lurasidone Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	4168	367514-87-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: SM-13496 latuda lurasidone hydrochloride lurasidone lurasidone HCl	The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear. However, its efficacy in schizophrenia and bipolar depression could be mediated through a combination of central dopamine D2 and serotonin Type 2 (5HT2A) receptor antagonism. Molecular weight: 492.68 Formula: C28H36N4O2S CLOGP: 5.61 LIPINSKI: 1 HAC: 6 HDO: 0 TPSA: 56.75 ALOGS: -4.80 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

SM-13496
latuda
lurasidone hydrochloride
lurasidone
lurasidone HCl

The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear. However, its efficacy in schizophrenia and bipolar depression could be mediated through a combination of central dopamine D2 and serotonin Type 2 (5HT2A) receptor antagonism.

Molecular weight: 492.68
Formula: C28H36N4O2S
CLOGP: 5.61
LIPINSKI: 1
HAC: 6
HDO: 0
TPSA: 56.75
ALOGS: -4.80
ROTB: 5

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
60	mg	O

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Oct. 28, 2010	FDA	SUNOVION PHARMS INC
March 25, 2020	PMDA	Sumitomo Dainippon Pharma Co., Ltd.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Blood prolactin abnormal	851.95	21.72	168	9694	1953	53337251
Anosognosia	828.55	21.72	165	9697	2024	53337180
Sexual dysfunction	816.12	21.72	175	9687	3151	53336053
Disturbance in social behaviour	763.76	21.72	161	9701	2660	53336544
Metabolic disorder	720.48	21.72	173	9689	5254	53333950
Dystonia	626.73	21.72	186	9676	12835	53326369
Personality change	620.93	21.72	157	9705	5920	53333284
Sedation	563.07	21.72	210	9652	29465	53309739
Dyskinesia	541.53	21.72	208	9654	31625	53307579
Suicide attempt	447.95	21.72	217	9645	57951	53281253
Schizophrenia	388.41	21.72	122	9740	10157	53329047
Blood glucose increased	278.90	21.72	175	9687	77186	53262018
Completed suicide	224.26	21.72	193	9669	138008	53201196
Tardive dyskinesia	208.87	21.72	72	9790	7998	53331206
Mania	178.53	21.72	71	9791	11758	53327446
Insurance issue	166.10	21.72	46	9816	2459	53336745
Akathisia	163.45	21.72	61	9801	8510	53330694
Suicidal ideation	117.63	21.72	94	9768	60417	53278787
Blood prolactin increased	92.00	21.72	31	9831	3208	53335996
Psychotic disorder	82.25	21.72	53	9809	24332	53314872
Delusion	77.95	21.72	40	9822	11969	53327235
Condition aggravated	76.53	21.72	169	9693	296965	53042239
Adverse drug reaction	71.11	21.72	67	9795	53558	53285646
Persistent genital arousal disorder	68.15	21.72	15	9847	304	53338900
Bipolar disorder	62.96	21.72	30	9832	7656	53331548
Galactorrhoea	60.31	21.72	24	9838	3971	53335233
Hallucination, auditory	58.95	21.72	33	9829	11740	53327464
Confabulation	51.74	21.72	12	9850	310	53338894
Depression	51.46	21.72	108	9754	182944	53156260
Serotonin syndrome	49.08	21.72	40	9822	26366	53312838
Restlessness	46.92	21.72	40	9822	28047	53311157
Diarrhoea	46.91	21.72	29	9833	625517	52713687
Weight increased	44.46	21.72	109	9753	204458	53134746
Rheumatoid arthritis	43.59	21.72	4	9858	314527	53024677
Off label use	40.98	21.72	184	9678	472028	52867176
Drug ineffective	39.78	21.72	272	9590	816973	52522231
Therapy cessation	37.09	21.72	35	9827	27990	53311214
Arthralgia	36.36	21.72	18	9844	439765	52899439
Extrapyramidal disorder	34.68	21.72	24	9838	12378	53326826
Anxiety	30.86	21.72	93	9769	196611	53142593
Agitation	29.96	21.72	45	9817	58581	53280623
Oculogyric crisis	29.86	21.72	11	9851	1477	53337727
Personality change due to a general medical condition	29.28	21.72	6	9856	85	53339119
Depressed mood	29.05	21.72	35	9827	36929	53302275
Parkinsonism	28.93	21.72	19	9843	8994	53330210
Tremor	28.34	21.72	68	9794	125668	53213536
Catatonia	27.79	21.72	14	9848	4026	53335178
Joint swelling	27.65	21.72	5	9857	234633	53104571
Hyperthermia	27.35	21.72	18	9844	8551	53330653
Hyperprolactinaemia	27.33	21.72	13	9849	3302	53335902
Blood insulin increased	26.54	21.72	6	9856	138	53339066
Mental disorder	25.87	21.72	27	9835	24349	53314855
Hallucination	25.64	21.72	40	9822	53798	53285406
Anaemia	24.92	21.72	10	9852	276708	53062496
Crying	24.24	21.72	25	9837	22237	53316967
Metamyelocyte count increased	23.95	21.72	6	9856	216	53338988
Apnoea	23.86	21.72	16	9846	7837	53331367
Amenorrhoea	23.60	21.72	17	9845	9332	53329872
Anger	23.50	21.72	19	9843	12371	53326833
Urinary tract infection	22.71	21.72	8	9854	239895	53099309
Change in seizure presentation	22.68	21.72	6	9856	269	53338935

