Last Updated: November 8, 2026

Details for New Drug Application (NDA): 203454

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NDA 203454 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, 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 203454

Tradename:	GRANISETRON HYDROCHLORIDE
Applicant:	Pharmobedient
Ingredient:	granisetron hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Approval Date:	Apr 4, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date:	Apr 4, 2017	TE:		RLD:	No

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