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Last Updated: December 2, 2022

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.

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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Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
Medtronic
Colorcon
Mallinckrodt
Baxter

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