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

Stem definitionDrug idCAS RN
antipsychotics, risperidone derivatives 4137 144598-75-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • RO76477
  • RO 76477
  • paliperidone
  • invega
  • xeplion
  • Molecular weight: 426.49
  • Formula: C23H27FN4O3
  • CLOGP: 1.07
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 1
  • TPSA: 82.17
  • ALOGS: -3.16
  • ROTB: 4

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
6 mg O
2.50 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.01 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 59 % Benet LZ, Broccatelli F, Oprea TI
BA (Bioavailability) 28 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance) 1.18 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.24 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 24.60 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 25, 2007 EMA
Dec. 19, 2006 FDA JANSSEN PHARMS

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
Galactorrhoea 1031.06 20.52 228 11136 3569 46671129
Blood prolactin increased 773.41 20.52 173 11191 2854 46671844
Schizophrenia 490.11 20.52 149 11215 8419 46666279
Blood prolactin abnormal 425.65 20.52 91 11273 1198 46673500
Dystonia 355.94 20.52 125 11239 11132 46663566
Hyperprolactinaemia 351.26 20.52 91 11273 2841 46671857
Extrapyramidal disorder 336.77 20.52 120 11244 11148 46663550
Anosognosia 335.28 20.52 76 11288 1329 46673369
Psychotic disorder 325.82 20.52 142 11222 22479 46652219
Amenorrhoea 320.82 20.52 109 11255 8786 46665912
Disturbance in social behaviour 309.12 20.52 74 11290 1657 46673041
Sexual dysfunction 304.50 20.52 78 11286 2325 46672373
Sedation 298.33 20.52 134 11230 22776 46651922
Suicide attempt 297.05 20.52 178 11186 54858 46619840
Metabolic disorder 248.70 20.52 76 11288 4356 46670342
Dyskinesia 242.23 20.52 125 11239 28800 46645898
Personality change 223.70 20.52 73 11291 5185 46669513
Akathisia 185.37 20.52 70 11294 7644 46667054
Neuroleptic malignant syndrome 180.39 20.52 76 11288 11046 46663652
Hallucination, auditory 176.12 20.52 74 11290 10682 46664016
Treatment noncompliance 154.60 20.52 94 11270 29637 46645061
Intentional self-injury 142.84 20.52 83 11281 24083 46650615
Breast discharge 138.43 20.52 34 11330 849 46673849
Catatonia 127.38 20.52 44 11320 3718 46670980
Intentional overdose 113.79 20.52 107 11257 64837 46609861
Delusion 107.16 20.52 53 11311 11135 46663563
Blood glucose increased 99.04 20.52 104 11260 71909 46602789
Psychotic symptom 98.15 20.52 26 11338 884 46673814
Tardive dyskinesia 97.68 20.52 44 11320 7499 46667199
Weight increased 94.08 20.52 154 11210 164319 46510379
Hospitalisation 91.57 20.52 94 11270 63291 46611407
Diarrhoea 78.44 20.52 20 11344 559582 46115116
Parkinsonism 77.14 20.52 38 11326 7910 46666788
Insurance issue 68.83 20.52 23 11341 1755 46672943
Mania 68.72 20.52 39 11325 10807 46663891
Oculogyric crisis 68.53 20.52 21 11343 1212 46673486
Agitation 67.33 20.52 75 11289 55340 46619358
Aggression 65.66 20.52 50 11314 22694 46652004
Schizoaffective disorder 53.12 20.52 18 11346 1434 46673264
Nausea 52.83 20.52 54 11310 687400 45987298
Psychiatric symptom 51.22 20.52 24 11340 4473 46670225
Tremor 50.13 20.52 96 11268 115543 46559155
Inappropriate schedule of product administration 50.04 20.52 70 11294 64943 46609755
