aripiprazole lauroxil Prefilled Syringe

Brand(s)
Aristada
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alkermes, Inc. (2015-09-12)
Oldest Current Product
2015-10-05
License(s)
NDA
RxNORM
PREFILLED SYRINGE\ARIPIPRAZOLE LAUROXIL
FDAOB
INTRAMUSCULAR\SUSPENSION, EXTENDED RELEASE\ARIPIPRAZOLE LAUROXIL
SPL Active
INTRAMUSCULAR\INJECTION, SUSPENSION, EXTENDED RELEASE\ARIPIPRAZOLE LAUROXIL
SPL Moiety
INTRAMUSCULAR\INJECTION, SUSPENSION, EXTENDED RELEASE\ARIPIPRAZOLE LAUROXIL

product(s) by strength(s)

3.2 ml aripiprazole lauroxil 276 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1657570403AristadaNDAAlkermes, Inc.2015-10-05ARIPIPRAZOLE LAUROXILINTRAMUSCULARINJECTION, SUSPENSION, EXTENDED RELEASENDA20753317a8d11b-73b0-4833-a0b4-cf1ef85edefb

2.4 ml aripiprazole lauroxil 276 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1657570402AristadaNDAAlkermes, Inc.2015-10-05ARIPIPRAZOLE LAUROXILINTRAMUSCULARINJECTION, SUSPENSION, EXTENDED RELEASENDA20753317a8d11b-73b0-4833-a0b4-cf1ef85edefb

1.6 ml aripiprazole lauroxil 276 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1657570401AristadaNDAAlkermes, Inc.2015-10-05ARIPIPRAZOLE LAUROXILINTRAMUSCULARINJECTION, SUSPENSION, EXTENDED RELEASENDA20753317a8d11b-73b0-4833-a0b4-cf1ef85edefb

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA207533ARISTADAALKERMES INC2015-10-05p8796276, TREATMENT OF SCHIZOPHRENIA
p8431576
p9034867, TREATMENT OF SCHIZOPHRENIA, SUBSTANCE
NEW CHEMICAL ENTITY [2020-10-05]NDA207533_001, NDA207533_002, NDA207533_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA207533_001RXARIPIPRAZOLE LAUROXIL (441MG/1.6ML)INTRAMUSCULARSUSPENSION, EXTENDED RELEASEFalse2015-10-05ARISTADA
2NDA207533_002RXARIPIPRAZOLE LAUROXIL (662MG/2.4ML)INTRAMUSCULARSUSPENSION, EXTENDED RELEASEFalse2015-10-05ARISTADA
3NDA207533_003RXARIPIPRAZOLE LAUROXIL (882MG/3.2ML)INTRAMUSCULARSUSPENSION, EXTENDED RELEASETrue2015-10-05ARISTADA

patent(s)

#idexpiration dateapplication(s)
1p8431576 (view patent)2030-10-26NDA207533
2p8796276 (view patent)2030-06-24NDA207533
3p9034867 (view patent)2032-11-07NDA207533

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
117a8d11b-73b0-4833-a0b4-cf1ef85edefb (view SPL)These highlights do not include all the information needed to use ARISTADA safely and effectively. See full prescribing information for ARISTADA.ARISTADA (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular useInitial U.S. Approval: 2015prescriptionHuman PrescriptionAlkermes, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-09-128657570401, 657570402, 657570403

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII