Application Nr Approved Date Route Status External Links
NDA205831 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Aptensio Xr Is Indicated For The Treatment Of Attention Deficit Hyperactivity Disorder (Adhd ) In Patients 6 Years And Older [ See Clinical Studies (14) ]. Aptensio Xr Is A Central Nervous System (Cns) Stimulant Indicated For The Treatment Of Attention Deficit Hyperactivity Disorder (Adhd) In Patients 6 Years And Older. ( 1 ) Limitations Of Use : Pediatric Patients Younger Than 6 Years Of Age Experienced Higher Plasma Exposure Than Patients 6 Years And Older At The Same Dose And High Rates Of Adverse Reactions, Most Notably Weight Loss. ( 8.4 ) Limitations Of Use Pediatric Patients Younger Than 6 Years Of Age Experienced Higher Plasma Exposure Than Patients 6 Years And Older At The Same Dose And High Rates Of Adverse Reactions, Most Notably Weight Loss [See Use In Specific Populations (8.4) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE ZINC2522648

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