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 1377.15 35.86 232 2857 1067 2353929
Blood prolactin increased 947.02 35.86 164 2925 903 2354093
Extrapyramidal disorder 503.85 35.86 110 2979 2237 2352759
Amenorrhoea 436.50 35.86 97 2992 2142 2352854
Psychotic disorder 433.27 35.86 111 2978 4568 2350428
Schizophrenia 401.71 35.86 83 3006 1276 2353720
Hyperprolactinaemia 370.92 35.86 70 3019 652 2354344
Dystonia 330.10 35.86 77 3012 2117 2352879
Weight increased 314.09 35.86 126 2963 22211 2332785
Suicide attempt 300.81 35.86 102 2987 11180 2343816
Neuroleptic malignant syndrome 281.41 35.86 67 3022 2013 2352983
Treatment noncompliance 272.62 35.86 80 3009 5454 2349542
Sedation 268.48 35.86 71 3018 3291 2351705
Blood prolactin abnormal 256.97 35.86 39 3050 71 2354925
Akathisia 242.46 35.86 57 3032 1617 2353379
Dyskinesia 217.30 35.86 65 3024 4724 2350272
Intentional self-injury 191.46 35.86 57 3032 4070 2350926
Intentional overdose 190.85 35.86 73 3016 11248 2343748
Tremor 166.81 35.86 79 3010 20582 2334414
Drug ineffective 161.11 35.86 138 2951 101486 2253510
Completed suicide 159.37 35.86 77 3012 20957 2334039
Breast discharge 155.77 35.86 30 3059 312 2354684
Hospitalisation 155.20 35.86 68 3021 14785 2340211
Tachycardia 145.55 35.86 67 3022 16342 2338654
Hallucination, auditory 145.27 35.86 40 3049 2152 2352844
Anosognosia 140.15 35.86 22 3067 55 2354941
Catatonia 139.19 35.86 32 3057 818 2354178
Sexual dysfunction 138.14 35.86 27 3062 305 2354691
Tardive dyskinesia 135.94 35.86 36 3053 1668 2353328
Off label use 133.01 35.86 108 2981 73490 2281506
Disturbance in social behaviour 132.59 35.86 24 3065 172 2354824
Agitation 129.84 35.86 55 3034 10996 2344000
Parkinsonism 121.02 35.86 32 3057 1473 2353523
Anxiety 116.60 35.86 70 3019 29289 2325707
Psychotic symptom 112.26 35.86 21 3068 184 2354812
Inappropriate schedule of product administration 111.80 35.86 51 3038 12153 2342843
Metabolic disorder 110.50 35.86 25 3064 593 2354403
Somnolence 103.71 35.86 60 3029 23425 2331571
Mania 101.45 35.86 31 3058 2409 2352587
Suicidal ideation 100.49 35.86 46 3043 11041 2343955
Condition aggravated 98.69 35.86 65 3024 31914 2323082
Delusion 97.76 35.86 29 3060 2036 2352960
Overdose 96.31 35.86 54 3035 19853 2335143
Aggression 95.59 35.86 35 3054 4751 2350245
Depression 93.70 35.86 60 3029 28072 2326924
Insomnia 90.86 35.86 57 3032 25730 2329266
Personality change 90.13 35.86 23 3066 918 2354078
Hallucination 87.23 35.86 38 3051 8110 2346886
Delirium 85.42 35.86 33 3056 5190 2349806
Rhabdomyolysis 84.14 35.86 35 3054 6669 2348327
Incorrect dose administered 84.01 35.86 39 3050 9656 2345340
Restlessness 78.80 35.86 30 3059 4533 2350463
Blood glucose increased 78.11 35.86 40 3049 12250 2342746
Depressive symptom 76.01 35.86 18 3071 524 2354472
Psychiatric symptom 71.98 35.86 19 3070 867 2354129
Abnormal behaviour 67.04 35.86 27 3062 4733 2350263
Electrocardiogram QT prolonged 66.33 35.86 31 3058 7783 2347213
Blood creatine phosphokinase increased 65.05 35.86 27 3062 5109 2349887
Seizure 64.12 35.86 45 3044 24421 2330575
Muscle rigidity 62.44 35.86 20 3069 1811 2353185
Adverse drug reaction 61.58 35.86 30 3059 8253 2346743
