tolvaptan ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
vasopressin receptor antagonists 4110 150683-30-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • OPC 41061
  • jinarc
  • tolvaptan
  • samsca
  • OPC-41061
A benzazepine derivative and selective VASOPRESSIN V2 RECEPTOR antagonist that is used to treat euvolemic and hypervolemic HYPONATREMIA. It is also used in the treatment of rapidly progressing AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE to slow the rate of cyst development and renal insufficiency.
  • Molecular weight: 448.95
  • Formula: C26H25ClN2O3
  • CLOGP: 3.91
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 69.64
  • ALOGS: -5.56
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
30 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.91 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.90 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Oct. 27, 2010 PMDA Otsuka Pharmaceutical Co., Ltd
Feb. 26, 2015 EMA
May 19, 2009 FDA OTSUKA AMERICA PHARM

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
Rapid correction of hyponatraemia 391.16 22.04 57 8450 74 50596543
Incorrect product administration duration 343.45 22.04 106 8401 9169 50587448
Hypernatraemia 328.94 22.04 94 8413 6227 50590390
Hepatic function abnormal 287.72 22.04 130 8377 32551 50564066
Thirst 233.76 22.04 82 8425 10568 50586049
Inappropriate schedule of product administration 223.54 22.04 143 8364 71688 50524929
Cardiac failure 223.42 22.04 146 8361 75894 50520723
Renal impairment 216.75 22.04 143 8364 75518 50521099
Blood sodium decreased 145.42 22.04 71 8436 21076 50575541
Blood urea increased 143.90 22.04 73 8434 23512 50573105
Polyuria 112.30 22.04 43 8464 7078 50589539
Wrong technique in product usage process 103.68 22.04 81 8426 55429 50541188
Liver disorder 100.71 22.04 68 8439 37154 50559463
Blood sodium increased 99.70 22.04 30 8477 2372 50594245
Off label use 99.05 22.04 234 8273 474192 50122425
Polydipsia 87.90 22.04 29 8478 3095 50593522
Underdose 87.82 22.04 50 8457 20228 50576389
Alanine aminotransferase increased 87.33 22.04 90 8417 88269 50508348
Glomerular filtration rate decreased 85.74 22.04 41 8466 11611 50585006
Aspartate aminotransferase increased 85.42 22.04 84 8423 77914 50518703
Nocturia 82.90 22.04 34 8473 6696 50589921
Death 77.12 22.04 169 8338 325210 50271407
Platelet count decreased 74.26 22.04 88 8419 100638 50495979
Blood pressure decreased 60.78 22.04 60 8447 55849 50540768
Brain natriuretic peptide increased 59.62 22.04 24 8483 4503 50592114
Dehydration 58.04 22.04 97 8410 152352 50444265
Hepatic encephalopathy 56.33 22.04 29 8478 9607 50587010
Product use in unapproved indication 54.17 22.04 81 8426 115738 50480879
Gallbladder polyp 52.62 22.04 14 8493 707 50595910
Renal cyst haemorrhage 52.01 22.04 9 8498 52 50596565
Blood creatinine increased 51.95 22.04 64 8443 76096 50520521
Hospitalisation 51.10 22.04 60 8447 67877 50528740
Drug titration error 50.06 22.04 13 8494 597 50596020
Blood uric acid increased 49.37 22.04 20 8487 3814 50592803
Drug ineffective 46.40 22.04 42 8465 819291 49777326
Concomitant disease aggravated 46.28 22.04 24 8483 8067 50588550
