FDA Orange Book · active-ingredient family
Amlodipine besylate; valsartan
Amlodipine besylate; valsartan is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EXFORGE · NDA 021990
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EXFORGERLD×4 | NOVARTIS | NDA 021990 | AB | Jun 20, 2007 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND VALSARTAN×4 | MACLEODS PHARMS LTD | ANDA 207292 | AB | Oct 11, 2024 | |
| AMLODIPINE BESYLATE AND VALSARTAN×4 | HETERO LABS | ANDA 205137 | AB | Sep 16, 2016 | |
| AMLODIPINE BESYLATE AND VALSARTAN×4 | AUROBINDO PHARMA | ANDA 206512 | AB | Apr 22, 2016 | |
| AMLODIPINE BESYLATE AND VALSARTAN×4 | ALEMBIC | ANDA 202713 | AB | Apr 03, 2015 | |
| AMLODIPINE BESYLATE AND VALSARTAN×4 | LUPIN | ANDA 090245 | — | Mar 30, 2015 | |
| AMLODIPINE BESYLATE AND VALSARTAN×4 | MYLAN | ANDA 090483 | AB | Mar 30, 2015 | |
| AMLODIPINE BESYLATE AND VALSARTAN×4 | NOVEL LABS INC | ANDA 202829 | AB | Mar 30, 2015 | |
| AMLODIPINE BESYLATE AND VALSARTAN×4 | TEVA PHARMS USA | ANDA 091235 | — | Mar 30, 2015 | |
| AMLODIPINE BESYLATE AND VALSARTAN×4 | TORRENT | ANDA 202377 | — | Mar 30, 2015 | |
| AMLODIPINE BESYLATE AND VALSARTAN×4 | STRIDES PHARMA INTL | ANDA 090011 | AB | Mar 28, 2013 |
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; valsartan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
