APPLICATION
ANDA213879
TYPE
ANDA
ORIGINAL APPROVAL
2024-05-22
LATEST ACTION
2024-10-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DABIGATRAN ETEXILATE MESYLATEPrescription
DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE · CAPSULE · ORAL
DABIGATRAN ETEXILATE MESYLATEPrescription
DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE · CAPSULE · ORAL
DABIGATRAN ETEXILATE MESYLATEPrescription
DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE · CAPSULE · ORAL
Approval history
2024-10-01Manufacturing (CMC) · Supplement 2 · unknownAP
2024-08-12UNKNOWN · 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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