Generic Companies with Tentative Approvals for: empagliflozin;linagliptin;metformin hydrochloride
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empagliflozin;linagliptin;metformin hydrochloride 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 Pharms Usa Inc | empagliflozin;linagliptin;metformin hydrochloride | 217049 | 5MG;2.5MG;1000MG | TABLET, EXTENDED RELEASE;ORAL |
Zydus Pharms Usa Inc | empagliflozin;linagliptin;metformin hydrochloride | 217049 | 12.5MG;2.5MG;1000MG | TABLET, EXTENDED RELEASE;ORAL |
Zydus Pharms Usa Inc | empagliflozin;linagliptin;metformin hydrochloride | 217049 | 10MG;5MG;1000MG | TABLET, EXTENDED RELEASE;ORAL |
Zydus Pharms Usa Inc | empagliflozin;linagliptin;metformin hydrochloride | 217049 | 25MG;5MG;1000MG | TABLET, EXTENDED RELEASE;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |