paliperidone palmitate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4498 199739-10-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • paliperidone palmitate
  • RO92670
  • invega sustenna
A benzisoxazole derivative and active metabolite of RISPERIDONE that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST and SEROTONIN 5-HT2 RECEPTOR ANTAGONIST. It is an ANTIPSYCHOTIC AGENT used in the treatment of SCHIZOPHRENIA.
  • Molecular weight: 664.91
  • Formula: C39H57FN4O4
  • CLOGP: 9.34
  • LIPINSKI: 2
  • HAC: 8
  • HDO: 0
  • TPSA: 88.24
  • ALOGS: -4.98
  • ROTB: 20

  • Status: OFP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
July 31, 2009 FDA JANSSEN PHARMS
Sept. 20, 2013 PMDA JANSSEN PHARMACEUTICAL K.K.

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 increased 1895.99 30.45 372 14086 2937 56274672
Galactorrhoea 1770.27 30.45 361 14097 3534 56274075
Amenorrhoea 977.69 30.45 261 14197 8725 56268884
Injection site nodule 925.64 30.45 208 14250 3311 56274298
Schizophrenia 774.84 30.45 225 14233 10274 56267335
Product dose omission issue 585.06 30.45 455 14003 204298 56073311
Blood prolactin abnormal 549.59 30.45 125 14333 2100 56275509
Inappropriate schedule of product administration 521.33 30.45 302 14156 83085 56194524
Psychotic disorder 472.13 30.45 190 14268 23368 56254241
Disturbance in social behaviour 430.48 30.45 109 14349 2932 56274677
Hospitalisation 419.69 30.45 253 14205 74747 56202862
Anosognosia 383.89 30.45 94 14364 2195 56275414
Hyperprolactinaemia 367.95 30.45 100 14358 3561 56274048
Sexual dysfunction 366.15 30.45 98 14360 3290 56274319
Off label use 348.46 30.45 556 13902 555624 55721985
Hallucination, auditory 346.38 30.45 125 14333 11399 56266210
Dystonia 340.91 30.45 126 14332 12295 56265314
Metabolic disorder 311.41 30.45 96 14362 5365 56272244
Injection site mass 307.42 30.45 127 14331 16666 56260943
Extrapyramidal disorder 305.07 30.45 116 14342 12240 56265369
Personality change 297.12 30.45 94 14364 5723 56271886
Sedation 282.46 30.45 150 14308 34704 56242905
Akathisia 279.41 30.45 99 14359 8553 56269056
Incorrect dose administered 277.57 30.45 171 14287 52376 56225233
Weight increased 272.25 30.45 314 14144 229389 56048220
Breast discharge 258.49 30.45 57 14401 824 56276785
Dyskinesia 257.88 30.45 133 14325 28975 56248634
Treatment noncompliance 254.77 30.45 137 14321 32486 56245123
Syringe issue 214.06 30.45 60 14398 2396 56275213
Psychotic symptom 198.30 30.45 50 14408 1319 56276290
Suicide attempt 193.98 30.45 142 14316 57694 56219915
Tardive dyskinesia 186.02 30.45 72 14386 7959 56269650
Delusion 182.38 30.45 78 14380 11137 56266472
Paranoia 182.27 30.45 77 14381 10667 56266942
Refusal of treatment by patient 174.29 30.45 61 14397 5077 56272532
Injection site pain 172.90 30.45 180 14278 116938 56160671
Product use in unapproved indication 167.20 30.45 193 14265 140629 56136980
Device leakage 129.55 30.45 52 14406 6323 56271286
Schizoaffective disorder 127.47 30.45 42 14416 2907 56274702
Underdose 121.96 30.45 76 14382 23681 56253928
Blood glucose increased 120.77 30.45 121 14337 75030 56202579
Therapeutic response decreased 119.75 30.45 103 14355 52655 56224954
Diarrhoea 111.52 30.45 16 14442 638491 55639118
Aggression 109.44 30.45 69 14389 21937 56255672
Product administered at inappropriate site 107.32 30.45 36 14422 2634 56274975
Nausea 103.58 30.45 34 14424 764144 55513465
Pain 90.69 30.45 29 14429 663155 55614454
Arthralgia 82.04 30.45 15 14443 501654 55775955
Accidental exposure to product 81.37 30.45 60 14398 24587 56253022
Product quality issue 80.31 30.45 66 14392 31670 56245939
Drooling 79.74 30.45 31 14427 3463 56274146
Injection site abscess 78.78 30.45 23 14435 1063 56276546
Injection site reaction 75.14 30.45 80 14378 53167 56224442
