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FDA ANDA · ANDA076594

MODAFINIL

Sponsor: NATCO PHARMA

APPLICATION
ANDA076594
TYPE
ANDA
ORIGINAL APPROVAL
2012-07-16
LATEST ACTION
2015-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MODAFINILDiscontinued
MODAFINIL 200MG · TABLET · ORAL
MODAFINILDiscontinued
MODAFINIL 100MG · TABLET · ORAL

Approval history

2015-12-01Labeling · Supplement 4 · standardAP
2014-10-20Manufacturing (CMC) · Supplement 1 · unknownAP
2012-07-16OriginalAP
VIEW ON DRUGS@FDA ↗

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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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