FDA Tentative Approval: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

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Summary

FDA issued tentative approval for Sun Pharmaceutical's generic dapagliflozin and metformin hydrochloride tablet (ANDA 211491), enabling potential market entry s…

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Diseases / indications

• Type 2 Diabetes Mellitus

Drugs mentioned

• Dapagliflozin and metformin hydrochloride (dapagliflozin and metformin hydrochloride)

Snippet

ORIG TA for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE)