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Last Updated: October 1, 2020

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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
Breckenridge Pharm	bendamustine hydrochloride	205447	100MG/VIAL	POWDER;IV (INFUSION)
Celerity Pharms	bendamustine hydrochloride	209814	100MG/VIAL	POWDER;IV (INFUSION)
Slayback Pharma Llc	bendamustine hydrochloride	212209	100 mg/m2	INJECTABLE;INJECTION
Breckenridge Pharm	bendamustine hydrochloride	205447	25MG/VIAL	POWDER;IV (INFUSION)
Hospira	bendamustine	211530	100MG/4ML	SOLUTION;IV (INFUSION)
Glenmark Pharms Ltd	bendamustine hydrochloride	204771	100MG/VIAL	POWDER;IV (INFUSION)
Mylan Labs Ltd	bendamustine hydrochloride	204104	100MG/VIAL	POWDER;IV (INFUSION)
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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Colorcon

Johnson and Johnson

Dow

Mallinckrodt

Baxter

Harvard Business School

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