Generic Companies with Tentative Approvals for: Breckenridge

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Breckenridge 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)
Breckenridge Pharm	bendamustine hydrochloride	205447	25MG/VIAL	POWDER;IV (INFUSION)
Breckenridge Pharms	tofacitinib	209633	5MG	TABLET;ORAL
Breckenridge Pharms	dabigatran etexilate mesylate	207922	110MG	CAPSULE;ORAL
Breckenridge	carfilzomib	209330	60MG/VIAL	POWDER;INTRAVENOUS
Breckenridge Pharms	dabigatran etexilate mesylate	207922	150MG	CAPSULE;ORAL
Breckenridge Pharms	sodium sulfate;potassium sulfate;magnesium sulfate	204135	17.5G;3.13G;1.6G	SOLUTION;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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