← FDA DRUG APPROVALS

FDA NDA · NDA219016

EDURANT PED

rilpivirine hydrochloride

Sponsor: JANSSEN PRODS

APPLICATION
NDA219016
TYPE
NDA
ORIGINAL APPROVAL
2024-03-15
LATEST ACTION
2024-03-15
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription

Products

EDURANT PED · ReferencePrescription
RILPIVIRINE HYDROCHLORIDE EQ 2.5MG BASE · TABLET, FOR SUSPENSION · ORAL

Approval history

2024-03-15Type 3 - New Dosage Form · Original · priority — Letter ↗AP
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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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