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RIVAROXABAN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN · Approved 2025-09-25

Drug application

FDA Application #

ANDA218195

Application type

Abbreviated New Drug Application (Generic)

Brand name

RIVAROXABAN

Generic name

RIVAROXABAN GRANULE

Active ingredients

RIVAROXABAN

Dosage form

FOR SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

LUPIN

Manufacturer

Lupin Pharmaceuticals, Inc.

First approval

2025-09-25

Source

Authoritative

Drugs@FDA application overview

Machine

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