APPLICATION
ANDA214055
TYPE
ANDA
ORIGINAL APPROVAL
2026-04-16
LATEST ACTION
2026-04-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SELEXIPAGPrescription
SELEXIPAG 1.4MG · TABLET · ORAL
SELEXIPAGPrescription
SELEXIPAG 1MG · TABLET · ORAL
SELEXIPAGPrescription
SELEXIPAG 0.6MG · TABLET · ORAL
SELEXIPAGPrescription
SELEXIPAG 0.2MG · TABLET · ORAL
SELEXIPAGPrescription
SELEXIPAG 1.6MG · TABLET · ORAL
SELEXIPAGPrescription
SELEXIPAG 1.2MG · TABLET · ORAL
SELEXIPAGPrescription
SELEXIPAG 0.8MG · TABLET · ORAL
SELEXIPAGPrescription
SELEXIPAG 0.4MG · TABLET · ORAL
Approval history
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.