FDA Approved: DAPAGLIFLOZIN — Original Application (Alembic Pharmaceuticals Limited)

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Summary

FDA approved Alembic Pharmaceuticals Limited's original ANDA for dapagliflozin, enabling a generic version of the diabetes medication to reach the market.

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Diseases / indications

• Chronic Kidney Disease
• Heart Failure
• Type 2 Diabetes Mellitus

Drugs mentioned

• Dapagliflozin (dapagliflozin)

Snippet

ORIG AP for DAPAGLIFLOZIN (DAPAGLIFLOZIN)