APPLICATION
ANDA202566
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-27
LATEST ACTION
2020-12-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MODAFINILPrescription
MODAFINIL 200MG · TABLET · ORAL
MODAFINILPrescription
MODAFINIL 100MG · TABLET · ORAL
Approval history
2020-12-18Labeling · Supplement 5 · standardAP
2014-11-05Manufacturing (CMC) · Supplement 3 · unknownAP
2012-09-27UNKNOWN · 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.
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