Tachycardia 48.57 20.52 87 11277 99535 46575163
Abnormal behaviour 47.36 20.52 40 11324 21018 46653680
Pain 47.21 20.52 29 11335 476919 46197779
Paranoia 46.22 20.52 30 11334 10567 46664131
Arthralgia 45.57 20.52 16 11348 364587 46310111
Suicidal ideation 43.82 20.52 61 11303 56321 46618377
Muscle rigidity 42.96 20.52 28 11336 9933 46664765
Breast enlargement 41.14 20.52 15 11349 1482 46673216
Drug hypersensitivity 39.73 20.52 6 11358 243819 46430879
Depressive symptom 38.17 20.52 17 11347 2819 46671879
Incorrect dose administered 37.98 20.52 51 11313 45499 46629199
Salivary hypersecretion 37.68 20.52 22 11342 6423 46668275
Overdose 36.25 20.52 78 11286 101901 46572797
Psychotic behaviour 36.16 20.52 11 11353 619 46674079
Mental impairment 35.10 20.52 27 11337 12429 46662269
Rhabdomyolysis 33.54 20.52 46 11318 41863 46632835
Blood creatine phosphokinase increased 32.75 20.52 37 11327 27687 46647011
Injection site nodule 32.36 20.52 16 11348 3355 46671343
Terminal dribbling 32.12 20.52 6 11358 37 46674661
Headache 31.86 20.52 42 11322 478310 46196388
Delirium 31.52 20.52 42 11322 37186 46637512
Product administered at inappropriate site 31.16 20.52 14 11350 2369 46672329
Adverse drug reaction 30.08 20.52 45 11319 44317 46630381
Sluggishness 30.06 20.52 17 11347 4674 46670024
Pituitary tumour benign 28.96 20.52 12 11352 1669 46673029
Metabolic syndrome 28.49 20.52 11 11353 1273 46673425
Pneumonia 28.28 20.52 30 11334 376290 46298408
Pain in extremity 28.02 20.52 14 11350 258666 46416032
Hallucination 27.42 20.52 46 11318 49905 46624793
Fatigue 26.71 20.52 69 11295 608628 46066070
Restlessness 26.69 20.52 32 11332 25492 46649206
Psychiatric decompensation 26.27 20.52 10 11354 1113 46673585
Eosinophilic pleural effusion 25.52 20.52 5 11359 41 46674657
Sudden death 25.47 20.52 20 11344 9484 46665214
Monocyte count decreased 25.15 20.52 11 11353 1746 46672952
Somnolence 24.73 20.52 89 11275 156432 46518266
Inappropriate antidiuretic hormone secretion 24.20 20.52 23 11341 14079 46660619
Ovarian germ cell cancer stage II 24.11 20.52 5 11359 56 46674642
Completed suicide 23.93 20.52 84 11280 145836 46528862
Peripheral swelling 23.32 20.52 5 11359 158066 46516632
Electrocardiogram QT prolonged 22.68 20.52 43 11321 51282 46623416
Breast tenderness 22.64 20.52 11 11353 2221 46672477
Bruxism 22.26 20.52 12 11352 3005 46671693
Anaemia 22.01 20.52 18 11346 255761 46418937
Paroxysmal perceptual alteration 21.96 20.52 3 11361 0 46674698
Condition aggravated 21.62 20.52 117 11247 244935 46429763
Off label use 21.53 20.52 162 11202 379679 46295019
Epileptic encephalopathy 21.45 20.52 6 11358 251 46674447
Persecutory delusion 21.23 20.52 11 11353 2544 46672154
Lactation disorder 21.22 20.52 6 11358 261 46674437
Psychomotor hyperactivity 21.08 20.52 18 11346 9595 46665103
Sopor 20.96 20.52 25 11339 19803 46654895
Nasopharyngitis 20.54 20.52 6 11358 153992 46520706

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
Schizophrenia 515.82 20.91 180 12661 8868 29930769
Psychotic disorder 441.48 20.91 205 12636 21310 29918327
Extrapyramidal disorder 392.66 20.91 154 12687 10539 29929098
Dystonia 370.97 20.91 144 12697 9583 29930054
Akathisia 307.88 20.91 110 12731 5794 29933843
Intentional self-injury 246.81 20.91 119 12722 13413 29926224
