Orange Book product · Brand (NDA)
BYSTOLIC
NEBIVOLOL HYDROCHLORIDE
At a glance
Dec 17, 2007
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 17, 2007
18 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
NEBIVOLOL HYDROCHLORIDE
Strength
EQ 2.5MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021742
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025NEBIVOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 212661 · MACLEODS PHARMS LTD
- 2024NEBIVOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 217397 · MSN
- 2024NEBIVOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 209741 · APOTEX
- 2023NEBIVOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 216568 · REGCON HOLDINGS
- 2022NEBIVOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 216172 · MANKIND PHARMA
- 2022NEBIVOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 212682 · PRINSTON INC
- 2022NEBIVOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 213349 · CHARTWELL RX
- 2022NEBIVOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 213830 · UNICHEM
- 2021NEBIVOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 211053 · AUROBINDO PHARMA LTD
- 2021NEBIVOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 208717 · CADILA PHARMS LTD
- 2021NEBIVOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 212917 · REYOUNG
- 2020NEBIVOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 203825 · HETERO LABS LTD III
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.
