APPLICATION
ANDA210108
TYPE
ANDA
ROUTE
FILM COATED
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
APIXABANNone (Tentative Approval)
APIXABAN 2.5MG · TABLET · FILM COATED
APIXABANNone (Tentative Approval)
APIXABAN 2.0MG · TABLET · FILM COATED
APIXABANNone (Tentative Approval)
APIXABAN 5MG · TABLET · FILM COATED
APIXABANNone (Tentative Approval)
APIXABAN 1.5MG · TABLET · FILM COATED
Approval history
2025-11-04UNKNOWN · Original · standardTA
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.