FDA Approved: XARELTO — Original Application (Janssen Pharmaceuticals, Inc.)

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Summary

This FDA record documents the original approval of XARELTO (rivaroxaban) under NDA 215859, establishing its initial indication as an anticoagulant for nonvalvul…

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Diseases / indications

• Nonvalvular Atrial Fibrillation

Drugs mentioned

• Xarelto (rivaroxaban)

Snippet

ORIG AP for XARELTO (RIVAROXABAN)