Details for New Drug Application (NDA): 091136

NDA 091136 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, Norvium Bioscience, 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-six NDAs. It is available from six suppliers. Additional details are available on the GRANISETRON HYDROCHLORIDE profile page.

The generic ingredient in GRANISETRON HYDROCHLORIDE is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.

Summary for 091136

Tradename:	GRANISETRON HYDROCHLORIDE
Applicant:	Mylan Asi
Ingredient:	granisetron hydrochloride
Patents:	0

Pharmacology for NDA: 091136

Mechanism of Action

Serotonin 3 Receptor Antagonists

Suppliers and Packaging for NDA: 091136

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	091136	ANDA	Mylan Institutional LLC	67457-863	67457-863-01	1 VIAL in 1 CARTON (67457-863-01) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Approval Date:	Apr 9, 2010	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date:	Apr 9, 2010	TE:	AP	RLD:	No

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