FDA Orange Book · active-ingredient family
Nebivolol hydrochloride
Nebivolol hydrochloride is approved as 1 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BYSTOLIC · NDA 021742
1
Brand (NDA)
18
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BYSTOLICRLD×4 | ALLERGAN | NDA 021742 | AB | Dec 17, 2007 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEBIVOLOL HYDROCHLORIDE×4 | MACLEODS PHARMS LTD | ANDA 212661 | AB | Jan 28, 2025 | |
| NEBIVOLOL HYDROCHLORIDE×4 | MSN | ANDA 217397 | AB | Oct 01, 2024 | |
| NEBIVOLOL HYDROCHLORIDE×2 | APOTEX | ANDA 209741 | — | Feb 27, 2024 | |
| NEBIVOLOL HYDROCHLORIDE×4 | REGCON HOLDINGS | ANDA 216568 | AB | Mar 30, 2023 | |
| NEBIVOLOL HYDROCHLORIDE×4 | MANKIND PHARMA | ANDA 216172 | AB | Nov 14, 2022 | |
| NEBIVOLOL HYDROCHLORIDE×4 | PRINSTON INC | ANDA 212682 | AB | Apr 07, 2022 | |
| NEBIVOLOL HYDROCHLORIDE×4 | CHARTWELL RX | ANDA 213349 | — | Mar 31, 2022 | |
| NEBIVOLOL HYDROCHLORIDE×4 | UNICHEM | ANDA 213830 | AB | Mar 15, 2022 | |
| NEBIVOLOL HYDROCHLORIDE×4 | AUROBINDO PHARMA LTD | ANDA 211053 | AB | Dec 17, 2021 | |
| NEBIVOLOL HYDROCHLORIDE×4 | CADILA PHARMS LTD | ANDA 208717 | AB | Dec 17, 2021 | |
| NEBIVOLOL HYDROCHLORIDE×4 | REYOUNG | ANDA 212917 | AB | Dec 17, 2021 | |
| NEBIVOLOL HYDROCHLORIDE×4 | HETERO LABS LTD III | ANDA 203825 | AB | Nov 03, 2020 | |
| NEBIVOLOL HYDROCHLORIDE×4 | TORRENT | ANDA 203966 | — | Mar 02, 2018 | |
| NEBIVOLOL HYDROCHLORIDE×4 | GLENMARK PHARMS LTD | ANDA 203821 | AB | May 25, 2017 | |
| NEBIVOLOL HYDROCHLORIDE×4 | WATSON LABS INC | ANDA 203683 | — | Nov 27, 2015 | |
| NEBIVOLOL HYDROCHLORIDE×4 | INDCHEMIE HEALTH | ANDA 203828 | AB | Jul 29, 2015 | |
| NEBIVOLOL HYDROCHLORIDE×4 | ALKEM LABS LTD | ANDA 203741 | — | Jun 24, 2015 | |
| NEBIVOLOL HYDROCHLORIDE×4 | ANI PHARMS | ANDA 203659 | AB | Apr 16, 2015 |
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.
Nebivolol hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