Treatment noncompliance 224.71 20.91 138 12703 25115 29914522
Neuroleptic malignant syndrome 223.03 20.91 118 12723 16177 29923460
Sedation 197.38 20.91 109 12732 16264 29923373
Suicide attempt 195.67 20.91 146 12695 36551 29903086
Hallucination, auditory 166.17 20.91 82 12759 9707 29929930
Inappropriate schedule of product administration 159.98 20.91 134 12707 39594 29900043
Anosognosia 156.40 20.91 40 12801 654 29938983
Hospitalisation 155.18 20.91 138 12703 44181 29895456
Blood prolactin increased 144.96 20.91 44 12797 1378 29938259
Dyskinesia 141.82 20.91 98 12743 21736 29917901
Blood prolactin abnormal 139.40 20.91 37 12804 704 29938933
Weight increased 137.85 20.91 165 12676 74748 29864889
Sexual dysfunction 134.83 20.91 61 12780 5940 29933697
Disturbance in social behaviour 130.85 20.91 41 12800 1430 29938207
Gynaecomastia 121.38 20.91 63 12778 8288 29931349
Catatonia 119.36 20.91 51 12790 4329 29935308
Aggression 117.52 20.91 109 12732 36798 29902839
Delusion 112.90 20.91 68 12773 11921 29927716
Parkinsonism 111.89 20.91 57 12784 7212 29932425
Psychotic symptom 105.17 20.91 33 12808 1156 29938481
Psychiatric symptom 104.31 20.91 43 12798 3336 29936301
Hyperprolactinaemia 96.61 20.91 31 12810 1169 29938468
Suicidal ideation 93.08 20.91 95 12746 36019 29903618
Intentional overdose 85.58 20.91 97 12744 41384 29898253
Mental impairment 80.63 20.91 50 12791 9227 29930410
Metabolic disorder 78.87 20.91 36 12805 3575 29936062
Tachycardia 78.80 20.91 125 12716 73614 29866023
Mania 76.19 20.91 48 12793 9106 29930531
Drug ineffective 69.80 20.91 309 12532 340078 29599559
Apathy 65.61 20.91 38 12803 6194 29933443
Tardive dyskinesia 64.56 20.91 35 12806 5022 29934615
Diarrhoea 63.76 20.91 32 12809 334071 29605566
Blood creatine phosphokinase increased 57.74 20.91 82 12759 43766 29895871
Loss of libido 56.36 20.91 24 12817 2018 29937619
Pleurothotonus 53.06 20.91 19 12822 1004 29938633
Off label use 52.98 20.91 229 12612 249061 29690576
Muscle rigidity 52.75 20.91 40 12801 10221 29929416
Drooling 50.45 20.91 25 12816 2980 29936657
Abnormal behaviour 49.58 20.91 58 12783 25565 29914072
Sopor 48.18 20.91 39 12802 10952 29928685
Agitation 46.19 20.91 83 12758 53990 29885647
Pulmonary embolism 45.26 20.91 102 12739 78033 29861604
Rhabdomyolysis 44.92 20.91 90 12751 63490 29876147
Delirium 44.89 20.91 70 12771 40561 29899076
Water intoxication 44.68 20.91 14 12827 488 29939149
Incorrect dose administered 44.29 20.91 61 12780 31625 29908012
Sedation complication 41.41 20.91 15 12826 819 29938818
Completed suicide 40.93 20.91 114 12727 99378 29840259
Galactorrhoea 40.57 20.91 12 12829 343 29939294
Salivary hypersecretion 40.01 20.91 30 12811 7536 29932101
Persecutory delusion 39.51 20.91 19 12822 2121 29937516
Anaemia 39.46 20.91 20 12821 207972 29731665
Priapism 37.29 20.91 24 12817 4719 29934918
Myocarditis 36.61 20.91 32 12809 9979 29929658
Blepharospasm 36.29 20.91 14 12827 912 29938725
Tremor 35.68 20.91 91 12750 75272 29864365
Hallucination 35.30 20.91 70 12771 48989 29890648
Erectile dysfunction 35.05 20.91 41 12800 18061 29921576
Arthralgia 34.44 20.91 8 12833 135783 29803854
Restlessness 33.85 20.91 45 12796 22554 29917083
Condition aggravated 33.37 20.91 132 12709 137734 29801903
Pneumonia 33.14 20.91 58 12783 334248 29605389
Personality change 33.05 20.91 22 12819 4578 29935059
