Generic Companies with Tentative Approvals for: Zydus Worldwide Dmcc
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Zydus Worldwide Dmcc 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 |
---|---|---|---|---|
Zydus Worldwide Dmcc | ibrutinib | 214296 | 280MG | TABLET;ORAL |
Zydus Worldwide Dmcc | sitagliptin | 211566 | 25MG | TABLET; ORAL |
Zydus Worldwide Dmcc | ibrutinib | 214296 | 420MG | TABLET;ORAL |
Zydus Worldwide Dmcc | valbenazine tosylate | 216137 | 60MG | CAPSULE;ORAL |
Zydus Worldwide Dmcc | valbenazine tosylate | 216137 | 80MG | CAPSULE;ORAL |
Zydus Worldwide Dmcc | valbenazine tosylate | 216137 | 40MG | CAPSULE;ORAL |
Zydus Worldwide Dmcc | ibrutinib | 214296 | 560MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |