Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsORALStandard

DABIGATRAN ETEXILATE MESYLATE

DABIGATRAN ETEXILATE MESYLATE

Standard Dose
EQ 110MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DABIGATRAN ETEXILATE MESYLATE is listed in Drugs@FDA under application 215233 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DABIGATRAN ETEXILATE MESYLATE Form and strength CAPSULE;ORAL - EQ 110MG BASE Sponsor ALEMBIC Submission history Latest submission status date: 2024-08-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview DABIGATRAN ETEXILATE MESYLATE is listed in Drugs@FDA under application 215233 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DABIGATRAN ETEXILATE MESYLATE Form and strength CAPSULE;ORAL - EQ 110MG BASE Sponsor ALEMBIC Submission history Latest submission status date: 2024-08-12 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.