Inability to afford medication 46.26 22.04 15 8492 1515 50595102
Incorrect drug administration rate 45.65 22.04 17 8490 2589 50594028
Hyperuricaemia 45.52 22.04 20 8487 4660 50591957
Pulmonary arterial hypertension 45.32 22.04 33 8474 20286 50576331
Nephrogenic anaemia 44.66 22.04 15 8492 1690 50594927
Cardiac failure chronic 43.87 22.04 18 8489 3545 50593072
Incorrect dose administered 41.90 22.04 46 8461 48368 50548249
Pulmonary congestion 41.55 22.04 28 8479 15219 50581398
Fatigue 40.33 22.04 36 8471 707565 49889052
Therapy cessation 38.12 22.04 33 8474 25978 50570639
Hyponatraemia 34.98 22.04 60 8447 96079 50500538
Ascites 34.41 22.04 36 8471 35825 50560792
Pain 33.48 22.04 29 8478 578874 50017743
Cerebral infarction 32.86 22.04 28 8479 21576 50575041
Renal cyst ruptured 31.53 22.04 5 8502 15 50596602
Osmotic demyelination syndrome 31.53 22.04 9 8498 591 50596026
Hepatotoxicity 31.02 22.04 30 8477 27196 50569421
Joint swelling 30.46 22.04 3 8504 245283 50351334
Pleural effusion 29.84 22.04 51 8456 81403 50515214
Urine output increased 29.54 22.04 10 8497 1154 50595463
Hepatic cirrhosis 29.25 22.04 24 8483 17553 50579064
No adverse event 29.21 22.04 32 8475 33546 50563071
Drug hypersensitivity 28.86 22.04 4 8503 251006 50345611
Pollakiuria 28.53 22.04 27 8480 23824 50572793
Renal cyst infection 28.24 22.04 6 8501 113 50596504
Concomitant disease progression 27.47 22.04 11 8496 2034 50594583
Right ventricular failure 27.08 22.04 22 8485 15871 50580746
Transfusion 26.61 22.04 20 8487 12885 50583732
Drug-induced liver injury 26.59 22.04 28 8479 28067 50568550
Pulmonary hypertension 25.91 22.04 30 8477 33387 50563230
Upper respiratory tract inflammation 25.82 22.04 11 8496 2378 50594239
Blood alkaline phosphatase increased 24.70 22.04 31 8476 37495 50559122
Abdominal discomfort 23.75 22.04 5 8502 231636 50364981
Blood bilirubin increased 23.57 22.04 28 8479 32010 50564607
Swelling 23.56 22.04 3 8504 200869 50395748
Altered state of consciousness 22.84 22.04 23 8484 21887 50574730
Rash 22.81 22.04 24 8483 437447 50159170

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
Hypernatraemia 504.73 23.12 152 8123 7234 29559018
Rapid correction of hyponatraemia 363.42 23.12 55 8220 43 29566209
Thirst 335.72 23.12 108 8167 6383 29559869
Incorrect product administration duration 296.79 23.12 88 8187 3953 29562299
Hepatic function abnormal 205.57 23.12 131 8144 39128 29527124
Renal impairment 204.10 23.12 174 8101 81159 29485093
Cardiac failure 175.49 23.12 158 8117 79129 29487123
Blood urea increased 157.56 23.12 98 8177 28014 29538238
Inappropriate schedule of product administration 144.94 23.12 111 8164 44361 29521891
Blood sodium increased 128.95 23.12 42 8233 2572 29563680
Blood creatinine increased 93.60 23.12 117 8158 84985 29481267
Hepatic encephalopathy 92.64 23.12 53 8222 12982 29553270
Polyuria 86.79 23.12 42 8233 7320 29558932
Wrong technique in product usage process 84.23 23.12 70 8205 31358 29534894
Osmotic demyelination syndrome 82.86 23.12 22 8253 654 29565598
Glomerular filtration rate decreased 80.57 23.12 46 8229 11220 29555032
