Application Nr Approved Date Route Status External Links
ANDA209966 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Modafinil Tablets Are Indicated To Improve Wakefulness In Adult Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea (osa), Or Shift Work Disorder (swd). Limitations Of Use In Osa, Modafinil Is Indicated To Treat Excessive Sleepiness And Not As Treatment For The Underlying Obstruction. If Continuous Positive Airway Pressure (cpap) Is The Treatment Of Choice For A Patient, A Maximal Effort To Treat With Cpap For An Adequate Period Of Time Should Be Made Prior To Initiating And During Treatment With Modafinil For Excessive Sleepiness. Modafinil Tablets Are Indicated To Improve Wakefulness In Adult Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea (osa), Or Shift Work Disorder (swd). ( 1 ) Limitations Of Use In Osa, Modafinil Tablets Are Indicated To Treat Excessive Sleepiness And Not As Treatment For The Underlying Obstruction.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Modafinil MODAFINIL ZINC3831139

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