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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213442
Company: ZYDUS PHARMS

Products on ANDA 213442

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 213442

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213442

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	213276	BIONPHARMA
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	213276	BIONPHARMA
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

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