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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 213276

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NDA 213276 describes IVABRADINE HYDROCHLORIDE, which is a drug marketed by Annora Pharma, Bionpharma, Ingenus Pharms Llc, and Zydus Pharms, and is included in four NDAs. It is available from five 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. Six 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

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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