Insurance issue 73.83 30.45 30 14428 3762 56273847
Injection site swelling 71.48 30.45 71 14387 43507 56234102
Abnormal behaviour 66.13 30.45 49 14409 20223 56257386
Condition aggravated 63.89 30.45 214 14244 344684 55932925
Fatigue 63.18 30.45 66 14392 788486 55489123
Hallucination 60.93 30.45 69 14389 49080 56228529
Parkinsonism 60.54 30.45 35 14423 9511 56268098
Breast enlargement 59.91 30.45 20 14438 1441 56276168
Abdominal discomfort 58.88 30.45 3 14455 277271 56000338
Injection site induration 58.42 30.45 33 14425 8582 56269027
Suicidal ideation 58.29 30.45 73 14385 57669 56219940
Neuroleptic malignant syndrome 57.07 30.45 36 14422 11442 56266167
Headache 56.81 30.45 37 14421 559007 55718602
Joint swelling 56.10 30.45 5 14453 289795 55987814
Dyspnoea 52.76 30.45 45 14413 592532 55685077
Imprisonment 51.88 30.45 12 14446 217 56277392
Cough 51.65 30.45 4 14454 259957 56017652
Product leakage 51.61 30.45 15 14443 682 56276927
Lactation disorder 51.36 30.45 13 14445 348 56277261
Drug ineffective 51.26 30.45 406 14052 918583 55359026
Drug intolerance 50.10 30.45 5 14453 264813 56012796
Needle issue 50.06 30.45 30 14428 8708 56268901
Drug hypersensitivity 50.03 30.45 6 14452 275199 56002410
Breast tenderness 48.83 30.45 19 14439 2126 56275483
Prolactin-producing pituitary tumour 48.54 30.45 10 14448 102 56277507
Tremor 48.06 30.45 100 14358 120989 56156620
Wrong technique in product usage process 45.60 30.45 65 14393 58103 56219506
Menstruation irregular 44.72 30.45 25 14433 6371 56271238
Vomiting 44.11 30.45 38 14420 498190 55779419
Abnormal weight gain 43.86 30.45 16 14442 1499 56276110
Abdominal pain 43.84 30.45 7 14451 258798 56018811
Product administration error 43.70 30.45 39 14419 20890 56256719
Anaemia 43.63 30.45 8 14450 267503 56010106
Adverse event 43.58 30.45 62 14396 55314 56222295
Product use issue 43.20 30.45 125 14333 185916 56091693
Nasopharyngitis 42.24 30.45 4 14454 220955 56056654
Psychiatric decompensation 41.99 30.45 15 14443 1323 56276286
Social avoidant behaviour 40.37 30.45 18 14440 2834 56274775
Mania 37.91 30.45 28 14430 11492 56266117
Catatonia 37.63 30.45 19 14439 3945 56273664
Pyrexia 36.96 30.45 32 14426 418741 55858868
Back pain 36.77 30.45 8 14450 237162 56040447
Pituitary tumour benign 36.67 30.45 15 14443 1913 56275696
Pruritus 36.32 30.45 18 14440 316605 55961004
Blunted affect 35.84 30.45 9 14449 233 56277376
Pneumonia 34.85 30.45 32 14426 407066 55870543
Peripheral swelling 34.26 30.45 9 14449 234717 56042892
Breast engorgement 32.28 30.45 7 14451 93 56277516
Adverse drug reaction 32.16 30.45 59 14399 65073 56212536
Acute kidney injury 31.93 30.45 11 14447 240752 56036857
Asthenia 31.74 30.45 25 14433 342948 55934661
Psychiatric symptom 31.35 30.45 18 14440 4826 56272783

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
Product dose omission issue 1366.83 28.23 830 18620 104756 31573138
Schizophrenia 1159.70 28.23 378 19072 10452 31667442
Inappropriate schedule of product administration 1049.31 28.23 544 18906 50279 31627615
Psychotic disorder 877.04 28.23 373 19077 21920 31655974
Hospitalisation 736.30 28.23 428 19022 49379 31628515
Blood prolactin increased 669.52 28.23 163 19287 1461 31676433
Treatment noncompliance 483.32 28.23 259 19191 25425 31652469
Off label use 481.80 28.23 801 18649 346473 31331421
Hallucination, auditory 469.57 28.23 192 19258 10168 31667726
Gynaecomastia 453.97 28.23 181 19269 8973 31668921
Incorrect dose administered 441.41 28.23 274 19176 35478 31642416
Injection site nodule 425.97 28.23 112 19338 1402 31676492
Akathisia 411.05 28.23 158 19292 7095 31670799
Extrapyramidal disorder 355.87 28.23 164 19286 11614 31666280
Therapeutic response decreased 324.03 28.23 202 19248 26307 31651587
Weight increased 310.04 28.23 314 19136 82633 31595261
