Orange Book product · Generic (ANDA)
DABIGATRAN ETEXILATE MESYLATE
DABIGATRAN ETEXILATE MESYLATE
At a glance
May 14, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 14, 2025
1 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
DABIGATRAN ETEXILATE MESYLATE
Strength
EQ 75MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 208039
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DABIGATRAN ETEXILATE MESYLATE
- 2021PRADAXABrand (NDA)
NDA 214358 · BOEHRINGER INGELHEIM
- 2010PRADAXABrand (NDA)
NDA 022512 · BOEHRINGER INGELHEIM
- 2025DABIGATRAN ETEXILATE MESYLATEGeneric (ANDA)
ANDA 208067 · MYLAN
- 2025DABIGATRAN ETEXILATE MESYLATEGeneric (ANDA)
ANDA 208048 · DR REDDYS
- 2024DABIGATRAN ETEXILATE MESYLATEGeneric (ANDA)
ANDA 207922 · BRECKENRIDGE
- 2024DABIGATRAN ETEXILATE MESYLATEGeneric (ANDA)
ANDA 215233 · ALEMBIC
- 2024DABIGATRAN ETEXILATE MESYLATEGeneric (ANDA)
ANDA 213879 · MSN
- 2023DABIGATRAN ETEXILATE MESYLATEGeneric (ANDA)
ANDA 208070 · APOTEX
- 2020DABIGATRAN ETEXILATE MESYLATEGeneric (ANDA)
ANDA 207961 · HETERO LABS LTD III
- 2020DABIGATRAN ETEXILATE MESYLATEGeneric (ANDA)
ANDA 208040 · ALKEM LABS LTD
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
