Orange Book product · Generic (ANDA)
ESLICARBAZEPINE ACETATE
ESLICARBAZEPINE ACETATE
At a glance
Feb 27, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 27, 2024
2 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ESLICARBAZEPINE ACETATE
Strength
200MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 211227
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ESLICARBAZEPINE ACETATE
- 2013APTIOMBrand (NDA)
NDA 022416 · SUMITOMO PHARMA AM
- 2025ESLICARBAZEPINE ACETATEGeneric (ANDA)
ANDA 211247 · SPH ZHONGXI PHARM
- 2025ESLICARBAZEPINE ACETATEGeneric (ANDA)
ANDA 211219 · JUBILANT GENERICS
- 2024ESLICARBAZEPINE ACETATEGeneric (ANDA)
ANDA 211246 · LUPIN
- 2023ESLICARBAZEPINE ACETATEGeneric (ANDA)
ANDA 211236 · APOTEX
- 2023ESLICARBAZEPINE ACETATEGeneric (ANDA)
ANDA 211199 · ALKEM LABS LTD
- 2023ESLICARBAZEPINE ACETATEGeneric (ANDA)
ANDA 211186 · HETERO LABS LTD V
- 2021ESLICARBAZEPINE ACETATEGeneric (ANDA)
ANDA 211238 · DR REDDYS
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.

