Generic Companies with Tentative Approvals for: Zydus
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Zydus 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 Pharms Usa Inc | metformin hydrochloride;sitagliptin phosphate | 208535 | 50MG/500MG;50MG/1000MG | TABLET;ORAL |
| Zydus Pharms Usa Inc | empagliflozin;linagliptin;metformin hydrochloride | 217049 | 5MG;2.5MG;1000MG | TABLET, EXTENDED RELEASE;ORAL |
| >Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |
