APPLICATION
ANDA087022
TYPE
ANDA
ORIGINAL APPROVAL
1983-02-03
LATEST ACTION
2017-05-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PHENTERMINE HYDROCHLORIDEDiscontinued
PHENTERMINE HYDROCHLORIDE 30MG · CAPSULE · ORAL
PHENTERMINE HYDROCHLORIDEDiscontinued
PHENTERMINE HYDROCHLORIDE 15MG · CAPSULE · ORAL
Approval history
2017-05-31Labeling · Supplement 21 · standardAP
2013-03-14Manufacturing (CMC) · Supplement 15AP
2012-12-05Labeling · Supplement 14 · standardAP
2012-04-19Labeling · Supplement 12AP
2012-04-19Labeling · Supplement 13AP
2012-01-20Manufacturing (CMC) · Supplement 9AP
2010-08-27Labeling · Supplement 11AP
2010-06-28Labeling · Supplement 10AP
2007-12-06Labeling · Supplement 4AP
1983-02-03OriginalAP
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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