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Last Updated: February 3, 2023

Generic Companies with Tentative Approvals for: bendamustine

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bendamustine 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
Dr Reddys Labs Ltd	bendamustine hydrochloride	215668	100MG/4ML (25MG/ML)	SOLUTION;INTRAVENOUS
Eugia Pharma Speclts	bendamustine hydrochloride	214739	100MG/VIAL	POWDER;IV (INFUSION)
Mylan Labs Ltd	bendamustine hydrochloride	204104	25MG/VIAL	POWDER;IV (INFUSION)
Hospira Inc	bendamustine hydrochloride	204086	25MG/VIAL	POWDER;IV (INFUSION)
Celerity Pharms	bendamustine hydrochloride	209814	25MG/VIAL	POWDER;IV (INFUSION)
Mylan Labs Ltd	bendamustine hydrochloride	204104	100MG/VIAL	POWDER;IV (INFUSION)
Innopharma Licensing	bendamustine hydrochloride	205476	25MG/VIAL	POWDER;IV (INFUSION)
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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Serving leading biopharmaceutical companies globally:

Colorcon

Johnson and Johnson

Dow

Mallinckrodt

Baxter

Harvard Business School

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