Paranoia 306.49 28.23 143 19307 10412 31667482
Syringe issue 279.43 28.23 107 19343 4749 31673145
Psychotic symptom 279.00 28.23 81 19369 1491 31676403
Delusion 277.22 28.23 139 19311 11858 31666036
Sexual dysfunction 271.64 28.23 111 19339 5857 31672037
Refusal of treatment by patient 238.91 28.23 95 19355 4666 31673228
Dystonia 234.84 28.23 118 19332 10107 31667787
Blood prolactin abnormal 223.67 28.23 60 19390 814 31677080
Sedation 220.30 28.23 140 19310 18825 31659069
Therapeutic product effect decreased 218.95 28.23 170 19280 31452 31646442
Aggression 214.79 28.23 180 19270 37111 31640783
Drug ineffective 208.84 28.23 621 18829 394952 31282942
Underdose 206.13 28.23 116 19334 12491 31665403
Tardive dyskinesia 172.81 28.23 79 19371 5480 31672414
Anosognosia 170.60 28.23 48 19402 785 31677109
Schizoaffective disorder 162.89 28.23 51 19399 1224 31676670
Injection site pain 162.85 28.23 149 19301 34485 31643409
Disturbance in social behaviour 162.24 28.23 55 19395 1708 31676186
Dyskinesia 152.51 28.23 116 19334 20794 31657100
Galactorrhoea 151.96 28.23 38 19412 383 31677511
Suicidal ideation 145.19 28.23 143 19307 36263 31641631
Neuroleptic malignant syndrome 141.93 28.23 102 19348 16767 31661127
Erectile dysfunction 136.52 28.23 105 19345 19130 31658764
Device leakage 122.87 28.23 62 19388 5351 31672543
Abnormal behaviour 122.81 28.23 108 19342 23720 31654174
Product administered at inappropriate site 121.54 28.23 45 19405 1815 31676079
Diarrhoea 120.20 28.23 34 19416 352375 31325519
Product leakage 119.62 28.23 32 19418 429 31677465
Injection site mass 118.18 28.23 62 19388 5802 31672092
Condition aggravated 113.19 28.23 285 19165 163724 31514170
Breast enlargement 109.27 28.23 30 19420 446 31677448
Accidental exposure to product 107.11 28.23 74 19376 11421 31666473
Suicide attempt 105.44 28.23 122 19328 37126 31640768
Drooling 102.56 28.23 46 19404 3049 31674845
Product quality issue 101.50 28.23 82 19368 16029 31661865
Psychosexual disorder 101.00 28.23 21 19429 82 31677812
Product administration error 99.02 28.23 79 19371 15168 31662726
Hallucination 97.66 28.23 131 19319 46279 31631615
Adverse event 96.82 28.23 81 19369 16624 31661270
Acute kidney injury 95.24 28.23 27 19423 279687 31398207
Hyperprolactinaemia 93.50 28.23 35 19415 1456 31676438
Needle issue 92.93 28.23 51 19399 5222 31672672
Mania 90.05 28.23 61 19389 9116 31668778
Metabolic disorder 88.67 28.23 45 19405 3929 31673965
Anaemia 88.35 28.23 13 19437 213509 31464385
Parkinsonism 87.68 28.23 56 19394 7580 31670314
Product use issue 85.73 28.23 137 19313 56622 31621272
Imprisonment 85.68 28.23 25 19425 468 31677426
Pneumonia 78.78 28.23 55 19395 335257 31342637
Sepsis 76.84 28.23 4 19446 151925 31525969
Psychiatric symptom 75.36 28.23 38 19412 3273 31674621
Product use in unapproved indication 72.11 28.23 176 19274 98995 31578899
Injection site reaction 70.64 28.23 58 19392 11593 31666301
Personality change 69.99 28.23 41 19409 4754 31673140
Catatonia 67.22 28.23 40 19410 4774 31673120
Wrong technique in product usage process 66.90 28.23 92 19358 33251 31644643
Agitation 66.20 28.23 119 19331 54050 31623844
Dyspnoea 65.24 28.23 69 19381 343410 31334484
Abdominal pain 64.89 28.23 7 19443 145945 31531949
Eye movement disorder 61.65 28.23 35 19415 3826 31674068
Retrograde ejaculation 61.49 28.23 18 19432 341 31677553
Social avoidant behaviour 61.11 28.23 32 19418 2981 31674913
Nausea 60.56 28.23 60 19390 307887 31370007
Incorrect route of product administration 58.30 28.23 52 19398 11621 31666273
Toxicity to various agents 57.24 28.23 20 19430 181467 31496427
Breast tenderness 56.52 28.23 20 19430 707 31677187
Muscle rigidity 55.29 28.23 47 19403 9850 31668044
Flat affect 54.57 28.23 20 19430 783 31677111
Pyrexia 54.40 28.23 64 19386 303776 31374118
