Application Nr Approved Date Route Status External Links
NDA207202 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Abilify Mycite, A Drug-Device Combination Product Comprised Of Aripiprazole Tablets Embedded With An Ingestible Event Marker (Iem) Sensor Intended To Track Drug Ingestion, Is Indicated For The: Treatment Of Adults With Schizophrenia [See Clinical Studies (14.1) ] Treatment Of Bipolar I Disorder Acute Treatment Of Adults With Manic And Mixed Episodes As Monotherapy And As Adjunct To Lithium Or Valproate [See Clinical Studies (14.2) ] Maintenance Treatment Of Adults As Monotherapy And As Adjunct To Lithium Or Valproate [See Clinical Studies (14.2) ] Adjunctive Treatment Of Adults With Major Depressive Disorder [See Clinical Studies (14.3) ] Abilify Mycite, A Drug-Device Combination Product Comprised Of Aripiprazole Tablets Embedded With An Ingestible Event Marker (Iem) Sensor Intended To Track Drug Ingestion, Is Indicated For The: Treatment Of Adults With Schizophrenia ( 1 ) Treatment Of Bipolar I Disorder ( 1 ) Acute Treatment Of Adults With Manic And Mixed Episodes As Monotherapy And As Adjunct To Lithium Or Valproate Maintenance Treatment Of Adults As Monotherapy And As Adjunct To Lithium Or Valproate Adjunctive Treatment Of Adults With Major Depressive Disorder (Mdd) ( 1 ) Limitations Of Use : The Ability Of Abilify Mycite To Improve Patient Compliance Or Modify Aripiprazole Dosage Has Not Been Established. ( 1 ) The Use Of Abilify Mycite To Track Drug Ingestion In "real-Time" Or During An Emergency Is Not Recommended Because Detection May Be Delayed Or Not Occur. ( 1 ) Limitations Of Use : The Ability Of The Abilify Mycite To Improve Patient Compliance Or Modify Aripiprazole Dosage Has Not Been Established [See Dosage And Administration (2.1) ] . The Use Of Abilify Mycite To Track Drug Ingestion In "real-Time" Or During An Emergency Is Not Recommended Because Detection May Be Delayed Or Not Occur [See Dosage And Administration (2.1) ] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Aripiprazole ARIPIPRAZOLE ZINC1851149

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