APPLICATION
ANDA218798
TYPE
ANDA
ORIGINAL APPROVAL
2026-01-29
LATEST ACTION
2026-01-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, None (Tentative Approval)
Products
RILPIVIRINE HYDROCHLORIDEPrescription
RILPIVIRINE HYDROCHLORIDE EQ 25MG BASE · TABLET · ORAL
RILPIVIRINENone (Tentative Approval)
RILPIVIRINE 2.5MG · TABLET
Approval history
2026-01-29UNKNOWN · Original · standardAP
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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