Anxiety 54.26 28.23 150 19300 90883 31587011
Priapism 53.33 28.23 34 19416 4586 31673308
Arthralgia 47.19 28.23 17 19433 151407 31526487
Wrong product administered 46.31 28.23 32 19418 4936 31672958
Haemoglobin decreased 46.21 28.23 7 19443 112668 31565226
Cough 45.79 28.23 13 19437 134801 31543093
Asthenia 43.87 28.23 44 19406 224711 31453183
Breast discharge 43.52 28.23 9 19441 34 31677860
Fatigue 42.48 28.23 89 19361 335117 31342777
Rash 42.19 28.23 37 19413 201449 31476445
Irritability 41.22 28.23 60 19390 22829 31655065
Product packaging issue 41.20 28.23 15 19435 576 31677318
Mental impairment 40.87 28.23 39 19411 9493 31668401
Thinking abnormal 40.78 28.23 31 19419 5542 31672352
Restlessness 40.29 28.23 60 19390 23301 31654593
Pruritus 39.08 28.23 14 19436 125153 31552741
Investigation 39.02 28.23 16 19434 850 31677044
Atrial fibrillation 38.58 28.23 11 19439 113772 31564122
Intentional self-injury 38.29 28.23 44 19406 13271 31664623
Renal failure 38.15 28.23 14 19436 123316 31554578
Hypotension 37.74 28.23 42 19408 204576 31473318
Cardiac failure congestive 37.41 28.23 3 19447 79384 31598510
Medication error 37.16 28.23 57 19393 22715 31655179
Decreased appetite 34.72 28.23 26 19424 153191 31524703
Device malfunction 34.32 28.23 35 19415 9231 31668663
Adverse drug reaction 34.18 28.23 58 19392 25143 31652751
Respiratory failure 34.04 28.23 10 19440 101439 31576455
Persecutory delusion 34.03 28.23 20 19430 2332 31675562
Ejaculation failure 33.90 28.23 14 19436 757 31677137
Blood creatinine increased 33.33 28.23 7 19443 89071 31588823
Infection 31.57 28.23 6 19444 81925 31595969
Pain 30.58 28.23 42 19408 186717 31491177
Vomiting 30.44 28.23 57 19393 223916 31453978
Drug interaction 30.20 28.23 51 19399 208492 31469402
Injection site rash 30.05 28.23 22 19428 3714 31674180
Extra dose administered 29.59 28.23 21 19429 3379 31674515
Psychiatric decompensation 29.11 28.23 17 19433 1959 31675935
Tremor 29.09 28.23 108 19342 76312 31601582
Libido decreased 28.82 28.23 23 19427 4413 31673481
Platelet count decreased 28.74 28.23 16 19434 110419 31567475
Depression 28.65 28.23 121 19329 90694 31587200
Back pain 28.26 28.23 16 19434 109397 31568497

FDA Adverse Event Reporting System (Geriatric)

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 1430.32 25.28 419 21518 16349 70890158
Blood prolactin increased 1079.48 25.28 247 21690 3507 70903000
Inappropriate schedule of product administration 882.42 25.28 496 21441 107059 70799448
Product dose omission issue 833.67 25.28 621 21316 216847 70689660
Galactorrhoea 769.30 25.28 184 21753 3194 70903313
Psychotic disorder 707.47 25.28 306 21631 37395 70869112
Injection site nodule 596.93 25.28 150 21787 3220 70903287
Blood prolactin abnormal 573.48 25.28 140 21797 2656 70903851
Off label use 560.52 25.28 894 21043 742166 70164341
Disturbance in social behaviour 545.09 25.28 145 21792 3922 70902585
Hospitalisation 544.70 25.28 331 21606 82237 70824270
Sexual dysfunction 529.84 25.28 158 21779 6523 70899984
Anosognosia 523.86 25.28 131 21806 2754 70903753
Dystonia 505.13 25.28 200 21737 19506 70887001
Extrapyramidal disorder 491.68 25.28 199 21738 20551 70885956
Treatment noncompliance 487.77 25.28 253 21684 46321 70860186
Hallucination, auditory 473.21 25.28 187 21750 18141 70888366
Incorrect dose administered 456.71 25.28 274 21663 66445 70840062
Akathisia 405.56 25.28 150 21787 12143 70894364
Sedation 388.96 25.28 218 21719 46513 70859994
Amenorrhoea 381.66 25.28 124 21813 6806 70899701
Metabolic disorder 379.31 25.28 128 21809 7912 70898595
Dyskinesia 375.89 25.28 204 21733 40870 70865637
Personality change 355.48 25.28 125 21812 8745 70897762
Gynaecomastia 315.45 25.28 107 21830 6716 70899791
Suicide attempt 312.01 25.28 231 21706 79279 70827228
