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

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
Completed suicide 479.21 41.16 127 817 20907 2336234
Blood prolactin abnormal 268.74 41.16 35 909 75 2357066
Sedation 265.61 41.16 56 888 3306 2353835
Anosognosia 263.18 41.16 33 911 44 2357097
Sexual dysfunction 260.69 41.16 39 905 293 2356848
Dystonia 258.71 41.16 51 893 2143 2354998
Suicide attempt 211.99 41.16 59 885 11223 2345918
Metabolic disorder 201.40 41.16 34 910 584 2356557
Disturbance in social behaviour 200.38 41.16 29 915 167 2356974
Dyskinesia 192.71 41.16 46 898 4743 2352398
Personality change 154.92 41.16 29 915 912 2356229
Psychotic disorder 127.89 41.16 33 911 4646 2352495
Weight increased 115.51 41.16 44 900 22293 2334848
Schizophrenia 109.04 41.16 23 921 1336 2355805
Mania 106.06 41.16 25 919 2415 2354726
Blood glucose increased 104.33 41.16 35 909 12255 2344886
Drug ineffective 104.30 41.16 66 878 101558 2255583
Akathisia 104.27 41.16 23 921 1651 2355490
Insurance issue 95.34 41.16 17 927 403 2356738
Off label use 93.77 41.16 55 889 73543 2283598
Toxicity to various agents 89.61 41.16 41 903 32713 2324428
Blood prolactin increased 85.23 41.16 18 926 1049 2356092
Condition aggravated 68.90 41.16 34 910 31945 2325196
Suicidal ideation 64.96 41.16 24 920 11063 2346078
Agitation 61.36 41.16 23 921 11028 2346113
Swollen tongue 56.47 41.16 18 926 5325 2351816
Adverse drug reaction 56.23 41.16 20 924 8263 2348878
Pregnancy 53.22 41.16 19 925 7930 2349211
Bipolar disorder 49.42 41.16 12 932 1306 2355835
Angioedema 48.50 41.16 18 926 8378 2348763
Parkinsonism 47.83 41.16 12 932 1493 2355648
Tardive dyskinesia 46.35 41.16 12 932 1692 2355449
Tremor 44.48 41.16 22 922 20639 2336502
Depression 43.53 41.16 24 920 28108 2329033
Anxiety 42.58 41.16 24 920 29335 2327806

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
Completed suicide 136.78 44.89 46 536 16266 1729933
Psychotic disorder 125.09 44.89 33 549 5023 1741176
Schizophrenia 94.09 44.89 22 560 2024 1744175
Anosognosia 92.85 44.89 13 569 55 1746144
Hallucination, auditory 67.70 44.89 17 565 2100 1744099
Drug ineffective 63.68 44.89 41 541 63760 1682439
Dystonia 63.53 44.89 16 566 1998 1744201
Blood prolactin abnormal 62.69 44.89 9 573 47 1746152
Off label use 62.61 44.89 34 548 38537 1707662
Aggression 60.22 44.89 21 561 8094 1738105
Dyskinesia 57.76 44.89 17 565 3802 1742397
Tremor 57.25 44.89 23 559 13108 1733091
Weight increased 53.34 44.89 21 561 11336 1734863
Mania 52.92 44.89 14 568 2119 1744080
Sedation 50.74 44.89 15 567 3402 1742797
Disturbance in social behaviour 50.38 44.89 9 573 211 1745988
Metabolic disorder 48.23 44.89 10 572 522 1745677
Suicidal ideation 48.01 44.89 18 564 8500 1737699
Paranoia 47.88 44.89 13 569 2168 1744031

Pharmacologic Action:

SourceCodeDescription
ATC N05AE05 NERVOUS SYSTEM
PSYCHOLEPTICS
ANTIPSYCHOTICS
Indole derivatives
MeSH PA D018663 Adrenergic Agents
MeSH PA D058669 Adrenergic alpha-2 Receptor Antagonists
FDA EPC N0000175430 Atypical Antipsychotic
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
CHEBI has role CHEBI:37887 adrenergic antagonist
CHEBI has role CHEBI:48561 dopaminergic antagonist
CHEBI has role CHEBI:48279 serotonergic antagonist
CHEBI has role CHEBI:65191 second generation antipsychotic
MeSH PA D014149 Tranquilizing Agents

