FDA Tentative Approval: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — Supplemental Application (Prasco Laboratories)

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Summary

FDA issued tentative approval for a generic fixed-dose combination of dapagliflozin and metformin hydrochloride, manufactured by Prasco Laboratories, under a su…

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Diseases / indications

• Type 2 Diabetes Mellitus

Drugs mentioned

• Dapagliflozin and metformin hydrochloride (dapagliflozin and metformin hydrochloride)

Snippet

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