Orange Book product · Generic (ANDA)
IVABRADINE HYDROCHLORIDE
IVABRADINE HYDROCHLORIDE
At a glance
Nov 29, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 29, 2023
2 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
IVABRADINE HYDROCHLORIDE
Strength
EQ 5MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 213442
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of IVABRADINE HYDROCHLORIDE
- 2015CORLANORBrand (NDA)
NDA 206143 · AMGEN INC
- 2025IVABRADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213483 · MSN
- 2024IVABRADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215238 · ALEMBIC
- 2024IVABRADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213276 · BIONPHARMA
- 2022IVABRADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213366 · ANNORA PHARMA
- 2021IVABRADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214051 · INGENUS PHARMS LLC
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.