Syringe issue 304.24 25.28 98 21839 5230 70901277
Hyperprolactinaemia 292.73 25.28 91 21846 4322 70902185
Delusion 268.47 25.28 127 21810 19038 70887469
Paranoia 265.21 25.28 122 21815 17166 70889341
Psychotic symptom 252.56 25.28 71 21866 2367 70904140
Tardive dyskinesia 248.12 25.28 99 21838 9830 70896677
Weight increased 244.62 25.28 336 21601 241995 70664512
Refusal of treatment by patient 213.54 25.28 85 21852 8385 70898122
Aggression 213.27 25.28 151 21786 48295 70858212
Schizoaffective disorder 205.40 25.28 58 21879 1965 70904542
Neuroleptic malignant syndrome 191.26 25.28 112 21825 25895 70880612
Injection site mass 181.41 25.28 96 21841 18247 70888260
Product use in unapproved indication 166.02 25.28 258 21679 207220 70699287
Underdose 158.79 25.28 104 21833 29279 70877228
Injection site pain 156.05 25.28 187 21750 117432 70789075
Product administered at inappropriate site 140.68 25.28 49 21888 3327 70903180
Suicidal ideation 140.25 25.28 138 21799 69458 70837049
Abnormal behaviour 138.58 25.28 102 21835 34607 70871900
Diarrhoea 136.71 25.28 37 21900 783304 70123203
Therapeutic response decreased 135.04 25.28 125 21812 58328 70848179
Device leakage 134.36 25.28 63 21874 9245 70897262
Parkinsonism 123.31 25.28 70 21867 15255 70891252
Blood glucose increased 119.30 25.28 153 21784 102829 70803678
Product leakage 114.92 25.28 30 21907 751 70905756
Nausea 114.22 25.28 61 21876 852027 70054480
Drooling 111.27 25.28 47 21890 5389 70901118
Product use issue 110.69 25.28 199 21738 179738 70726769
Drug ineffective 107.05 25.28 571 21366 939181 69967326
Arthralgia 103.73 25.28 16 21921 503374 70403133
Insurance issue 96.67 25.28 38 21899 3623 70902884
Hallucination 94.16 25.28 117 21820 76143 70830364
Accidental exposure to product 93.40 25.28 74 21863 27977 70878530
Breast discharge 92.50 25.28 24 21913 586 70905921
Needle issue 90.90 25.28 51 21886 10864 70895643
Erectile dysfunction 90.80 25.28 55 21882 13507 70893000
Psychiatric symptom 89.86 25.28 43 21894 6601 70899906
Catatonia 87.35 25.28 45 21892 8088 70898419
Pain 79.82 25.28 48 21889 628768 70277739
Abdominal pain 74.85 25.28 9 21928 342118 70564389
Dyspnoea 74.82 25.28 77 21860 769983 70136524
Anaemia 70.27 25.28 19 21918 403404 70503103
Injection site abscess 68.08 25.28 23 21914 1423 70905084
Injection site reaction 65.59 25.28 79 21858 49773 70856734
Sudden death 64.66 25.28 53 21884 21011 70885496
Cough 63.29 25.28 12 21925 325365 70581142
Joint swelling 62.54 25.28 4 21933 253207 70653300
Tremor 62.15 25.28 144 21793 155480 70751027
Acute kidney injury 60.48 25.28 36 21901 474588 70431919
Fatigue 60.05 25.28 102 21835 824217 70082290
Mania 58.65 25.28 46 21891 17128 70889379
Product administration error 56.57 25.28 57 21880 29466 70877041
Mental impairment 56.32 25.28 45 21892 17210 70889297
Incorrect route of product administration 54.19 25.28 53 21884 26439 70880068
Social avoidant behaviour 53.60 25.28 27 21910 4629 70901878
Breast enlargement 53.50 25.28 19 21918 1365 70905142
Imprisonment 52.34 25.28 15 21922 536 70905971
Pruritus 51.88 25.28 21 21916 345539 70560968
Vomiting 51.32 25.28 65 21872 593046 70313461
Condition aggravated 51.13 25.28 264 21673 427371 70479136
Drug hypersensitivity 50.35 25.28 10 21927 262449 70644058
Eye movement disorder 49.35 25.28 30 21907 7410 70899097
Muscle rigidity 49.18 25.28 43 21894 18607 70887900
Psychiatric decompensation 48.68 25.28 22 21915 2965 70903542
Adverse drug reaction 47.73 25.28 70 21867 53274 70853233
Pulmonary embolism 47.32 25.28 130 21807 155737 70750770
Pyrexia 47.03 25.28 72 21865 606880 70299627
Abdominal discomfort 46.05 25.28 6 21931 214652 70691855
Rash 45.14 25.28 55 21882 510507 70396000
Injection site swelling 45.09 25.28 61 21876 43096 70863411
Pneumonia 44.98 25.28 72 21865 596160 70310347