Hyperuricaemia 77.30 23.12 38 8237 6851 29559401
Dehydration 70.79 23.12 120 8155 114628 29451624
Altered state of consciousness 69.90 23.12 52 8223 19837 29546415
Cardiac failure chronic 67.61 23.12 34 8241 6433 29559819
Low cardiac output syndrome 64.72 23.12 17 8258 484 29565768
Off label use 62.56 23.12 205 8070 300595 29265657
Blood sodium decreased 61.95 23.12 43 8232 14724 29551528
Underdose 60.47 23.12 39 8236 11830 29554422
Alanine aminotransferase increased 54.40 23.12 82 8193 70862 29495390
Liver disorder 52.88 23.12 51 8224 27698 29538554
Aspartate aminotransferase increased 51.53 23.12 73 8202 59652 29506600
Death 50.72 23.12 209 8066 341875 29224377
Hyperkalaemia 44.29 23.12 69 8206 61323 29504929
Nocturia 43.88 23.12 28 8247 8334 29557918
Incorrect drug administration rate 38.85 23.12 14 8261 1162 29565090
Drug titration error 38.62 23.12 11 8264 426 29565826
Product use in unapproved indication 38.60 23.12 79 8196 86796 29479456
Right ventricular failure 35.50 23.12 24 8251 7866 29558386
Blood pressure decreased 35.44 23.12 53 8222 45424 29520828
Renal cyst haemorrhage 34.92 23.12 10 8265 395 29565857
Blood potassium increased 33.85 23.12 30 8245 14621 29551631
Cerebral infarction 33.77 23.12 38 8237 24637 29541615
Polydipsia 32.68 23.12 17 8258 3448 29562804
Toxicity to various agents 32.34 23.12 5 8270 173656 29392596
Fatigue 32.25 23.12 25 8250 316796 29249456
Urine output decreased 32.09 23.12 24 8251 9214 29557038
Product use issue 30.57 23.12 53 8222 51391 29514861
Urine osmolarity decreased 30.38 23.12 6 8269 44 29566208
Inability to afford medication 29.76 23.12 11 8264 981 29565271
Renal cyst infection 29.71 23.12 6 8269 50 29566202
Concomitant disease aggravated 29.47 23.12 18 8257 4960 29561292
Hospitalisation 29.47 23.12 49 8226 45939 29520313
Procedural failure 28.12 23.12 6 8269 67 29566185
Pulmonary arterial hypertension 27.33 23.12 20 8255 7429 29558823
Prescribed underdose 26.54 23.12 20 8255 7766 29558486
Disseminated intravascular coagulation 26.03 23.12 30 8245 19950 29546302
Pain 25.74 23.12 8 8267 171424 29394828
Renal cyst ruptured 24.68 23.12 4 8271 7 29566245
Congestive hepatopathy 23.95 23.12 11 8264 1703 29564549
Oedema 23.12 23.12 41 8234 40442 29525810

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
Hypernatraemia 801.42 19.72 234 14891 11955 64471652
Thirst 511.49 19.72 172 14953 13965 64469642
Rapid correction of hyponatraemia 481.09 19.72 72 15053 70 64483537
Hepatic function abnormal 474.57 19.72 252 14873 64061 64419546
Renal impairment 395.13 19.72 294 14831 134723 64348884
Cardiac failure 375.62 19.72 283 14842 132090 64351517
Incorrect product administration duration 349.99 19.72 118 15007 9640 64473967
Blood urea increased 294.66 19.72 162 14963 43991 64439616
Inappropriate schedule of product administration 232.34 19.72 184 14941 92102 64391505
Blood sodium increased 194.13 19.72 62 15063 4264 64479343
Polyuria 173.68 19.72 76 15049 12567 64471040
Liver disorder 152.97 19.72 115 15010 53236 64430371
Hepatic encephalopathy 147.90 19.72 80 15045 20986 64462621
Off label use 143.14 19.72 396 14729 632410 63851197
Blood creatinine increased 138.89 19.72 165 14960 135617 64347990
