Orange Book product · Brand (NDA)
TRIBENZOR
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
At a glance
Jul 23, 2010
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 23, 2010
16 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Strength
EQ 5MG BASE;12.5MG;20MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 200175
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.
- 2025OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 207437 · MICRO LABS
- 2025OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 209242 · HETERO LABS LTD V
- 2025OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 207088 · MACLEODS PHARMS LTD
- 2025OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 210718 · PIRAMAL
- 2016OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 202491 · TEVA PHARMS USA
- 2016OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 206137 · PH HEALTH
- 2016OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 203580 · TORRENT
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.