Insurance issue 59.16 35.86 14 3075 406 2354590
Product use issue 58.75 35.86 33 3056 12136 2342860
Pulmonary embolism 58.71 35.86 38 3051 18045 2336951
Musculoskeletal stiffness 58.55 35.86 33 3056 12214 2342782
Exposure during pregnancy 58.33 35.86 43 3046 25176 2329820
Sluggishness 56.12 35.86 16 3073 974 2354022
Hyponatraemia 55.96 35.86 33 3056 13292 2341704
Paranoia 55.74 35.86 19 3070 2088 2352908
Adverse event 54.72 35.86 27 3062 7632 2347364
Drug interaction 52.78 35.86 43 3046 29120 2325876
Oculogyric crisis 50.77 35.86 12 3077 346 2354650
Coma 50.44 35.86 27 3062 9029 2345967
Breast enlargement 50.28 35.86 12 3077 361 2354635
Product dose omission 50.28 35.86 47 3042 38210 2316786
Breast tenderness 49.52 35.86 13 3076 580 2354416
Oedema peripheral 49.35 35.86 38 3051 23725 2331271
Hypotension 46.80 35.86 42 3047 32394 2322602
Depressed level of consciousness 46.11 35.86 24 3065 7580 2347416
Mental impairment 45.58 35.86 17 3072 2423 2352573
Renal impairment 45.02 35.86 26 3063 10066 2344930
Schizoaffective disorder 44.18 35.86 10 3079 237 2354759
Diabetes mellitus 43.58 35.86 23 3066 7472 2347524
Product use in unapproved indication 42.51 35.86 26 3063 11174 2343822
Sudden death 42.35 35.86 15 3074 1845 2353151
Psychomotor hyperactivity 41.87 35.86 15 3074 1907 2353089
Dysphagia 41.76 35.86 27 3062 12778 2342218
Pituitary tumour benign 41.39 35.86 10 3079 317 2354679
Inappropriate antidiuretic hormone secretion 39.19 35.86 15 3074 2294 2352702
Drug abuse 38.34 35.86 25 3064 12001 2342995
Ovarian germ cell cancer stage II 38.10 35.86 5 3084 0 2354996
Toxicity to various agents 36.90 35.86 37 3052 32717 2322279
Psychotic behaviour 36.36 35.86 8 3081 166 2354830
Confusional state 36.04 35.86 32 3057 24312 2330684

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
Psychotic disorder 540.46 40.38 153 3326 4903 1738399
Extrapyramidal disorder 499.40 40.38 123 3356 2254 1741048
Schizophrenia 385.03 40.38 97 3382 1949 1741353
Akathisia 383.80 40.38 89 3390 1239 1742063
Dystonia 342.06 40.38 88 3391 1926 1741376
Treatment noncompliance 324.12 40.38 104 3375 5097 1738205
Intentional self-injury 289.93 40.38 82 3397 2591 1740711
Neuroleptic malignant syndrome 272.31 40.38 81 3398 3067 1740235
Weight increased 268.48 40.38 111 3368 11246 1732056
Inappropriate schedule of product administration 265.02 40.38 98 3381 7361 1735941
Aggression 260.59 40.38 99 3380 8016 1735286
Suicide attempt 258.64 40.38 96 3383 7285 1736017
Off label use 258.10 40.38 160 3319 38411 1704891
Drug ineffective 241.12 40.38 186 3293 63615 1679687
Hospitalisation 236.95 40.38 105 3374 12595 1730707
Sedation 203.09 40.38 66 3413 3351 1739951
Completed suicide 194.15 40.38 99 3380 16213 1727089
Intentional overdose 187.88 40.38 77 3402 7593 1735709
Hallucination, auditory 176.53 40.38 53 3426 2064 1741238
Tachycardia 162.90 40.38 81 3398 12547 1730755
Suicidal ideation 160.46 40.38 71 3408 8447 1734855
Blood prolactin increased 148.65 40.38 34 3445 440 1742862
Psychiatric symptom 145.37 40.38 37 3442 769 1742533
Delusion 144.37 40.38 46 3433 2185 1741117
Parkinsonism 139.26 40.38 40 3439 1329 1741973
