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

Stem definitionDrug idCAS RN
4168 367514-87-2

Description:

MoleculeDescription

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:

DoseUnitRoute
60 mg O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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)

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (acidic/basic)
pKa1 8.38 Basic
pKa2 0.27 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
D(2) dopamine receptor GPCR ANTAGONIST Ki 9.00 DRUG LABEL DRUG LABEL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 9.33 DRUG LABEL DRUG LABEL
5-hydroxytryptamine receptor 7 GPCR ANTAGONIST Ki 9.31 DRUG LABEL
Alpha-2C adrenergic receptor GPCR Ki 7.97 DRUG LABEL
Alpha-2A adrenergic receptor GPCR Ki 7.39 DRUG LABEL
5-hydroxytryptamine receptor 1A GPCR Ki 8.20 DRUG LABEL
5-hydroxytryptamine receptor 1A GPCR AGONIST Ki 8.17 IUPHAR
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 8.69 IUPHAR
D(2) dopamine receptor GPCR ANTAGONIST Ki 8.77 IUPHAR

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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