Restlessness 44.71 25.28 60 21877 42068 70864439
Product quality issue 44.46 25.28 51 21886 30510 70875997
Mental disorder 44.28 25.28 49 21888 28191 70878316
Headache 43.86 25.28 70 21867 580335 70326172
Retrograde ejaculation 43.84 25.28 11 21926 234 70906273
Blood creatine phosphokinase increased 43.13 25.28 72 21865 61191 70845316
Abdominal pain upper 42.53 25.28 5 21932 193597 70712910
Breast tenderness 42.47 25.28 18 21919 2080 70904427
Agitation 42.41 25.28 91 21846 93284 70813223
Anxiety 42.36 25.28 157 21780 220173 70686334
Drug intolerance 40.45 25.28 10 21927 225677 70680830
Psychosexual disorder 40.24 25.28 9 21928 114 70906393
Sepsis 39.83 25.28 13 21924 244532 70661975
Rhabdomyolysis 39.73 25.28 90 21847 95670 70810837
Nasopharyngitis 39.53 25.28 10 21927 222196 70684311
Injection site induration 38.97 25.28 28 21909 9140 70897367
Asthenia 38.68 25.28 51 21886 457615 70448892
Toxicity to various agents 38.38 25.28 37 21900 382135 70524372
Back pain 38.26 25.28 18 21919 271134 70635373
Intentional self-injury 36.56 25.28 47 21890 31603 70874904
Infection 36.51 25.28 10 21927 210775 70695732
Wrong technique in product usage process 35.96 25.28 71 21866 68627 70837880
Depression 35.93 25.28 139 21798 198835 70707672
Irritability 35.41 25.28 51 21886 38174 70868333
Haemoglobin decreased 35.04 25.28 10 21927 205149 70701358
Device malfunction 35.02 25.28 36 21901 19048 70887459
Disease progression 34.52 25.28 4 21933 156668 70749839
Blunted affect 32.76 25.28 10 21927 446 70906061
Oculogyric crisis 32.10 25.28 16 21921 2682 70903825
Alopecia 31.54 25.28 11 21926 198479 70708028
Peripheral swelling 31.43 25.28 17 21920 236546 70669961
Adverse event 30.71 25.28 55 21882 49406 70857101
Injection site infection 30.54 25.28 14 21923 1950 70904557
Extra dose administered 30.42 25.28 22 21915 7255 70899252
Urinary tract infection 30.07 25.28 20 21917 248749 70657758
Bipolar disorder 29.54 25.28 22 21915 7586 70898921
Pain in extremity 29.32 25.28 35 21902 328047 70578460
Hypertension 29.31 25.28 29 21908 296004 70610503
Terminal dribbling 29.29 25.28 5 21932 12 70906495
Prolactin-producing pituitary tumour 29.16 25.28 7 21930 123 70906384
Investigation 28.60 25.28 14 21923 2257 70904250
Decreased appetite 27.78 25.28 32 21905 304748 70601759
Flat affect 27.70 25.28 13 21924 1910 70904597
Delirium 27.53 25.28 67 21870 74547 70831960
Swelling 27.39 25.28 12 21925 188527 70717980
Poor personal hygiene 27.25 25.28 9 21928 519 70905988
Saccadic eye movement 27.17 25.28 7 21930 166 70906341
Salivary hypersecretion 26.69 25.28 26 21911 12899 70893608
Menstruation irregular 26.64 25.28 17 21920 4571 70901936
Thinking abnormal 26.32 25.28 25 21912 12026 70894481
Cardiac failure congestive 26.30 25.28 5 21932 135452 70771055
Ejaculation failure 26.27 25.28 8 21929 354 70906153
Neuropathy peripheral 26.14 25.28 4 21933 126892 70779615
Soliloquy 26.14 25.28 9 21928 590 70905917
Tension 26.11 25.28 16 21921 4008 70902499
Contraindicated product administered 26.07 25.28 5 21932 134607 70771900
Renal failure 25.98 25.28 13 21924 189057 70717450
Pleural effusion 25.59 25.28 5 21932 132859 70773648

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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 psychotropic drugs
CHEBI has role CHEBI:37890 alpha-adrenergic receptor blockaders
CHEBI has role CHEBI:37955 H1 receptor antagonists
CHEBI has role CHEBI:48279 serotonin antagonists
CHEBI has role CHEBI:48561 dopaminergic antagonists
CHEBI has role CHEBI:49103 drug metabolites
CHEBI has role CHEBI:63726 neuroprotective agents
CHEBI has role CHEBI:65191 atypical antipsychotic agent

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Schizophrenia indication 58214004 DOID:5419