Paranoia 32.20 20.91 30 12811 10158 29929479
Sepsis 31.01 20.91 12 12829 146383 29793254
Sluggishness 30.02 20.91 18 12823 3125 29936512
Housebound 28.34 20.91 8 12833 193 29939444
Thinking abnormal 27.95 20.91 21 12820 5290 29934347
Blood glucose increased 27.77 20.91 73 12768 61457 29878180
Dyspnoea 27.73 20.91 64 12777 333231 29606406
Acute kidney injury 26.66 20.91 48 12793 273794 29665843
Sudden death 26.57 20.91 33 12808 15459 29924178
Somnolence 26.15 20.91 96 12745 96667 29842970
Cardiac failure congestive 25.76 20.91 3 12838 84404 29855233
Pain 25.43 20.91 22 12819 172619 29767018
Gastrointestinal haemorrhage 25.38 20.91 3 12838 83443 29856194
Product dose omission issue 24.83 20.91 91 12750 91540 29848097
Schizoaffective disorder 24.51 20.91 11 12830 1049 29938588
Pruritus 22.93 20.91 11 12830 118193 29821444
Product administered at inappropriate site 22.79 20.91 12 12829 1623 29938014
Anion gap increased 22.48 20.91 12 12829 1669 29937968
Cough 22.45 20.91 13 12828 125629 29814008
Decreased appetite 22.19 20.91 19 12822 149891 29789746
Drug use disorder 22.05 20.91 15 12826 3233 29936404
Musculoskeletal stiffness 22.05 20.91 48 12793 35833 29903804
Speech disorder 21.38 20.91 38 12803 24474 29915163
Acute psychosis 21.24 20.91 12 12829 1864 29937773
Trismus 21.18 20.91 13 12828 2352 29937285

Pharmacologic Action:

SourceCodeDescription
ATC N05AX13 NERVOUS SYSTEM
PSYCHOLEPTICS
ANTIPSYCHOTICS
Other antipsychotics
FDA EPC N0000175430 Atypical Antipsychotic
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:35471 psychopharmaceuticals
CHEBI has role CHEBI:37890 alpha-adrenoceptor antagonists
CHEBI has role CHEBI:37955 h1-receptor blockers
CHEBI has role CHEBI:48279 serotonin antagonists
CHEBI has role CHEBI:48561 dopamine blocker
CHEBI has role CHEBI:49103 drug metabolites
CHEBI has role CHEBI:63726 neuroprotective agents
CHEBI has role CHEBI:65191 atypical antipsychotics

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Schizophrenia indication 58214004 DOID:5419
Schizoaffective disorder indication 68890003 DOID:5418
Psychotic disorder indication 69322001
Mixed bipolar I disorder off-label use 16506000 DOID:3312
Bipolar disorder in remission off-label use 85248005
Bipolar affective disorder, current episode manic off-label use 191618007
Bipolar affective disorder, current episode depression off-label use 191627008 DOID:3312
Infantile autism off-label use 408857007
Depression Treatment Adjunct off-label use
Priapism contraindication 6273006 DOID:9286
Suicidal thoughts contraindication 6471006
Weight gain finding contraindication 8943002
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Senile dementia contraindication 15662003
Agranulocytosis contraindication 17182001 DOID:12987
Lowered convulsive threshold contraindication 19260006
Myocardial infarction contraindication 22298006 DOID:5844
Stenosis of intestine contraindication 23065003
Short bowel syndrome contraindication 26629001 DOID:10605
Hypovolemia contraindication 28560003
Orthostatic hypotension contraindication 28651003
Torsades de pointes contraindication 31722008
Parkinsonism contraindication 32798002
Crohn's disease contraindication 34000006
Dehydration contraindication 34095006
Hypokalemia contraindication 43339004
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Hyperlipidemia contraindication 55822004 DOID:1168
