APPLICATION
ANDA077667
TYPE
ANDA
ORIGINAL APPROVAL
2014-02-03
LATEST ACTION
2023-06-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MODAFINILPrescription
MODAFINIL 100MG · TABLET · ORAL
MODAFINILPrescription
MODAFINIL 200MG · TABLET · ORAL
Approval history
2023-06-21Labeling · Supplement 10 · standardAP
2021-05-11Labeling · Supplement 4 · standardAP
2021-05-11Labeling · Supplement 3 · standardAP
2014-02-03OriginalAP
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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