Orange Book product · Generic (ANDA)
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
At a glance
May 14, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 14, 2025
1 yr 1 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 210718
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 207088 · MACLEODS PHARMS LTD
- 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.
