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Last Updated: February 4, 2023

Generic Companies with Tentative Approvals for: empagliflozin;metformin hydrochloride


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empagliflozin;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
Lupin Ltd empagliflozin;metformin hydrochloride 213654 10MG; 1GM TABLET, EXTENDED RELEASE;ORAL
Lupin Ltd empagliflozin;metformin hydrochloride 213654 25MG; 1GM TABLET, EXTENDED RELEASE;ORAL
Lupin Ltd empagliflozin;metformin hydrochloride 213654 5MG; 1GM TABLET, EXTENDED RELEASE;ORAL
Lupin Ltd empagliflozin;metformin hydrochloride 213654 12.5MG; 1GM TABLET, EXTENDED RELEASE;ORAL
>Applicant >Generic Name >NDA >Strength >Dosage Form

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Serving leading biopharmaceutical companies globally:

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Dow

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