Cerebrovascular disease contraindication 62914000 DOID:6713
Substance abuse contraindication 66214007
Diabetes mellitus contraindication 73211009 DOID:9351
Extrapyramidal disease contraindication 76349003
Diffuse Lewy body disease contraindication 80098002
Hyperglycemia contraindication 80394007 DOID:4195
Leukopenia contraindication 84828003 DOID:615
Tardive dyskinesia contraindication 102449007
Increased intestinal motility contraindication 102624003
Prolonged QT interval contraindication 111975006
Seizure disorder contraindication 128613002
Hypomagnesemia contraindication 190855004
Angina pectoris contraindication 194828000
Impaired renal function disorder contraindication 197663003
Metabolic syndrome X contraindication 237602007 DOID:14221
Hyperprolactinemia contraindication 237662005 DOID:12700
Esophageal dysmotility contraindication 266434009 DOID:9192
Neutropenic disorder contraindication 303011007 DOID:1227
At risk for aspiration contraindication 371736008
Impaired cognition contraindication 386806002
Breastfeeding (mother) contraindication 413712001
Obesity contraindication 414916001 DOID:9970
Gastrointestinal hypomotility contraindication 421807004
Acquired torsion dystonia contraindication 433493000
Congenital long QT syndrome contraindication 442917000
Carcinoma of female breast contraindication 447782002
Esophageal Compression contraindication
Intestinal Cystic Fibrosis contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.78 Basic
pKa2 2.73 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 8.96 PDSP DRUG LABEL
D(2) dopamine receptor GPCR ANTAGONIST Ki 8.47 PDSP DRUG LABEL
5-hydroxytryptamine receptor 5A GPCR Ki 6.56 PDSP
Prostaglandin E2 receptor EP3 subtype GPCR Ki 5 PDSP
5-hydroxytryptamine receptor 2B GPCR Ki 7.21 PDSP
D(3) dopamine receptor GPCR Ki 9.05 PDSP
Alpha-1B adrenergic receptor GPCR Ki 9.15 PDSP
Histamine H1 receptor GPCR Ki 8.25 PDSP
5-hydroxytryptamine receptor 7 GPCR Ki 8.57 PDSP
Sodium-dependent serotonin transporter Transporter Ki 5.43 PDSP
5-hydroxytryptamine receptor 1E GPCR Ki 5.99 PDSP
5-hydroxytryptamine receptor 2C GPCR Ki 7.32 PDSP
5-hydroxytryptamine receptor 1B GPCR Ki 7.64 PDSP
5-hydroxytryptamine receptor 1D GPCR Ki 7.72 PDSP
Histamine H2 receptor GPCR Ki 6.92 PDSP
D(1B) dopamine receptor GPCR Ki 7.54 PDSP
D(4) dopamine receptor GPCR Ki 7.27 PDSP
D(1A) dopamine receptor GPCR Ki 7.39 PDSP
Alpha-2C adrenergic receptor GPCR Ki 8.20 PDSP
Alpha-2B adrenergic receptor GPCR Ki 7.64 PDSP
Alpha-2A adrenergic receptor GPCR Ki 7.93 PDSP
5-hydroxytryptamine receptor 1A GPCR Ki 6.22 PDSP
Alpha-1A adrenergic receptor GPCR Ki 8.55 WOMBAT-PK
Beta-2 adrenergic receptor GPCR Ki 5.30 PDSP
Beta-1 adrenergic receptor GPCR Ki 5.30 PDSP
Histamine H4 receptor GPCR Ki 5.06 PDSP
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.89 CHEMBL
5-hydroxytryptamine receptor 6 GPCR Ki 5.62 PDSP

External reference:

IDSource
4025875 VUID
N0000176080 NUI
D05339 KEGG_DRUG
4025875 VANDF
C2719626 UMLSCUI
CHEBI:82978 CHEBI
CHEMBL1621 ChEMBL_ID
D000068882 MESH_DESCRIPTOR_UI
DB01267 DRUGBANK_ID
7258 IUPHAR_LIGAND_ID
7977 INN_ID
838F01T721 UNII
115237 PUBCHEM_CID
679314 RXNORM
23004 MMSL
92090 MMSL
d06297 MMSL
011888 NDDF
117004004 SNOMEDCT_US
425483000 SNOMEDCT_US
