APPLICATION
ANDA200181
TYPE
ANDA
ORIGINAL APPROVAL
2010-12-08
LATEST ACTION
2014-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PHENELZINE SULFATEPrescription
PHENELZINE SULFATE EQ 15MG BASE · TABLET · ORAL
Approval history
2014-07-17Labeling · Supplement 2 · standardAP
2010-12-08OriginalAP
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.