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Anosognosia	321.81	28.67	61	4546	756	32508163
Blood prolactin abnormal	292.28	28.67	57	4550	828	32508091
Disturbance in social behaviour	256.36	28.67	57	4550	1608	32507311
Metabolic disorder	212.04	28.67	58	4549	3895	32505024
Dystonia	208.52	28.67	72	4535	10551	32498368
Sexual dysfunction	202.33	28.67	62	4545	6227	32502692
Schizophrenia	197.24	28.67	68	4539	9916	32499003
Dyskinesia	159.05	28.67	74	4533	23529	32485390
Sedation	149.88	28.67	66	4541	18460	32490459
Personality change	146.37	28.67	46	4561	5013	32503906
Akathisia	105.21	28.67	39	4568	6986	32501933
Suicide attempt	92.44	28.67	61	4546	38183	32470736
Psychotic disorder	84.55	28.67	48	4559	22972	32485947
Mania	83.31	28.67	36	4571	9596	32499323
Completed suicide	74.68	28.67	78	4529	92439	32416480
Blood glucose increased	73.33	28.67	66	4541	65175	32443744
Tardive dyskinesia	72.99	28.67	28	4579	5503	32503416
Suicidal ideation	71.44	28.67	52	4555	38031	32470888
Hallucination, auditory	68.22	28.67	32	4575	10318	32498601
Drug ineffective	54.59	28.67	147	4460	383330	32125589
Extrapyramidal disorder	52.45	28.67	28	4579	11867	32497052
Off label use	52.44	28.67	126	4481	306194	32202725
Neuroleptic malignant syndrome	52.43	28.67	32	4575	17463	32491456
Aggression	42.53	28.67	39	4568	39350	32469569
Weight increased	41.46	28.67	55	4552	83608	32425311
Paranoia	38.22	28.67	22	4585	10777	32498142
Agitation	36.97	28.67	43	4564	57193	32451726
Delusion	36.78	28.67	23	4584	13085	32495834
Grandiosity	33.12	28.67	8	4599	325	32508594
Insurance issue	32.31	28.67	10	4597	1032	32507887
Restlessness	29.53	28.67	26	4581	24855	32484064
Tremor	29.35	28.67	46	4561	81231	32427688

Pharmacologic Action:

Source	Code	Description
ATC	N05AE05	NERVOUS SYSTEM PSYCHOLEPTICS ANTIPSYCHOTICS Indole derivatives
FDA EPC	N0000175430	Atypical Antipsychotic
MeSH PA	D018663	Adrenergic Agents
MeSH PA	D058669	Adrenergic alpha-2 Receptor Antagonists
MeSH PA	D000317	Adrenergic alpha-Antagonists
MeSH PA	D018674	Adrenergic Antagonists
MeSH PA	D014150	Antipsychotic Agents
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D015259	Dopamine Agents
MeSH PA	D018492	Dopamine Antagonists
MeSH PA	D065127	Dopamine D2 Receptor Antagonists
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D011619	Psychotropic Drugs
MeSH PA	D058830	Serotonin 5-HT2 Receptor Antagonists
MeSH PA	D018490	Serotonin Agents
MeSH PA	D012702	Serotonin Antagonists
MeSH PA	D014149	Tranquilizing Agents
CHEBI has role	CHEBI:37887	adrenergic receptor blockaders
CHEBI has role	CHEBI:48279	5-hydroxytryptamine antagonists
CHEBI has role	CHEBI:48561	dopamine blocker
CHEBI has role	CHEBI:65191	atypical antipsychotics

