lurasidone Oral Tablet

Brand(s)
Latuda
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sunovion Pharmaceuticals Inc. (2013-07-18)
Oldest Current Product
2010-10-28
License(s)
NDA
RxNORM
ORAL TABLET\LURASIDONE
FDAOB
ORAL\TABLET\LURASIDONE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\LURASIDONE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\LURASIDONE

product(s) by strength(s)

lurasidone hydrochloride 120 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634020312LatudaNDASunovion Pharmaceuticals Inc.2012-04-26LURASIDONE HYDROCHLORIDEORALTABLET, FILM COATEDNDA200603afad3051-9df2-4c54-9684-e8262a133af8

lurasidone hydrochloride 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634020302LatudaNDASunovion Pharmaceuticals Inc.2011-12-07LURASIDONE HYDROCHLORIDEORALTABLET, FILM COATEDNDA200603afad3051-9df2-4c54-9684-e8262a133af8

lurasidone hydrochloride 40 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634020304LatudaNDASunovion Pharmaceuticals Inc.2010-10-28LURASIDONE HYDROCHLORIDEORALTABLET, FILM COATEDNDA200603afad3051-9df2-4c54-9684-e8262a133af8

lurasidone hydrochloride 60 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634020306LatudaNDASunovion Pharmaceuticals Inc.2013-07-12LURASIDONE HYDROCHLORIDEORALTABLET, FILM COATEDNDA200603afad3051-9df2-4c54-9684-e8262a133af8

lurasidone hydrochloride 80 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634020308LatudaNDASunovion Pharmaceuticals Inc.2010-10-28LURASIDONE HYDROCHLORIDEORALTABLET, FILM COATEDNDA200603afad3051-9df2-4c54-9684-e8262a133af8

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA200603LATUDASUNOVION PHARMACEUTICALS INC2010-10-28p8883794, SUBSTANCE
p8729085, SUBSTANCE
pRE45573
p5532372
INCREASING MAXIMUM DOSING OF PATIENTS WITH SCHIZOPHRENIA TO 160 MG/DAY [2015-04-26]
NEW CHEMICAL ENTITY [2015-10-28]
TREATMENT OF PATIENTS WITH DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) AS MONOTHERAPY AND AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE [2016-06-28]
NDA200603_001, NDA200603_002, NDA200603_003, NDA200603_004, NDA200603_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA200603_001RXLURASIDONE HYDROCHLORIDE (40MG)ORALTABLETTrue2010-10-28LATUDA
2NDA200603_002RXLURASIDONE HYDROCHLORIDE (80MG)ORALTABLETFalse2010-10-28LATUDA
3NDA200603_003RXLURASIDONE HYDROCHLORIDE (20MG)ORALTABLETFalse2011-12-07LATUDA
4NDA200603_004RXLURASIDONE HYDROCHLORIDE (120MG)ORALTABLETFalse2012-04-26LATUDA
5NDA200603_005RXLURASIDONE HYDROCHLORIDE (60MG)ORALTABLETFalse2013-07-12LATUDA

patent(s)

#idexpiration dateapplication(s)
1p5532372 (view patent)2018-07-02NDA200603
2p8729085 (view patent)2026-05-26NDA200603
3p8883794 (view patent)2026-05-26NDA200603
4pRE45573 (view patent)2025-06-23NDA200603

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
188a244d1-eddb-499c-bee2-e1f49056e78f (view SPL)These highlights do not include all the information needed to use LATUDA safely and effectively. See full prescribing information for LATUDA.LATUDA (LURASIDONE HCL) tablets for oral administration, Initial U.S. Approval: 2010prescriptionHuman PrescriptionBushu Pharmaceutical, Ltd.ANALYSIS, LABEL, MANUFACTURE, PACK2010-11-181511480001, 511480002
2afad3051-9df2-4c54-9684-e8262a133af8 (view SPL)These highlights do not include all the information needed to use LATUDA safely and effectively. See full prescribing information for LATUDA.LATUDA (lurasidone hydrochloride) tablets, for oral use Initial U.S. Approval: 2010prescriptionHuman PrescriptionSunovion Pharmaceuticals Inc.2013-07-1815634020302, 634020304, 634020306, 634020308, 634020312

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