FDA Approved: DABIGATRAN ETEXILATE — Original Application (XLCare Pharmaceuticals, Inc.)

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Summary

FDA approved the original application for a generic dabigatran etexilate (ANDA 207961) from XLCare Pharmaceuticals, confirming the generic’s established oral an…

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Diseases / indications

• Deep Vein Thrombosis
• Nonvalvular Atrial Fibrillation
• Pulmonary Embolism

Drugs mentioned

• Dabigatran etexilate (Dabigatran etexilate)

Snippet

ORIG AP for DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)