ORIGINAL APPROVAL
1982-03-18
LATEST ACTION
1993-07-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
OBY-TRIMDiscontinued
PHENTERMINE HYDROCHLORIDE 30MG · CAPSULE · ORAL
Approval history
1993-07-30Manufacturing (CMC) · Supplement 7AP
1990-06-15Manufacturing (CMC) · Supplement 4AP
1989-07-06Bioequivalence · Supplement 8AP
1988-12-07Labeling · Supplement 3AP
1982-03-18OriginalAP
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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