Orange Book product · Generic (ANDA)
NEBIVOLOL HYDROCHLORIDE
NEBIVOLOL HYDROCHLORIDE
At a glance
Jan 28, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 28, 2025
1 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
NEBIVOLOL HYDROCHLORIDE
Strength
EQ 2.5MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 212661
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NEBIVOLOL HYDROCHLORIDE
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ANDA 212682 · PRINSTON INC
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ANDA 213349 · CHARTWELL RX
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ANDA 213830 · UNICHEM
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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.