426276000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0378-3978 TABLET, FILM COATED, EXTENDED RELEASE 1.50 mg ORAL ANDA 33 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0378-3979 TABLET, FILM COATED, EXTENDED RELEASE 3 mg ORAL ANDA 33 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0378-3980 TABLET, FILM COATED, EXTENDED RELEASE 6 mg ORAL ANDA 33 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0378-3981 TABLET, FILM COATED, EXTENDED RELEASE 9 mg ORAL ANDA 33 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0591-3692 TABLET, FILM COATED, EXTENDED RELEASE 1.50 mg ORAL ANDA 31 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0591-3693 TABLET, FILM COATED, EXTENDED RELEASE 3 mg ORAL ANDA 31 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0591-3694 TABLET, FILM COATED, EXTENDED RELEASE 6 mg ORAL ANDA 31 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0591-3695 TABLET, FILM COATED, EXTENDED RELEASE 9 mg ORAL ANDA 31 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6935 TABLET, EXTENDED RELEASE 3 mg ORAL ANDA 31 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6936 TABLET, EXTENDED RELEASE 6 mg ORAL ANDA 31 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6937 TABLET, EXTENDED RELEASE 9 mg ORAL ANDA 31 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 10147-0951 TABLET, EXTENDED RELEASE 1.50 mg ORAL NDA 35 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 10147-0952 TABLET, EXTENDED RELEASE 3 mg ORAL NDA 35 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 10147-0953 TABLET, EXTENDED RELEASE 6 mg ORAL NDA 35 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 10147-0954 TABLET, EXTENDED RELEASE 9 mg ORAL NDA 35 sections
Paliperidone Human Prescription Drug Label 1 16714-866 TABLET, EXTENDED RELEASE 1.50 mg ORAL ANDA 31 sections
Paliperidone Human Prescription Drug Label 1 16714-867 TABLET, EXTENDED RELEASE 3 mg ORAL ANDA 31 sections
Paliperidone Human Prescription Drug Label 1 16714-868 TABLET, EXTENDED RELEASE 6 mg ORAL ANDA 31 sections
Paliperidone Human Prescription Drug Label 1 16714-869 TABLET, EXTENDED RELEASE 9 mg ORAL ANDA 31 sections
INVEGA HUMAN PRESCRIPTION DRUG LABEL 1 21695-455 TABLET, EXTENDED RELEASE 6 mg ORAL NDA 34 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 42292-026 TABLET, FILM COATED, EXTENDED RELEASE 3 mg ORAL ANDA 33 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 42292-027 TABLET, FILM COATED, EXTENDED RELEASE 6 mg ORAL ANDA 33 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 42292-055 TABLET, FILM COATED, EXTENDED RELEASE 9 mg ORAL ANDA 33 sections
PALIPERIDONE HUMAN PRESCRIPTION DRUG LABEL 1 43975-349 TABLET, EXTENDED RELEASE 1.50 mg ORAL ANDA 34 sections
PALIPERIDONE HUMAN PRESCRIPTION DRUG LABEL 1 43975-350 TABLET, EXTENDED RELEASE 3 mg ORAL ANDA 34 sections
PALIPERIDONE HUMAN PRESCRIPTION DRUG LABEL 1 43975-351 TABLET, EXTENDED RELEASE 6 mg ORAL ANDA 34 sections
PALIPERIDONE HUMAN PRESCRIPTION DRUG LABEL 1 43975-352 TABLET, EXTENDED RELEASE 9 mg ORAL ANDA 34 sections
Paliperidone Human Prescription Drug Label 1 47335-744 TABLET, EXTENDED RELEASE 1.50 mg ORAL ANDA 31 sections
Paliperidone Human Prescription Drug Label 1 47335-765 TABLET, EXTENDED RELEASE 3 mg ORAL ANDA 31 sections
Paliperidone Human Prescription Drug Label 1 47335-766 TABLET, EXTENDED RELEASE 6 mg ORAL ANDA 31 sections