Catatonia 137.11 40.38 36 3443 849 1742453
Condition aggravated 136.36 40.38 86 3393 21064 1722238
Gynaecomastia 129.91 40.38 42 3437 2090 1741212
Dyskinesia 123.78 40.38 47 3432 3772 1739530
Agitation 122.52 40.38 64 3415 10962 1732340
Tremor 120.18 40.38 67 3412 13064 1730238
Pulmonary embolism 117.79 40.38 66 3413 12993 1730309
Blood creatine phosphokinase increased 117.62 40.38 58 3421 8798 1734504
Rhabdomyolysis 116.49 40.38 62 3417 11028 1732274
Delirium 110.04 40.38 50 3429 6312 1736990
Psychotic symptom 103.13 40.38 22 3457 201 1743101
Mania 101.95 40.38 35 3444 2098 1741204
Tardive dyskinesia 100.99 40.38 30 3449 1122 1742180
Anxiety 97.09 40.38 62 3417 15465 1727837
Incorrect dose administered 96.78 40.38 48 3431 7361 1735941
Restlessness 90.95 40.38 39 3440 4282 1739020
Musculoskeletal stiffness 88.58 40.38 42 3437 5834 1737468
Muscle rigidity 83.18 40.38 29 3450 1819 1741483
Overdose 81.08 40.38 57 3422 16644 1726658
Hallucination 81.02 40.38 44 3435 8126 1735176
Hyperprolactinaemia 79.01 40.38 18 3461 228 1743074
Somnolence 78.64 40.38 56 3423 16683 1726619
Erectile dysfunction 76.63 40.38 35 3444 4462 1738840
Product dose omission 76.54 40.38 62 3417 22378 1720924
Sexual dysfunction 75.91 40.38 27 3452 1796 1741506
Insomnia 75.42 40.38 54 3425 16222 1727080
Abnormal behaviour 73.76 40.38 38 3441 6304 1736998
Depression 71.99 40.38 53 3426 16616 1726686
Salivary hypersecretion 65.96 40.38 23 3456 1442 1741860
Product use issue 63.06 40.38 38 3441 8533 1734769
Drooling 62.51 40.38 19 3460 768 1742534
Sudden death 60.08 40.38 26 3453 2914 1740388
Water intoxication 59.25 40.38 13 3466 137 1743165
Hyponatraemia 58.82 40.38 37 3442 8963 1734339
Irritability 58.19 40.38 31 3448 5501 1737801
Paranoia 57.05 40.38 23 3456 2158 1741144
Priapism 54.63 40.38 20 3459 1444 1741858
Malaise 52.79 40.38 57 3422 29508 1713794
Seizure 50.45 40.38 47 3432 20394 1722908
Therapeutic response decreased 50.03 40.38 28 3451 5472 1737830
Disturbance in social behaviour 49.16 40.38 12 3467 208 1743094
Galactorrhoea 45.78 40.38 10 3469 103 1743199
Swollen tongue 45.14 40.38 21 3458 2787 1740515
Drug interaction 43.19 40.38 50 3429 27908 1715394
Trismus 42.19 40.38 13 3466 550 1742752
Apathy 42.12 40.38 16 3463 1280 1742022
Mental impairment 42.11 40.38 18 3461 1955 1741347
Electrocardiogram QT prolonged 41.83 40.38 25 3454 5520 1737782

Pharmacologic Action:

SourceCodeDescription
ATC N05AX13 NERVOUS SYSTEM
PSYCHOLEPTICS
ANTIPSYCHOTICS
Other antipsychotics
FDA EPC N0000175430 Atypical Antipsychotic
CHEBI has role CHEBI:48561 dopaminergic antagonist
CHEBI has role CHEBI:48279 serotonergic antagonist
CHEBI has role CHEBI:37890 alpha-adrenergic antagonist
CHEBI has role CHEBI:37955 H1-receptor antagonist
CHEBI has role CHEBI:35471 psychotropic drug
CHEBI has role CHEBI:65191 second generation antipsychotic
CHEBI has role CHEBI:63726 neuroprotective agent

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
C0753678 UMLSCUI
D05339 KEGG_DRUG
117004004 SNOMEDCT_US
425483000 SNOMEDCT_US
679314 RXNORM
23004 MMSL
d06297 MMSL
4025875 VANDF
426276000 SNOMEDCT_US
011888 NDDF
838F01T721 UNII
7977 INN_ID