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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
20MG LATUDA SUNOVION PHARMS INC N200603 Dec. 7, 2011 RX TABLET ORAL Jan. 27, 2020 NEW PATIENT POPULATION
20MG LATUDA SUNOVION PHARMS INC N200603 Dec. 7, 2011 RX TABLET ORAL Jan. 27, 2020 REVISIONS TO THE PEDIATRIC USE SECTION OF THE LABELING REFLECTING LACK OF EFFICACY FOR IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS AGES 6-17
40MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL Jan. 27, 2020 NEW PATIENT POPULATION
40MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL Jan. 27, 2020 REVISIONS TO THE PEDIATRIC USE SECTION OF THE LABELING REFLECTING LACK OF EFFICACY FOR IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS AGES 6-17
60MG LATUDA SUNOVION PHARMS INC N200603 July 12, 2013 RX TABLET ORAL Jan. 27, 2020 NEW PATIENT POPULATION
60MG LATUDA SUNOVION PHARMS INC N200603 July 12, 2013 RX TABLET ORAL Jan. 27, 2020 REVISIONS TO THE PEDIATRIC USE SECTION OF THE LABELING REFLECTING LACK OF EFFICACY FOR IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS AGES 6-17
80MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL Jan. 27, 2020 NEW PATIENT POPULATION
20MG LATUDA SUNOVION PHARMS INC N200603 Dec. 7, 2011 RX TABLET ORAL July 27, 2020 PEDIATRIC EXCLUSIVITY
40MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL July 27, 2020 PEDIATRIC EXCLUSIVITY
60MG LATUDA SUNOVION PHARMS INC N200603 July 12, 2013 RX TABLET ORAL July 27, 2020 PEDIATRIC EXCLUSIVITY
80MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL July 27, 2020 PEDIATRIC EXCLUSIVITY
20MG LATUDA SUNOVION PHARMS INC N200603 Dec. 7, 2011 RX TABLET ORAL March 5, 2021 NEW PATIENT POPULATION
40MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL March 5, 2021 NEW PATIENT POPULATION
60MG LATUDA SUNOVION PHARMS INC N200603 July 12, 2013 RX TABLET ORAL March 5, 2021 NEW PATIENT POPULATION
80MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL March 5, 2021 NEW PATIENT POPULATION

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
5-hydroxytryptamine receptor 1A GPCR Ki 8.20 DRUG LABEL
Alpha-2A adrenergic receptor GPCR Ki 7.39 DRUG LABEL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 8.69 IUPHAR
5-hydroxytryptamine receptor 1A GPCR AGONIST Ki 8.17 IUPHAR
D(2) dopamine receptor GPCR ANTAGONIST Ki 8.77 IUPHAR

External reference:

IDSource
D000069056 MESH_DESCRIPTOR_UI
C2954611 UMLSCUI
D04820 KEGG_DRUG
22IC88528T UNII
8247 INN_ID
715585000 SNOMEDCT_US
1040028 RXNORM
d07705 MMSL
4030301 VANDF
013606 NDDF
703115008 SNOMEDCT_US
367514-88-3 SECONDARY_CAS_RN
DB08815 DRUGBANK_ID
CHEBI:70735 CHEBI
CHEMBL1237021 ChEMBL_ID
CHEMBL1615372 ChEMBL_ID
213046 PUBCHEM_CID
7461 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Latuda HUMAN PRESCRIPTION DRUG LABEL 1 63402-302 TABLET, FILM COATED 20 mg ORAL NDA 20 sections
Latuda HUMAN PRESCRIPTION DRUG LABEL 1 63402-304 TABLET, FILM COATED 40 mg ORAL NDA 20 sections
Latuda HUMAN PRESCRIPTION DRUG LABEL 1 63402-306 TABLET, FILM COATED 60 mg ORAL NDA 20 sections
Latuda HUMAN PRESCRIPTION DRUG LABEL 1 63402-308 TABLET, FILM COATED 80 mg ORAL NDA 20 sections
Latuda HUMAN PRESCRIPTION DRUG LABEL 1 63402-312 TABLET, FILM COATED 120 mg ORAL NDA 20 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 65162-082 TABLET, COATED 60 mg ORAL ANDA 20 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 65162-879 TABLET, COATED 20 mg ORAL ANDA 20 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 65162-880 TABLET, COATED 40 mg ORAL ANDA 20 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 65162-881 TABLET, COATED 80 mg ORAL ANDA 20 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 65162-882 TABLET, COATED 120 mg ORAL ANDA 20 sections
Latuda HUMAN PRESCRIPTION DRUG LABEL 1 70518-1812 TABLET, FILM COATED 60 mg ORAL NDA 20 sections
Latuda HUMAN PRESCRIPTION DRUG LABEL 1 70518-1824 TABLET, FILM COATED 20 mg ORAL NDA 20 sections
Latuda HUMAN PRESCRIPTION DRUG LABEL 1 70518-1936 TABLET, FILM COATED 120 mg ORAL NDA 20 sections