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EDURANT PED

NDA · New Drug Application · Sponsor: JANSSEN PRODS · Approved 2024-03-15

Drug application

FDA Application #

NDA219016

Application type

New Drug Application

Brand name

EDURANT PED

Generic name

RILPIVIRINE HYDROCHLORIDE

Active ingredients

RILPIVIRINE HYDROCHLORIDE

Dosage form

TABLET, FOR SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

JANSSEN PRODS

Manufacturer

Janssen Products, LP

First approval

2024-03-15

Source

Authoritative

Drugs@FDA application overview

Machine

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