Composition
- Active ingredients
- DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE · CapsuleNDA022512-003 · Prescription
- DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE · CapsuleThis page
- DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE · CapsuleNDA022512-002 · Prescription
- DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE/PACKET · PelletsNDA214358-005 · Prescription
- DABIGATRAN ETEXILATE MESYLATE EQ 40MG BASE/PACKET · PelletsNDA214358-003 · Prescription
- DABIGATRAN ETEXILATE MESYLATE EQ 20MG BASE/PACKET · PelletsNDA214358-001 · Prescription
- DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE/PACKET · PelletsNDA214358-006 · Prescription
- DABIGATRAN ETEXILATE MESYLATE EQ 50MG BASE/PACKET · PelletsNDA214358-004 · Prescription
- DABIGATRAN ETEXILATE MESYLATE EQ 30MG BASE/PACKET · PelletsNDA214358-002 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA022512.
At a glance
- Brand name
- Pradaxa
- Active substance
- dabigatran etexilate mesylate
- Route
- Oral
- Dosage form
- Capsule
- Applicant
- Boehringer Ingelheim
- Status
- Prescription
- FDA approval
- 19 Oct 2010
- Application
- NDA022512-001