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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.78 Basic
pKa2 1.52 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
117MG/0.75ML (117MG/0.75ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
117MG/0.75ML (117MG/0.75ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
117MG/0.75ML (117MG/0.75ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS
117MG/0.75ML (117MG/0.75ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOPHRENIA
156MG/ML (156MG/ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
156MG/ML (156MG/ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
156MG/ML (156MG/ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS
156MG/ML (156MG/ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOPHRENIA
234MG/1.5ML (156MG/ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
234MG/1.5ML (156MG/ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
234MG/1.5ML (156MG/ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS
234MG/1.5ML (156MG/ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOPHRENIA
39MG/0.25ML (39MG/0.25ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
39MG/0.25ML (39MG/0.25ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
39MG/0.25ML (39MG/0.25ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS
39MG/0.25ML (39MG/0.25ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOPHRENIA
78MG/0.5ML (78MG/0.5ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
78MG/0.5ML (78MG/0.5ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
78MG/0.5ML (78MG/0.5ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS
78MG/0.5ML (78MG/0.5ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOPHRENIA
273MG/0.875ML (273MG/0.875ML) INVEGA TRINZA JANSSEN PHARMS N207946 May 18, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10143693 April 5, 2036 REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO
273MG/0.875ML (273MG/0.875ML) INVEGA TRINZA JANSSEN PHARMS N207946 May 18, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10143693 April 5, 2036 REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO
410MG/1.315ML (311.79MG/ML) INVEGA TRINZA JANSSEN PHARMS N207946 May 18, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10143693 April 5, 2036 REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO
410MG/1.315ML (311.79MG/ML) INVEGA TRINZA JANSSEN PHARMS N207946 May 18, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10143693 April 5, 2036 REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO
546MG/1.75ML (312MG/ML) INVEGA TRINZA JANSSEN PHARMS N207946 May 18, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10143693 April 5, 2036 REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO
546MG/1.75ML (312MG/ML) INVEGA TRINZA JANSSEN PHARMS N207946 May 18, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10143693 April 5, 2036 REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO
819MG/2.625ML (312MG/ML) INVEGA TRINZA JANSSEN PHARMS N207946 May 18, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10143693 April 5, 2036 REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO
819MG/2.625ML (312MG/ML) INVEGA TRINZA JANSSEN PHARMS N207946 May 18, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10143693 April 5, 2036 REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO
1.092GM/3.5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11304951 May 7, 2041 REINITIATION OF SCHIZOPHRENIA TREATMENT WHEREIN MORE THAN 6 MONTHS 3 WEEKS BUT LESS THAN 8 MONTHS HAVE ELAPSED SINCE THE LAST DOSE
1.092GM/3.5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11324751 May 7, 2041 TREATMENT OF SCHIZOPHRENIA BY ADMINISTERING A DOSE UP TO TWO WEEKS BEFORE OR THREE WEEKS AFTER THE SCHEDULED SIX-MONTH DOSE
