APPLICATION
ANDA200751
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-28
LATEST ACTION
2017-07-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, None (Tentative Approval)
Products
ARMODAFINILDiscontinued
ARMODAFINIL 200MG · TABLET · ORAL
ARMODAFINILNone (Tentative Approval)
ARMODAFINIL 100MG · TABLET · ORAL
ARMODAFINILDiscontinued
ARMODAFINIL 250MG · TABLET · ORAL
ARMODAFINILDiscontinued
ARMODAFINIL 150MG · TABLET · ORAL
ARMODAFINILDiscontinued
ARMODAFINIL 50MG · TABLET · ORAL
Approval history
2017-07-14Labeling · Supplement 2 · standardAP
2017-07-14Manufacturing (CMC) · Supplement 3 · unknownAP
2016-11-28Not Applicable · OriginalTA
2016-11-28Not Applicable · OriginalAP
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.