Orange Book product · Brand (NDA)
BENICAR
OLMESARTAN MEDOXOMIL
At a glance
Apr 25, 2002
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 25, 2002
24 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
OLMESARTAN MEDOXOMIL
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021286
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 210682 · CADILA PHARMS LTD
- 2024OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 205499 · HETERO LABS LTD V
- 2024OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 206227 · CHARTWELL RX
- 2023OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 207480 · AMNEAL
- 2023OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 217399 · MSN
- 2022OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 206720 · PRINSTON INC
- 2020OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 208659 · INVENTIA
- 2020OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 090237 · SANDOZ
- 2019OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 206372 · MICRO LABS
- 2019OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 207135 · UMEDICA
- 2019OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 211049 · SUNSHINE
- 2019OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 210552 · QILU
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.
