Orange Book product · Generic (ANDA)
EPLERENONE
EPLERENONE
At a glance
Jun 02, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 02, 2023
3 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
EPLERENONE
Strength
25MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 213812
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of EPLERENONE
- 2002INSPRABrand (NDA)
NDA 021437 · UPJOHN
- 2022EPLERENONEGeneric (ANDA)
ANDA 214663 · RISING
- 2021EPLERENONEGeneric (ANDA)
ANDA 207842 · WESTMINSTER PHARMS
- 2020EPLERENONEGeneric (ANDA)
ANDA 212765 · ADAPTIS
- 2018EPLERENONEGeneric (ANDA)
ANDA 208283 · BRECKENRIDGE
- 2017EPLERENONEGeneric (ANDA)
ANDA 206922 · ACCORD HLTHCARE
- 2017EPLERENONEGeneric (ANDA)
ANDA 203896 · INNOGENIX
- 2008EPLERENONEGeneric (ANDA)
ANDA 078510 · SANDOZ
- 2008EPLERENONEGeneric (ANDA)
ANDA 078482 · CHARTWELL RX
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.
