FDA Orange Book · active-ingredient family
Amlodipine besylate; olmesartan medoxomil
Amlodipine besylate; olmesartan medoxomil is approved as 1 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AZOR · NDA 022100
1
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AZORRLD×4 | COSETTE | NDA 022100 | AB | Sep 26, 2007 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMLODIPINE AND OLMESARTAN MEDOXOMIL×4 | HETERO LABS LTD V | ANDA 209591 | AB | Feb 14, 2025 | |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL×4 | SCIEGEN PHARMS | ANDA 209010 | AB | Dec 03, 2018 | |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL×4 | ACCORD HLTHCARE INC | ANDA 209600 | — | Aug 30, 2018 | |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL×4 | MICRO LABS | ANDA 207435 | AB | Nov 02, 2017 | |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL×4 | ZYDUS PHARMS | ANDA 207771 | AB | Sep 22, 2017 | |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL×4 | ALKEM LABS LTD | ANDA 209042 | AB | Aug 14, 2017 | |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL×4 | ALEMBIC | ANDA 207073 | AB | Jul 17, 2017 | |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL×4 | GLENMARK PHARMS LTD | ANDA 207807 | — | Jul 05, 2017 | |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL×4 | AUROBINDO PHARMA | ANDA 206906 | AB | May 15, 2017 | |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL×4 | JUBILANT GENERICS | ANDA 207450 | — | May 15, 2017 | |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL×4 | TORRENT | ANDA 202933 | — | Nov 25, 2016 | |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL×4 | AJANTA PHARMA LTD | ANDA 207216 | AB | Oct 28, 2016 | |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL×4 | MACLEODS PHARMS LTD | ANDA 206884 | AB | Oct 26, 2016 | |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL×4 | TEVA PHARMS USA | ANDA 091154 | — | 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; olmesartan medoxomil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