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Schizophrenia	indication	58214004	DOID:5419
Bipolar affective disorder, current episode depression	indication	191627008	DOID:3312
Suicidal thoughts	contraindication	6471006
Weight gain finding	contraindication	8943002
Neuroleptic malignant syndrome	contraindication	15244003	DOID:14464
Lowered convulsive threshold	contraindication	19260006
Orthostatic hypotension	contraindication	28651003
Dysphagia	contraindication	40739000
Hyperlipidemia	contraindication	55822004	DOID:1168
Hepatic failure	contraindication	59927004
Diabetes mellitus	contraindication	73211009	DOID:9351
Hyperglycemia	contraindication	80394007	DOID:4195
Leukopenia	contraindication	84828003	DOID:615
Tardive dyskinesia	contraindication	102449007
Seizure disorder	contraindication	128613002
Impaired renal function disorder	contraindication	197663003
Cerebrovascular accident	contraindication	230690007
Disease of liver	contraindication	235856003	DOID:409
Hyperprolactinemia	contraindication	237662005	DOID:12700
Transient ischemic attack	contraindication	266257000	DOID:224
Esophageal dysmotility	contraindication	266434009	DOID:9192
Syncope	contraindication	271594007
Neutropenic disorder	contraindication	303011007	DOID:1227
Senile dementia with psychosis	contraindication	371026009
Cardiovascular event risk	contraindication	395112001