Glomerular filtration rate decreased 136.49 19.72 74 15051 19498 64464109
Hyperuricaemia 129.47 19.72 58 15067 10133 64473474
Alanine aminotransferase increased 127.67 19.72 160 14965 138871 64344736
Aspartate aminotransferase increased 124.85 19.72 147 14978 119641 64363966
Death 115.79 19.72 309 14816 482396 64001211
Dehydration 113.32 19.72 191 14934 216572 64267035
Nocturia 106.11 19.72 52 15073 11113 64472494
Polydipsia 103.33 19.72 42 15083 5779 64477828
Cardiac failure chronic 100.82 19.72 47 15078 8994 64474613
Blood sodium decreased 94.49 19.72 68 15057 29414 64454193
Underdose 93.06 19.72 64 15061 25765 64457842
Osmotic demyelination syndrome 86.84 19.72 25 15100 1206 64482401
Altered state of consciousness 85.55 19.72 71 15054 37831 64445776
Blood pressure decreased 85.16 19.72 103 15022 86096 64397511
Drug titration error 84.13 19.72 23 15102 917 64482690
Renal cyst haemorrhage 79.29 19.72 19 15106 443 64483164
Cerebral infarction 74.69 19.72 68 15057 40976 64442631
Low cardiac output syndrome 73.71 19.72 20 15105 775 64482832
Concomitant disease aggravated 70.48 19.72 40 15085 11502 64472105
Pulmonary arterial hypertension 66.76 19.72 52 15073 25315 64458292
Toxicity to various agents 66.28 19.72 5 15120 363508 64120099
Product use in unapproved indication 63.86 19.72 133 14992 176485 64307122
Nephrogenic anaemia 62.49 19.72 25 15100 3300 64480307
Brain natriuretic peptide increased 62.09 19.72 32 15093 7601 64476006
Platelet count decreased 59.12 19.72 125 15000 167586 64316021
Wrong technique in product usage process 58.30 19.72 74 15051 64900 64418707
Hyperkalaemia 56.59 19.72 92 15033 101037 64382570
Right ventricular failure 56.47 19.72 44 15081 21427 64462180
Fatigue 56.06 19.72 56 15069 748674 63734933
Pain 53.31 19.72 32 15093 553479 63930128
Urine output decreased 52.74 19.72 38 15087 16454 64467153
Blood uric acid increased 51.76 19.72 29 15096 8134 64475473
Renal cyst infection 49.31 19.72 11 15114 185 64483422
Blood potassium increased 47.17 19.72 43 15082 25937 64457670
Ascites 46.96 19.72 65 15060 61936 64421671
Urine output increased 45.71 19.72 17 15108 1844 64481763
Therapy cessation 44.38 19.72 46 15079 32443 64451164
Transfusion 43.30 19.72 35 15090 17959 64465648
Blood bilirubin increased 43.08 19.72 60 15065 57493 64426114
Pulmonary congestion 42.33 19.72 39 15086 23841 64459766
Drug ineffective 41.85 19.72 84 15041 840163 63643444
Renal cyst ruptured 41.81 19.72 7 15118 21 64483586
Completed suicide 41.11 19.72 3 15122 224411 64259196
Gallbladder polyp 40.62 19.72 13 15112 899 64482708
Pollakiuria 40.14 19.72 43 15082 31487 64452120
Gamma-glutamyltransferase increased 39.99 19.72 53 15072 48457 64435150
Arthralgia 39.24 19.72 28 15097 442232 64041375
Hepatic failure 38.88 19.72 56 15069 55338 64428269
Hepatotoxicity 36.60 19.72 46 15079 39916 64443691
Incorrect dose administered 36.33 19.72 57 15068 60708 64422899
Joint swelling 34.01 19.72 5 15120 215377 64268230
Urine osmolarity decreased 33.65 19.72 7 15118 83 64483524
Concomitant disease progression 33.39 19.72 16 15109 3253 64480354
Pleural effusion 33.17 19.72 84 15041 126475 64357132
