FDA Orange Book · active-ingredient family
Amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
Amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TRIBENZOR · NDA 200175
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRIBENZORRLD×5 | COSETTE | NDA 200175 | AB | Jul 23, 2010 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE×5 | MICRO LABS | ANDA 207437 | AB | Nov 24, 2025 | |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE×5 | HETERO LABS LTD V | ANDA 209242 | AB | Oct 06, 2025 | |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE×5 | MACLEODS PHARMS LTD | ANDA 207088 | AB | Jul 18, 2025 | |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE×5 | PIRAMAL | ANDA 210718 | AB | May 14, 2025 | |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE×5 | TEVA PHARMS USA | ANDA 202491 | AB | Nov 03, 2016 | |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE×5 | PH HEALTH | ANDA 206137 | AB | Oct 26, 2016 | |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE×5 | TORRENT | ANDA 203580 | — | Oct 26, 2016 |
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.
Amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