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.38	Basic
pKa2	0.27	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
120MG	LATUDA	SUNOVION PHARMS INC	N200603	April 26, 2012	RX	TABLET	ORAL	9174975	Feb. 20, 2024	TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA
120MG	LATUDA	SUNOVION PHARMS INC	N200603	April 26, 2012	RX	TABLET	ORAL	9815827	Feb. 20, 2024	TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
120MG	LATUDA	SUNOVION PHARMS INC	N200603	April 26, 2012	RX	TABLET	ORAL	9815827	Feb. 20, 2024	TREATMENT OF SCHIZOPHRENIA
20MG	LATUDA	SUNOVION PHARMS INC	N200603	Dec. 7, 2011	RX	TABLET	ORAL	9174975	Feb. 20, 2024	TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA
20MG	LATUDA	SUNOVION PHARMS INC	N200603	Dec. 7, 2011	RX	TABLET	ORAL	9815827	Feb. 20, 2024	TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
20MG	LATUDA	SUNOVION PHARMS INC	N200603	Dec. 7, 2011	RX	TABLET	ORAL	9815827	Feb. 20, 2024	TREATMENT OF SCHIZOPHRENIA
40MG	LATUDA	SUNOVION PHARMS INC	N200603	Oct. 28, 2010	RX	TABLET	ORAL	9174975	Feb. 20, 2024	TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA
40MG	LATUDA	SUNOVION PHARMS INC	N200603	Oct. 28, 2010	RX	TABLET	ORAL	9815827	Feb. 20, 2024	TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
40MG	LATUDA	SUNOVION PHARMS INC	N200603	Oct. 28, 2010	RX	TABLET	ORAL	9815827	Feb. 20, 2024	TREATMENT OF SCHIZOPHRENIA
60MG	LATUDA	SUNOVION PHARMS INC	N200603	July 12, 2013	RX	TABLET	ORAL	9174975	Feb. 20, 2024	TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA
60MG	LATUDA	SUNOVION PHARMS INC	N200603	July 12, 2013	RX	TABLET	ORAL	9815827	Feb. 20, 2024	TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
60MG	LATUDA	SUNOVION PHARMS INC	N200603	July 12, 2013	RX	TABLET	ORAL	9815827	Feb. 20, 2024	TREATMENT OF SCHIZOPHRENIA
80MG	LATUDA	SUNOVION PHARMS INC	N200603	Oct. 28, 2010	RX	TABLET	ORAL	9174975	Feb. 20, 2024	TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA
80MG	LATUDA	SUNOVION PHARMS INC	N200603	Oct. 28, 2010	RX	TABLET	ORAL	9815827	Feb. 20, 2024	TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
80MG	LATUDA	SUNOVION PHARMS INC	N200603	Oct. 28, 2010	RX	TABLET	ORAL	9815827	Feb. 20, 2024	TREATMENT OF SCHIZOPHRENIA
120MG	LATUDA	SUNOVION PHARMS INC	N200603	April 26, 2012	RX	TABLET	ORAL	9555027	May 26, 2026	TREATMENT OF SCHIZOPHRENIA
20MG	LATUDA	SUNOVION PHARMS INC	N200603	Dec. 7, 2011	RX	TABLET	ORAL	9555027	May 26, 2026	TREATMENT OF SCHIZOPHRENIA
40MG	LATUDA	SUNOVION PHARMS INC	N200603	Oct. 28, 2010	RX	TABLET	ORAL	9555027	May 26, 2026	TREATMENT OF SCHIZOPHRENIA
60MG	LATUDA	SUNOVION PHARMS INC	N200603	July 12, 2013	RX	TABLET	ORAL	9555027	May 26, 2026	TREATMENT OF SCHIZOPHRENIA
80MG	LATUDA	SUNOVION PHARMS INC	N200603	Oct. 28, 2010	RX	TABLET	ORAL	9555027	May 26, 2026	TREATMENT OF SCHIZOPHRENIA
120MG	LATUDA	SUNOVION PHARMS INC	N200603	April 26, 2012	RX	TABLET	ORAL	9259423	May 23, 2031	TREATMENT OF SCHIZOPHRENIA OR BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA AND/OR BIPOLAR DISORDER
120MG	LATUDA	SUNOVION PHARMS INC	N200603	April 26, 2012	RX	TABLET	ORAL	9827242	May 23, 2031	TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
120MG	LATUDA	SUNOVION PHARMS INC	N200603	April 26, 2012	RX	TABLET	ORAL	9827242	May 23, 2031	TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA
20MG	LATUDA	SUNOVION PHARMS INC	N200603	Dec. 7, 2011	RX	TABLET	ORAL	9259423	May 23, 2031	TREATMENT OF SCHIZOPHRENIA OR BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA AND/OR BIPOLAR DISORDER
20MG	LATUDA	SUNOVION PHARMS INC	N200603	Dec. 7, 2011	RX	TABLET	ORAL	9827242	May 23, 2031	TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
20MG	LATUDA	SUNOVION PHARMS INC	N200603	Dec. 7, 2011	RX	TABLET	ORAL	9827242	May 23, 2031	TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA
40MG	LATUDA	SUNOVION PHARMS INC	N200603	Oct. 28, 2010	RX	TABLET	ORAL	9259423	May 23, 2031	TREATMENT OF SCHIZOPHRENIA OR BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA AND/OR BIPOLAR DISORDER
40MG	LATUDA	SUNOVION PHARMS INC	N200603	Oct. 28, 2010	RX	TABLET	ORAL	9827242	May 23, 2031	TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
40MG	LATUDA	SUNOVION PHARMS INC	N200603	Oct. 28, 2010	RX	TABLET	ORAL	9827242	May 23, 2031	TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA
60MG	LATUDA	SUNOVION PHARMS INC	N200603	July 12, 2013	RX	TABLET	ORAL	9259423	May 23, 2031	TREATMENT OF SCHIZOPHRENIA OR BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA AND/OR BIPOLAR DISORDER
60MG	LATUDA	SUNOVION PHARMS INC	N200603	July 12, 2013	RX	TABLET	ORAL	9827242	May 23, 2031	TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
60MG	LATUDA	SUNOVION PHARMS INC	N200603	July 12, 2013	RX	TABLET	ORAL	9827242	May 23, 2031	TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA
80MG	LATUDA	SUNOVION PHARMS INC	N200603	Oct. 28, 2010	RX	TABLET	ORAL	9259423	May 23, 2031	TREATMENT OF SCHIZOPHRENIA OR BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA AND/OR BIPOLAR DISORDER
80MG	LATUDA	SUNOVION PHARMS INC	N200603	Oct. 28, 2010	RX	TABLET	ORAL	9827242	May 23, 2031	TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
80MG	LATUDA	SUNOVION PHARMS INC	N200603	Oct. 28, 2010	RX	TABLET	ORAL	9827242	May 23, 2031	TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN	ANTAGONIST	Ki	9.00	DRUG LABEL	DRUG LABEL
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN	ANTAGONIST	Ki	9.33	DRUG LABEL	DRUG LABEL
5-hydroxytryptamine receptor 7	GPCR	P34969	5HT7R_HUMAN	ANTAGONIST	Ki	9.31	DRUG LABEL
Alpha-2C adrenergic receptor	GPCR	P18825	ADA2C_HUMAN		Ki	7.97	DRUG LABEL
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN		Ki	7.39	DRUG LABEL
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN		Ki	8.20	DRUG LABEL
5-hydroxytryptamine receptor 1A	GPCR		5HT1A_RAT	AGONIST	Ki	8.17	IUPHAR
5-hydroxytryptamine receptor 2A	GPCR		5HT2A_RAT	ANTAGONIST	Ki	8.69	IUPHAR
D(2) dopamine receptor	GPCR		DRD2_RAT	ANTAGONIST	Ki	8.77	IUPHAR

External reference:

