APPLICATION
ANDA207961
TYPE
ANDA
ORIGINAL APPROVAL
2020-05-06
LATEST ACTION
2026-06-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DABIGATRAN ETEXILATE MESYLATEPrescription
DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE · CAPSULE · ORAL
DABIGATRAN ETEXILATE MESYLATEPrescription
DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE · CAPSULE · ORAL
DABIGATRAN ETEXILATE MESYLATEPrescription
DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE · CAPSULE · ORAL
Approval history
2026-06-05Labeling · Supplement 13 · standardAP
2025-02-24Labeling · Supplement 11 · standardAP
2024-08-13UNKNOWN · Original · 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.
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