Last Updated: September 24, 2026

Details for New Drug Application (NDA): 078843

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NDA 078843 describes GRANISETRON HYDROCHLORIDE, which is a drug marketed by Am Regent, Amneal, Baxter Hlthcare Corp, Bionpharma, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Mylan Asi, Pharmobedient, Rising, Sandoz, Sandoz Inc, Teva Pharms Usa, Wockhardt Usa, Yung Shin Pharm, Intra Sana Labs, Apotex Inc, Aurobindo Pharma Usa, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Natco Pharma, Orbion Pharms, Taro, and Teva Pharms, and is included in forty-seven NDAs. It is available from seven suppliers. Additional details are available on the GRANISETRON HYDROCHLORIDE profile page.

The generic ingredient in GRANISETRON HYDROCHLORIDE is granisetron hydrochloride. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.

Summary for 078843

Tradename:	GRANISETRON HYDROCHLORIDE
Applicant:	Apotex Inc
Ingredient:	granisetron hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Feb 27, 2008	TE:		RLD:	No

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