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Last Updated: February 4, 2023

Generic Companies with Tentative Approvals for: ibrutinib


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ibrutinib 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
Alvogen Inc ibrutinib 214498 70MG CAPSULE;ORAL
Alvogen Pine Brook ibrutinib 212763 560MG TABLET;ORAL
Teva Pharms Usa Inc ibrutinib 211350 140MG CAPSULE;ORAL
Alvogen Pine Brook ibrutinib 212763 420MG TABLET;ORAL
Zydus Worldwide Dmcc ibrutinib 214296 560MG TABLET;ORAL
Alvogen Pine Brook ibrutinib 212763 280MG TABLET;ORAL
>Applicant >Generic Name >NDA >Strength >Dosage Form

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Serving leading biopharmaceutical companies globally:

Merck
Baxter
AstraZeneca
Johnson and Johnson
Boehringer Ingelheim
Medtronic

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