APPLICATION
ANDA089452
TYPE
ANDA
ORIGINAL APPROVAL
1991-10-30
LATEST ACTION
2013-07-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PHENDIMETRAZINE TARTRATEPrescription
PHENDIMETRAZINE TARTRATE 35MG · TABLET · ORAL
Approval history
2013-07-02Labeling · Supplement 15 · standardAP
2002-08-13Manufacturing (CMC) · Supplement 7AP
2001-08-21Manufacturing (CMC) · Supplement 6AP
1998-10-27Labeling · Supplement 4AP
1998-05-13Manufacturing (CMC) · Supplement 5AP
1998-02-17Manufacturing (CMC) · Supplement 3AP
1998-02-17Manufacturing (CMC) · Supplement 1AP
1998-02-17Manufacturing (CMC) · Supplement 2AP
1991-10-30OriginalAP
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.