APPLICATION
ANDA200156
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-29
LATEST ACTION
2017-01-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval), Discontinued
Products
ARMODAFINILNone (Tentative Approval)
ARMODAFINIL 2500MG · TABLET · ORAL
ARMODAFINILNone (Tentative Approval)
ARMODAFINIL 150MG · TABLET · ORAL
ARMODAFINILNone (Tentative Approval)
ARMODAFINIL 50MG · TABLET · ORAL
ARMODAFINILDiscontinued
ARMODAFINIL 200MG · TABLET · ORAL
ARMODAFINILDiscontinued
ARMODAFINIL 100MG · TABLET · ORAL
Approval history
2017-01-25Labeling · Supplement 1 · standardAP
2012-08-29Not Applicable · OriginalTA
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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