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FDA ANDA · ANDA218502

RIVAROXABAN

Sponsor: ALKEM LABS LTD

APPLICATION
ANDA218502
TYPE
ANDA
ORIGINAL APPROVAL
2025-06-26
LATEST ACTION
2025-06-26
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

RIVAROXABANPrescription
RIVAROXABAN 1MG/ML · FOR SUSPENSION · ORAL

Approval history

2025-06-26UNKNOWN · Original · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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