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Last Updated: October 1, 2020

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Generic Companies with Tentative Approvals for: dapagliflozin; metformin hydrochloride

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dapagliflozin; 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
Astrazeneca Ab dapagliflozin; metformin hydrochloride 205649 5MG;1GM TABLET, EXTENDED RELEASE;ORAL
Astrazeneca Ab dapagliflozin; metformin hydrochloride 205649 10MG;500MG TABLET, EXTENDED RELEASE;ORAL
Astrazeneca Ab dapagliflozin; metformin hydrochloride 205649 10MG;1GM TABLET, EXTENDED RELEASE;ORAL
Astrazeneca Ab dapagliflozin; metformin hydrochloride 205649 5MG;500MG TABLET, EXTENDED RELEASE;ORAL
Astrazeneca Ab dapagliflozin; metformin hydrochloride 205649 2.5MG;1GM TABLET, EXTENDED RELEASE;ORAL
>Applicant >Generic Name >NDA >Strength >Dosage Form

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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Mallinckrodt
McKesson
Moodys
Baxter

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