Product use issue 33.02 19.72 94 15031 151621 64331986
Disseminated intravascular coagulation 32.47 19.72 39 15086 32309 64451298
Rash 31.22 19.72 37 15088 458512 64025095
Prescribed underdose 31.11 19.72 29 15096 17986 64465621
Hyponatraemia 30.44 19.72 90 15035 148249 64335358
Blood alkaline phosphatase increased 29.84 19.72 50 15075 56229 64427378
Cardiac failure acute 29.56 19.72 27 15098 16317 64467290
Pulmonary hypertension 29.38 19.72 43 15082 43096 64440511
Atrial tachycardia 29.17 19.72 15 15110 3544 64480063
Drug hypersensitivity 28.65 19.72 10 15115 237805 64245802
Oedema 28.36 19.72 65 15060 91870 64391737
Procedural failure 28.19 19.72 6 15119 80 64483527
Pain in extremity 27.10 19.72 19 15106 303066 64180541
Swelling 27.03 19.72 3 15122 160215 64323392
Hepatic cirrhosis 26.88 19.72 32 15093 26266 64457341
Oesophageal varices haemorrhage 26.06 19.72 14 15111 3615 64479992
Ventricular tachycardia 26.05 19.72 36 15089 34229 64449378
Congestive hepatopathy 24.88 19.72 14 15111 3959 64479648
Drug-induced liver injury 24.82 19.72 42 15083 47601 64436006
Inability to afford medication 24.80 19.72 11 15114 1875 64481732
Drug intolerance 24.25 19.72 7 15118 187985 64295622
Neutropenia 24.22 19.72 13 15112 239611 64243996
Infected cyst 24.09 19.72 9 15116 988 64482619
Sinusitis 23.95 19.72 3 15122 145925 64337682
Drug dose titration not performed 23.45 19.72 8 15117 675 64482932
Hyperammonaemia 23.27 19.72 19 15106 9885 64473722
Colon cancer 22.95 19.72 21 15104 12718 64470889
Hepatorenal syndrome 22.91 19.72 13 15112 3733 64479874
Upper respiratory tract inflammation 22.80 19.72 13 15112 3769 64479838
Hypersensitivity 22.42 19.72 9 15116 196443 64287164
Anxiety 21.98 19.72 10 15115 202639 64280968
Pneumonia aspiration 21.80 19.72 45 15080 59226 64424381
Hepatocellular carcinoma 21.61 19.72 17 15108 8386 64475221
Iron deficiency anaemia 21.33 19.72 26 15099 21863 64461744
Urine osmolarity increased 21.22 19.72 6 15119 271 64483336
Human chorionic gonadotropin positive 20.33 19.72 4 15121 35 64483572
Pulmonary vein occlusion 20.27 19.72 5 15120 132 64483475
Asthenia 20.19 19.72 44 15081 428000 64055607

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C03XA01 CARDIOVASCULAR SYSTEM
DIURETICS
OTHER DIURETICS
Vasopressin antagonists
MeSH PA D065092 Antidiuretic Hormone Receptor Antagonists
MeSH PA D045283 Natriuretic Agents
FDA MoA N0000193178 Vasopressin V2 Receptor Antagonists
FDA EPC N0000193181 Vasopressin V2 Receptor Antagonist
CHEBI has role CHEBI:59680 vasopressin receptor antagonists

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Polycystic kidney disease, adult type indication 28728008
Syndrome of inappropriate vasopressin secretion indication 55004003 DOID:3401
Hyponatremia indication 89627008
Nutritional disorder contraindication 2492009 DOID:374
Alcoholism contraindication 7200002
Hyperkalemia contraindication 14140009
Cirrhosis of liver contraindication 19943007 DOID:5082
Hypovolemia contraindication 28560003
Demyelination contraindication 32693004
Dehydration contraindication 34095006
Hepatic failure contraindication 59927004