ID	Source
D04820	KEGG_DRUG
367514-88-3	SECONDARY_CAS_RN
4030294	VANDF
4030301	VANDF
CHEBI:70735	CHEBI
CHEMBL1237021	ChEMBL_ID
CHEMBL1615372	ChEMBL_ID
7461	IUPHAR_LIGAND_ID
8247	INN_ID
DB08815	DRUGBANK_ID
22IC88528T	UNII
213046	PUBCHEM_CID
1040027	RXNORM
177747	MMSL
27589	MMSL
d07705	MMSL
013606	NDDF
013607	NDDF
703115008	SNOMEDCT_US
703116009	SNOMEDCT_US
715585000	SNOMEDCT_US
D000069056	MESH_DESCRIPTOR_UI
C2003424	UMLSCUI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Lurasidone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	13668-464	TABLET, FILM COATED	20 mg	ORAL	ANDA	24 sections
Lurasidone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	13668-465	TABLET, FILM COATED	40 mg	ORAL	ANDA	24 sections
Lurasidone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	13668-466	TABLET, FILM COATED	80 mg	ORAL	ANDA	24 sections
Lurasidone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	13668-467	TABLET, FILM COATED	120 mg	ORAL	ANDA	24 sections
Lurasidone Hydrochloride	Human Prescription Drug Label	1	46708-494	TABLET, FILM COATED	20 mg	ORAL	ANDA	31 sections
Lurasidone Hydrochloride	Human Prescription Drug Label	1	46708-495	TABLET, FILM COATED	40 mg	ORAL	ANDA	31 sections
Lurasidone Hydrochloride	Human Prescription Drug Label	1	46708-496	TABLET, FILM COATED	60 mg	ORAL	ANDA	31 sections
Lurasidone Hydrochloride	Human Prescription Drug Label	1	46708-497	TABLET, FILM COATED	80 mg	ORAL	ANDA	31 sections
Lurasidone Hydrochloride	Human Prescription Drug Label	1	46708-498	TABLET, FILM COATED	120 mg	ORAL	ANDA	31 sections
Lurasidone Hydrochloride	Human Prescription Drug Label	1	62332-494	TABLET, FILM COATED	20 mg	ORAL	ANDA	31 sections
Lurasidone Hydrochloride	Human Prescription Drug Label	1	62332-495	TABLET, FILM COATED	40 mg	ORAL	ANDA	31 sections
Lurasidone Hydrochloride	Human Prescription Drug Label	1	62332-496	TABLET, FILM COATED	60 mg	ORAL	ANDA	31 sections
Lurasidone Hydrochloride	Human Prescription Drug Label	1	62332-497	TABLET, FILM COATED	80 mg	ORAL	ANDA	31 sections
Lurasidone Hydrochloride	Human Prescription Drug Label	1	62332-498	TABLET, FILM COATED	120 mg	ORAL	ANDA	31 sections
Latuda	HUMAN PRESCRIPTION DRUG LABEL	1	63402-302	TABLET, FILM COATED	20 mg	ORAL	NDA	32 sections
Latuda	HUMAN PRESCRIPTION DRUG LABEL	1	63402-304	TABLET, FILM COATED	40 mg	ORAL	NDA	32 sections
Latuda	HUMAN PRESCRIPTION DRUG LABEL	1	63402-306	TABLET, FILM COATED	60 mg	ORAL	NDA	32 sections
Latuda	HUMAN PRESCRIPTION DRUG LABEL	1	63402-308	TABLET, FILM COATED	80 mg	ORAL	NDA	32 sections
Latuda	HUMAN PRESCRIPTION DRUG LABEL	1	63402-312	TABLET, FILM COATED	120 mg	ORAL	NDA	32 sections
Lurasidone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	65162-082	TABLET, COATED	60 mg	ORAL	ANDA	29 sections
Lurasidone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	65162-879	TABLET, COATED	20 mg	ORAL	ANDA	29 sections
Lurasidone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	65162-880	TABLET, COATED	40 mg	ORAL	ANDA	29 sections
Lurasidone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	65162-881	TABLET, COATED	80 mg	ORAL	ANDA	29 sections
Lurasidone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	65162-882	TABLET, COATED	120 mg	ORAL	ANDA	29 sections
Latuda	HUMAN PRESCRIPTION DRUG LABEL	1	70518-1812	TABLET, FILM COATED	60 mg	ORAL	NDA	31 sections
Latuda	HUMAN PRESCRIPTION DRUG LABEL	1	70518-1936	TABLET, FILM COATED	120 mg	ORAL	NDA	31 sections
Latuda	HUMAN PRESCRIPTION DRUG LABEL	1	70518-3010	TABLET, FILM COATED	80 mg	ORAL	NDA	31 sections