APPLICATION
ANDA040525
TYPE
ANDA
ORIGINAL APPROVAL
2003-10-23
LATEST ACTION
2017-05-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PHENTERMINE HYDROCHLORIDEDiscontinued
PHENTERMINE HYDROCHLORIDE 30MG · CAPSULE · ORAL
Approval history
2017-05-31Labeling · Supplement 17 · standardAP
2012-12-06Labeling · Supplement 11 · standardAP
2012-12-06Labeling · Supplement 12 · standardAP
2003-10-23OriginalAP
2003-10-23UNKNOWN · Supplement 1 · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.