Gastrointestinal hemorrhage contraindication 74474003




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.1 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
15MG TOLVAPTAN PAR PHARM INC A206119 Feb. 15, 2022 RX TABLET ORAL Sept. 6, 2022 PATENT CHALLENGE
15MG JYNARQUE OTSUKA N204441 April 23, 2018 RX TABLET ORAL April 23, 2025 INDICATED TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS AT RISK OF RAPIDLY PROGRESSING AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
30MG JYNARQUE OTSUKA N204441 April 23, 2018 RX TABLET ORAL April 23, 2025 INDICATED TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS AT RISK OF RAPIDLY PROGRESSING AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
45MG JYNARQUE OTSUKA N204441 April 23, 2018 RX TABLET ORAL April 23, 2025 INDICATED TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS AT RISK OF RAPIDLY PROGRESSING AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
60MG JYNARQUE OTSUKA N204441 April 23, 2018 RX TABLET ORAL April 23, 2025 INDICATED TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS AT RISK OF RAPIDLY PROGRESSING AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
90MG JYNARQUE OTSUKA N204441 April 23, 2018 RX TABLET ORAL April 23, 2025 INDICATED TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS AT RISK OF RAPIDLY PROGRESSING AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Vasopressin V2 receptor GPCR ANTAGONIST Ki 9 WOMBAT-PK DRUG LABEL
Vasopressin V1a receptor GPCR ANTAGONIST Ki 7.90 IUPHAR
Vasopressin V2 receptor GPCR ANTAGONIST Ki 8.90 IUPHAR
Vasopressin V1a receptor GPCR ANTAGONIST Ki 6.50 IUPHAR

External reference:

IDSource
4028789 VUID
N0000178481 NUI
D01213 KEGG_DRUG
4028789 VANDF
C1176308 UMLSCUI
CHEBI:32246 CHEBI
CHEMBL344159 ChEMBL_ID
D000077602 MESH_DESCRIPTOR_UI
DB06212 DRUGBANK_ID
2226 IUPHAR_LIGAND_ID
7969 INN_ID
21G72T1950 UNII
216237 PUBCHEM_CID
358257 RXNORM
165174 MMSL
26477 MMSL
334368 MMSL
d07447 MMSL
013121 NDDF
442901006 SNOMEDCT_US
443058000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Tolvaptan HUMAN PRESCRIPTION DRUG LABEL 1 31722-869 TABLET 30 mg ORAL ANDA 28 sections
Tolvaptan HUMAN PRESCRIPTION DRUG LABEL 1 49884-768 TABLET 15 mg ORAL ANDA 28 sections
Tolvaptan HUMAN PRESCRIPTION DRUG LABEL 1 49884-770 TABLET 30 mg ORAL ANDA 28 sections
SAMSCA HUMAN PRESCRIPTION DRUG LABEL 1 59148-020 TABLET 15 mg ORAL NDA 33 sections
SAMSCA HUMAN PRESCRIPTION DRUG LABEL 1 59148-021 TABLET 30 mg ORAL NDA 33 sections
JYNARQUE HUMAN PRESCRIPTION DRUG LABEL 1 59148-082 TABLET 15 mg ORAL NDA 32 sections
JYNARQUE HUMAN PRESCRIPTION DRUG LABEL 1 59148-083 TABLET 30 mg ORAL NDA 32 sections
TOLVAPTAN HUMAN PRESCRIPTION DRUG LABEL 1 60505-4704 TABLET 15 mg ORAL NDA 33 sections
TOLVAPTAN HUMAN PRESCRIPTION DRUG LABEL 1 60505-4705 TABLET 30 mg ORAL NDA 33 sections
Tolvaptan Human Prescription Drug Label 1 67877-636 TABLET 30 mg ORAL ANDA 28 sections
Tolvaptan Human Prescription Drug Label 1 67877-636 TABLET 30 mg ORAL ANDA 28 sections
Tolvaptan Human Prescription Drug Label 1 67877-637 TABLET 60 mg ORAL ANDA 28 sections
Tolvaptan Human Prescription Drug Label 1 67877-637 TABLET 60 mg ORAL ANDA 28 sections