Orange Book product · Generic (ANDA)
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
At a glance
Jul 18, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 18, 2025
11 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
ANDA 207088
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
- 2010TRIBENZORBrand (NDA)
NDA 200175 · COSETTE
- 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 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.
