Orange Book product · Generic (ANDA)
DABIGATRAN ETEXILATE MESYLATE
DABIGATRAN ETEXILATE MESYLATE
At a glance
Dec 19, 2024
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 19, 2024
1 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
DABIGATRAN ETEXILATE MESYLATE
Strength
EQ 75MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 207922
Product number
001
Marketing status
DISCN
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 208039 · AUROBINDO PHARMA
- 2025DABIGATRAN ETEXILATE MESYLATEGeneric (ANDA)
ANDA 208067 · MYLAN
- 2025DABIGATRAN ETEXILATE MESYLATEGeneric (ANDA)
ANDA 208048 · DR REDDYS
- 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.
