Generic Companies with Tentative Approvals for: palonosetron hydrochloride

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palonosetron hydrochloride Generic Filers with Tentative Approvals

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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Applicant	Generic Name	NDA	Strength	Dosage Form
Teva Pharms Usa	palonosetron hydrochloride	090713	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE;INTRAVENOUS
Teva Pharms Usa	palonosetron hydrochloride	090713	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE;INTRAVENOUS
Fresenius Kabi Usa	palonosetron hydrochloride	208109	0.25MG/5ML	INJECTABLE;INJECTION
Aurobindo Pharma Ltd	palonosetron hydrochloride	204702	0.25MG/5ML	INJECTABLE;INJECTION
Akorn Inc	palonosetron hydrochloride	204731	0.25MG(BASE)/5ML	INJECTABLE;INJECTION
Applicant	Generic Name	NDA	Strength	Dosage Form

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