FDA Approved: DABIGATRAN — Original Application (Novadoz Pharmaceuticals LLC)

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Summary

FDA approved the original ANDA (ANDA213879) for DABIGATRAN (Dabigatan etexilate), a generic anticoagulant. The approval enables Novadoz Pharmaceuticals LLC to m…

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Diseases / indications

• Deep Vein Thrombosis
• Nonvalvular Atrial Fibrillation
• Pulmonary Embolism

Drugs mentioned

• Dabigatran (Dabigatran etexilate)

Snippet

ORIG AP for DABIGATRAN (DABIGATRAN ETEXILATE)