APPLICATION
ANDA202700
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-18
LATEST ACTION
2016-06-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MODAFINILPrescription
MODAFINIL 100MG · TABLET · ORAL
MODAFINILPrescription
MODAFINIL 200MG · TABLET · ORAL
Approval history
2016-06-15Labeling · Supplement 2 · standardAP
2012-10-18UNKNOWN · 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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