FDA Orange Book · active-ingredient family
Amlodipine besylate; hydrochlorothiazide; valsartan
Amlodipine besylate; hydrochlorothiazide; valsartan is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EXFORGE HCT · NDA 022314
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EXFORGE HCTRLD×5 | NOVARTIS | NDA 022314 | AB | Apr 30, 2009 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | MACLEODS PHARMS LTD | ANDA 207299 | AB | Jan 07, 2025 | |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | AUROBINDO PHARMA | ANDA 206180 | AB | Dec 19, 2017 | |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | LUPIN | ANDA 200797 | AB | Jun 03, 2015 | |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | TORRENT | ANDA 201593 | — | Jun 03, 2015 | |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | STRIDES PHARMA INTL | ANDA 201087 | AB | Jun 01, 2015 | |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | TEVA PHARMS | ANDA 200435 | — | Sep 25, 2012 |
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; valsartan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
