An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 214051
Company: INGENUS PHARMS LLC

Products on ANDA 214051

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	AB	No	No
IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214051

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214051Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 214051

IVABRADINE HYDROCHLORIDE

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CORLANOR	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	Yes	AB	206143	AMGEN INC
IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	213366	ANNORA PHARMA
IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	214051	INGENUS PHARMS LLC
IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	213442	ZYDUS PHARMS

TABLET;ORAL; EQ 7.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CORLANOR	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET;ORAL	Prescription	Yes	AB	206143	AMGEN INC
IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET;ORAL	Prescription	No	AB	213366	ANNORA PHARMA
IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET;ORAL	Prescription	No	AB	214051	INGENUS PHARMS LLC
IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET;ORAL	Prescription	No	AB	213442	ZYDUS PHARMS

Top