← FDA DRUG APPROVALS

FDA ANDA · ANDA208544

RIVAROXABAN

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA208544
TYPE
ANDA
ORIGINAL APPROVAL
2025-04-10
LATEST ACTION
2025-05-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

RIVAROXABANPrescription
RIVAROXABAN 15MG · TABLET · ORAL
RIVAROXABANPrescription
RIVAROXABAN 2.5MG · TABLET · ORAL
RIVAROXABANPrescription
RIVAROXABAN 20MG · TABLET · ORAL
RIVAROXABANPrescription
RIVAROXABAN 10MG · TABLET · ORAL

Approval history

2025-05-15UNKNOWN · Original · standardAP
2025-04-10UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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