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RILPIVIRINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SOMERSET THERAPS LLC · Approved 2026-01-29

Drug application

FDA Application #

ANDA218798

Application type

Abbreviated New Drug Application (Generic)

Brand name

RILPIVIRINE HYDROCHLORIDE

Generic name

RILPIVIRINE

Active ingredients

RILPIVIRINE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

SOMERSET THERAPS LLC

Manufacturer

Somerset Therapeutics, LLC

First approval

2026-01-29

Source

Authoritative

Drugs@FDA application overview

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