APPLICATION
ANDA084487
TYPE
ANDA
ORIGINAL APPROVAL
1982-04-09
LATEST ACTION
1996-09-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PHENTERMINE HYDROCHLORIDEDiscontinued
PHENTERMINE HYDROCHLORIDE 30MG · CAPSULE · ORAL
Approval history
1996-09-17Manufacturing (CMC) · Supplement 20AP
1991-01-14Labeling · Supplement 19AP
1989-09-22Labeling · Supplement 18AP
1989-04-05Manufacturing (CMC) · Supplement 17AP
1986-07-03Manufacturing (CMC) · Supplement 9AP
1986-05-30Manufacturing (CMC) · Supplement 10AP
1986-05-22Manufacturing (CMC) · Supplement 8AP
1986-05-22Manufacturing (CMC) · Supplement 4AP
1986-05-22Manufacturing (CMC) · Supplement 3AP
1985-10-08Manufacturing (CMC) · Supplement 7AP
1982-07-02Manufacturing (CMC) · Supplement 1AP
1982-04-09OriginalAP
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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