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RIVAROXABAN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2025-06-26

Drug application

FDA Application #

ANDA218502

Application type

Abbreviated New Drug Application (Generic)

Brand name

RIVAROXABAN

Generic name

RIVAROXABAN

Active ingredients

RIVAROXABAN

Dosage form

FOR SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

ALKEM LABS LTD

Manufacturer

Ascend Laboratories, LLC

First approval

2025-06-26

Source

Authoritative

Drugs@FDA application overview

Machine

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