CHEMBL1621 ChEMBL_ID
DB01267 DRUGBANK_ID
CHEBI:82978 CHEBI
115237 PUBCHEM_CID
7258 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0378-3978 TABLET, FILM COATED, EXTENDED RELEASE 1.50 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0378-3979 TABLET, FILM COATED, EXTENDED RELEASE 3 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0378-3980 TABLET, FILM COATED, EXTENDED RELEASE 6 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0378-3981 TABLET, FILM COATED, EXTENDED RELEASE 9 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0591-3692 TABLET, FILM COATED, EXTENDED RELEASE 1.50 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0591-3693 TABLET, FILM COATED, EXTENDED RELEASE 3 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0591-3694 TABLET, FILM COATED, EXTENDED RELEASE 6 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0591-3695 TABLET, FILM COATED, EXTENDED RELEASE 9 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6935 TABLET, EXTENDED RELEASE 3 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6936 TABLET, EXTENDED RELEASE 6 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6937 TABLET, EXTENDED RELEASE 9 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 10147-0951 TABLET, EXTENDED RELEASE 1.50 mg ORAL NDA 20 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 10147-0952 TABLET, EXTENDED RELEASE 3 mg ORAL NDA 20 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 10147-0953 TABLET, EXTENDED RELEASE 6 mg ORAL NDA 20 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 10147-0954 TABLET, EXTENDED RELEASE 9 mg ORAL NDA 20 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 16714-866 TABLET, EXTENDED RELEASE 1.50 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 16714-867 TABLET, EXTENDED RELEASE 3 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 16714-868 TABLET, EXTENDED RELEASE 6 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 16714-869 TABLET, EXTENDED RELEASE 9 mg ORAL ANDA 19 sections
INVEGA HUMAN PRESCRIPTION DRUG LABEL 1 21695-455 TABLET, EXTENDED RELEASE 6 mg ORAL NDA 20 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 42292-026 TABLET, FILM COATED, EXTENDED RELEASE 3 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 42292-027 TABLET, FILM COATED, EXTENDED RELEASE 6 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 42292-055 TABLET, FILM COATED, EXTENDED RELEASE 9 mg ORAL ANDA 19 sections
PALIPERIDONE HUMAN PRESCRIPTION DRUG LABEL 1 43975-349 TABLET, EXTENDED RELEASE 1.50 mg ORAL ANDA 19 sections
PALIPERIDONE HUMAN PRESCRIPTION DRUG LABEL 1 43975-350 TABLET, EXTENDED RELEASE 3 mg ORAL ANDA 19 sections
PALIPERIDONE HUMAN PRESCRIPTION DRUG LABEL 1 43975-351 TABLET, EXTENDED RELEASE 6 mg ORAL ANDA 19 sections
PALIPERIDONE HUMAN PRESCRIPTION DRUG LABEL 1 43975-352 TABLET, EXTENDED RELEASE 9 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 47335-744 TABLET, EXTENDED RELEASE 1.50 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 47335-765 TABLET, EXTENDED RELEASE 3 mg ORAL ANDA 19 sections
Paliperidone HUMAN PRESCRIPTION DRUG LABEL 1 47335-766 TABLET, EXTENDED RELEASE 6 mg ORAL ANDA 19 sections