Application Nr Approved Date Route Status External Links
ANDA200751 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Armodafinil Tablets Are Indicated To Improve Wakefulness In Adult Patients With Excessive Sleepiness Associated With Obstructive Sleep Apnea (osa), Narcolepsy, Or Shift Work Disorder (swd). ( 1 ) Limitations Of Use In Osa, Armodafinil Tablets Are Indicated To Treat Excessive Sleepiness And Not As Treatment For The Underlying Obstruction. Armodafinil Tablets Are Indicated To Improve Wakefulness In Adult Patients With Excessive Sleepiness Associated With Obstructive Sleep Apnea (osa), Narcolepsy, Or Shift Work Disorder (swd). Limitations Of Use In Osa, Armodafinil Tablets Are 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 Armodafinil Tablets For Excessive Sleepiness.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Armodafinil ARMODAFINIL ZINC3831139

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