APPLICATION
ANDA214196
TYPE
ANDA
ORIGINAL APPROVAL
2021-06-14
LATEST ACTION
2021-06-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
ETRAVIRINEPrescription
ETRAVIRINE 200MG · TABLET · ORAL
ETRAVIRINEDiscontinued
ETRAVIRINE 25MG · TABLET · ORAL
ETRAVIRINEPrescription
ETRAVIRINE 100MG · TABLET · ORAL
Approval history
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.