FDA Orange Book · active-ingredient family
Nebivolol hydrochloride; valsartan
Nebivolol hydrochloride; valsartan is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BYVALSON · NDA 206302
1
Brand (NDA)
1
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BYVALSONRLD | ABBVIE | NDA 206302 | — | Jun 03, 2016 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VYDUO | PRINSTON INC | ANDA 210596 | — | Sep 19, 2022 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7803838 | Aug 29, 2026 | in 2 mo | Product |
| 7838552 | Oct 04, 2027 | in 1 yr 4 mo | U-185 |
Nebivolol hydrochloride; valsartan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
