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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 213276

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NDA 213276 describes IVABRADINE HYDROCHLORIDE, which is a drug marketed by Alembic, Annora Pharma, Bionpharma, Ingenus Pharms Llc, MSN, and Zydus Pharms, and is included in six NDAs. It is available from ten suppliers. Additional details are available on the IVABRADINE HYDROCHLORIDE profile page.

The generic ingredient in IVABRADINE HYDROCHLORIDE is ivabradine hydrochloride. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the ivabradine hydrochloride profile page.

Summary for 213276

Tradename:	IVABRADINE HYDROCHLORIDE
Applicant:	Bionpharma
Ingredient:	ivabradine hydrochloride
Patents:	0

Pharmacology for NDA: 213276

Mechanism of Action	Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists

Suppliers and Packaging for NDA: 213276

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213276	ANDA	Bionpharma Inc.	69452-190	69452-190-17	60 TABLET, FILM COATED in 1 BOTTLE (69452-190-17)
IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213276	ANDA	Bionpharma Inc.	69452-190	69452-190-30	500 TABLET, FILM COATED in 1 BOTTLE (69452-190-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Sep 5, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 7.5MG BASE
Approval Date:	Sep 5, 2024	TE:	AB	RLD:	No

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