Last Updated: November 8, 2026

Details for New Drug Application (NDA): 077177

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NDA 077177 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 077177

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date:	Dec 31, 2007	TE:	AP	RLD:	No

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