1.560GM/5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11304951 May 7, 2041 REINITIATION OF SCHIZOPHRENIA TREATMENT WHEREIN MORE THAN 6 MONTHS 3 WEEKS BUT LESS THAN 8 MONTHS HAVE ELAPSED SINCE THE LAST DOSE
1.560GM/5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11324751 May 7, 2041 TREATMENT OF SCHIZOPHRENIA BY ADMINISTERING A DOSE UP TO TWO WEEKS BEFORE OR THREE WEEKS AFTER THE SCHEDULED SIX-MONTH DOSE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1.092GM/3.5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR Aug. 30, 2024 NEW STRENGTH
1.560GM/5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR Aug. 30, 2024 NEW STRENGTH

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
D(2) dopamine receptor GPCR ANTAGONIST DRUG LABEL DRUG LABEL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST DRUG LABEL DRUG LABEL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.89 CHEMBL

External reference:

IDSource
D05340 KEGG_DRUG
4029217 VUID
N0000181687 NUI
4025875 VANDF
4029217 VANDF
CHEBI:83807 CHEBI
CHEBI:82978 CHEBI
CHEMBL2107360 ChEMBL_ID
R8P8USM8FR UNII
DB01267 DRUGBANK_ID
679314 RXNORM
166838 MMSL
23004 MMSL
26654 MMSL
d06297 MMSL
011888 NDDF
013207 NDDF
117004004 SNOMEDCT_US
425483000 SNOMEDCT_US
426276000 SNOMEDCT_US
706896003 SNOMEDCT_US
C2719626 UMLSCUI
D000068882 MESH_DESCRIPTOR_UI
C0753678 UMLSCUI
9852746 PUBCHEM_CID
7977 INN_ID
115237 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
INVEGA SUSTENNA HUMAN PRESCRIPTION DRUG LABEL 1 50458-560 INJECTION 39 mg INTRAMUSCULAR NDA 35 sections
INVEGA SUSTENNA HUMAN PRESCRIPTION DRUG LABEL 1 50458-560 INJECTION 39 mg INTRAMUSCULAR NDA 35 sections
INVEGA SUSTENNA HUMAN PRESCRIPTION DRUG LABEL 1 50458-561 INJECTION 78 mg INTRAMUSCULAR NDA 35 sections
INVEGA SUSTENNA HUMAN PRESCRIPTION DRUG LABEL 1 50458-561 INJECTION 78 mg INTRAMUSCULAR NDA 35 sections
INVEGA SUSTENNA HUMAN PRESCRIPTION DRUG LABEL 1 50458-562 INJECTION 117 mg INTRAMUSCULAR NDA 35 sections
INVEGA SUSTENNA HUMAN PRESCRIPTION DRUG LABEL 1 50458-562 INJECTION 117 mg INTRAMUSCULAR NDA 35 sections
INVEGA SUSTENNA HUMAN PRESCRIPTION DRUG LABEL 1 50458-563 INJECTION 156 mg INTRAMUSCULAR NDA 35 sections
INVEGA SUSTENNA HUMAN PRESCRIPTION DRUG LABEL 1 50458-563 INJECTION 156 mg INTRAMUSCULAR NDA 35 sections
INVEGA SUSTENNA HUMAN PRESCRIPTION DRUG LABEL 1 50458-564 INJECTION 234 mg INTRAMUSCULAR NDA 35 sections
INVEGA SUSTENNA HUMAN PRESCRIPTION DRUG LABEL 1 50458-564 INJECTION 234 mg INTRAMUSCULAR NDA 35 sections
INVEGA TRINZA HUMAN PRESCRIPTION DRUG LABEL 1 50458-606 INJECTION, SUSPENSION, EXTENDED RELEASE 273 mg INTRAMUSCULAR NDA 40 sections
INVEGA TRINZA HUMAN PRESCRIPTION DRUG LABEL 1 50458-606 INJECTION, SUSPENSION, EXTENDED RELEASE 273 mg INTRAMUSCULAR NDA 40 sections
INVEGA TRINZA HUMAN PRESCRIPTION DRUG LABEL 1 50458-607 INJECTION, SUSPENSION, EXTENDED RELEASE 410 mg INTRAMUSCULAR NDA 40 sections
INVEGA TRINZA HUMAN PRESCRIPTION DRUG LABEL 1 50458-607 INJECTION, SUSPENSION, EXTENDED RELEASE 410 mg INTRAMUSCULAR NDA 40 sections
INVEGA TRINZA HUMAN PRESCRIPTION DRUG LABEL 1 50458-608 INJECTION, SUSPENSION, EXTENDED RELEASE 546 mg INTRAMUSCULAR NDA 40 sections
INVEGA TRINZA HUMAN PRESCRIPTION DRUG LABEL 1 50458-608 INJECTION, SUSPENSION, EXTENDED RELEASE 546 mg INTRAMUSCULAR NDA 40 sections
INVEGA TRINZA HUMAN PRESCRIPTION DRUG LABEL 1 50458-609 INJECTION, SUSPENSION, EXTENDED RELEASE 819 mg INTRAMUSCULAR NDA 40 sections
INVEGA TRINZA HUMAN PRESCRIPTION DRUG LABEL 1 50458-609 INJECTION, SUSPENSION, EXTENDED RELEASE 819 mg INTRAMUSCULAR NDA 40 sections
INVEGA HAFYERA HUMAN PRESCRIPTION DRUG LABEL 1 50458-611 INJECTION, SUSPENSION, EXTENDED RELEASE 1092 mg INTRAMUSCULAR NDA 38 sections
INVEGA HAFYERA HUMAN PRESCRIPTION DRUG LABEL 1 50458-612 INJECTION, SUSPENSION, EXTENDED RELEASE 1560 mg INTRAMUSCULAR NDA 38 sections