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ABILIFY MYCITE KIT (nda207202)- (2MG,5MG,10MG,15MG,20MG,30MG)

ARIPIPRAZOLE OTSUKA
2MG,5MG,10MG,15MG,20MG,30MG
No No
2034-Sep-19 Expired
None None
None No
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 • Treatment of bipolar I disorder o Acute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate o Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate • Adjunctive treatment of adults with major depressive disorder (MDD)
0 0 0
Total Other Developers None
Drugs with Suitability No
2MG ** ** - - -
5MG ** ** - - -
10MG ** ** - - -
15MG ** ** - - -
20MG ** ** - - -
30MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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