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

Stem definitionDrug idCAS RN
aromatic ring -CH(-OH)-CH2-NH-R 2464 3930-20-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • sotalol
  • DL-Sotalol
  • sotalol hydrochloride
  • sotylize
  • sotalol HCl
An adrenergic beta-antagonist that is used in the treatment of life-threatening arrhythmias.
  • Molecular weight: 272.36
  • Formula: C12H20N2O3S
  • CLOGP: 0.23
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 3
  • TPSA: 78.43
  • ALOGS: -2.54
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.16 g O
0.16 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 137 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 85 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 19.57 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 95 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.62 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 6.30 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Oct. 30, 1992 FDA COVIS PHARMA SARL

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
Torsade de pointes 268.16 14.81 102 11844 11733 50581445
Atrial fibrillation 217.80 14.81 185 11761 101560 50491618
Electrocardiogram QT prolonged 180.48 14.81 126 11820 51760 50541418
Bradycardia 109.56 14.81 103 11843 64323 50528855
Drug interaction 90.75 14.81 166 11780 199455 50393723
International normalised ratio increased 83.10 14.81 74 11872 43078 50550100
Hyponatraemia 69.77 14.81 99 11847 96040 50497138
Arrhythmia 64.14 14.81 57 11889 33075 50560103
Ventricular tachycardia 63.44 14.81 42 11904 15779 50577399
Hypotension 56.88 14.81 152 11794 235317 50357861
Urinary incontinence 51.57 14.81 47 11899 28161 50565017
Atrial tachycardia 50.51 14.81 19 11927 2113 50591065
Hyperkalaemia 48.04 14.81 58 11888 48031 50545147
Ischaemic stroke 46.84 14.81 35 11911 15913 50577265
Sinus bradycardia 43.41 14.81 31 11915 13152 50580026
Erythromelalgia 42.10 14.81 9 11937 122 50593056
Cardiac arrest 41.01 14.81 72 11874 83579 50509599
Cardiac disorder 38.37 14.81 49 11897 42930 50550248
Hepatocellular injury 37.53 14.81 38 11908 25909 50567269
Asthenia 36.94 14.81 161 11785 318881 50274297
Cardio-respiratory arrest 36.86 14.81 54 11892 53838 50539340
Cerebral haematoma 36.64 14.81 17 11929 3194 50589984
Syncope 36.19 14.81 77 11869 102925 50490253
Palpitations 35.96 14.81 73 11873 94433 50498745
Inappropriate antidiuretic hormone secretion 34.54 14.81 27 11919 13116 50580062
Atrial flutter 34.49 14.81 23 11923 8740 50584438
Atrioventricular block 32.96 14.81 20 11926 6458 50586720
Apallic syndrome 32.19 14.81 10 11936 623 50592555
Bundle branch block left 31.10 14.81 19 11927 6211 50586967
Presyncope 30.62 14.81 33 11913 24165 50569013
Localised oedema 29.96 14.81 17 11929 4850 50588328
Long QT syndrome 28.64 14.81 14 11932 2953 50590225
Acute kidney injury 28.61 14.81 118 11828 227940 50365238
Ventricular fibrillation 28.42 14.81 22 11924 10537 50582641
Malaise 26.51 14.81 152 11794 335380 50257798
Subdural haematoma 26.49 14.81 23 11923 12924 50580254
Melaena 26.17 14.81 32 11914 26832 50566346
Organising pneumonia 24.96 14.81 15 11931 4759 50588419
Gastrointestinal haemorrhage 24.81 14.81 54 11892 73267 50519911
Ventricular arrhythmia 24.34 14.81 13 11933 3296 50589882
Pain 24.33 14.81 64 11882 578839 50014339
Nasal mucosal erosion 23.30 14.81 5 11941 69 50593109
Cardiac ablation 21.76 14.81 9 11937 1285 50591893
Haematoma 21.47 14.81 31 11915 30479 50562699
Electrocardiogram QRS complex prolonged 20.96 14.81 14 11932 5330 50587848
Cardiac failure congestive 20.83 14.81 55 11891 84327 50508851
Joint swelling 20.14 14.81 17 11929 245269 50347909
Loss of consciousness 19.92 14.81 62 11884 104291 50488887
Hypoglycaemia 19.90 14.81 41 11905 53540 50539638
Rheumatoid arthritis 19.28 14.81 12 11934 202538 50390640
Systemic lupus erythematosus 18.76 14.81 5 11941 140617 50452561
Noninfective gingivitis 18.72 14.81 8 11938 1238 50591940
Drug intolerance 18.21 14.81 15 11931 219089 50374089
Arthropathy 17.00 14.81 8 11938 157898 50435280
Contraindicated product administered 16.90 14.81 7 11939 148951 50444227
Haemorrhagic stroke 16.53 14.81 12 11934 5216 50587962
Fall 16.42 14.81 135 11811 334797 50258381
Medication error 16.30 14.81 30 11916 36074 50557104
Transient ischaemic attack 16.12 14.81 28 11918 32182 50560996
Cerebral congestion 16.08 14.81 3 11943 19 50593159
Subarachnoid haemorrhage 15.97 14.81 16 11930 10760 50582418
Optic nerve infarction 15.82 14.81 3 11943 21 50593157
Blood loss anaemia 15.73 14.81 14 11932 8125 50585053
Wound 15.64 14.81 3 11943 105791 50487387
Resting tremor 15.51 14.81 6 11940 720 50592458
Blood pressure increased 15.20 14.81 67 11879 133065 50460113
Cerebrovascular accident 15.15 14.81 53 11893 94627 50498551
Normocytic anaemia 15.06 14.81 7 11939 1320 50591858
Acute pulmonary oedema 15.05 14.81 13 11933 7254 50585924

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
Atrial fibrillation 188.50 14.01 219 11376 105427 29457505
Bradycardia 116.70 14.01 136 11459 65493 29497439
Ventricular tachycardia 102.99 14.01 79 11516 22495 29540437
Electrocardiogram QT prolonged 94.55 14.01 92 11503 36045 29526887
Torsade de pointes 88.65 14.01 46 11549 6615 29556317
Cardiogenic shock 60.05 14.01 54 11541 19136 29543796
Atrial flutter 57.66 14.01 46 11549 13848 29549084
Palpitations 53.61 14.01 65 11530 32539 29530393
Apallic syndrome 40.99 14.01 11 11584 240 29562692
Atrial thrombosis 39.26 14.01 18 11577 1975 29560957
Drug interaction 39.19 14.01 167 11428 197218 29365714
Hypotension 39.02 14.01 165 11430 194189 29368743
Antiacetylcholine receptor antibody positive 38.40 14.01 8 11587 54 29562878
Pacemaker generated rhythm 37.43 14.01 8 11587 62 29562870
Ventricular arrhythmia 37.36 14.01 23 11572 4581 29558351
Cardiac ablation 37.13 14.01 13 11582 704 29562228
Arrhythmia 36.87 14.01 53 11542 31260 29531672
Staring 35.40 14.01 15 11580 1364 29561568
Daydreaming 33.90 14.01 11 11584 471 29562461
Ischaemic stroke 33.26 14.01 36 11559 15941 29546991
Haemoptysis 32.07 14.01 49 11546 30501 29532431
International normalised ratio increased 31.76 14.01 60 11535 44312 29518620
Petit mal epilepsy 31.14 14.01 17 11578 2705 29560227
Pallor 29.90 14.01 39 11556 20985 29541947
Incontinence 28.31 14.01 20 11575 5012 29557920
Loss of consciousness 28.22 14.01 78 11517 73978 29488954
Dissociation 28.05 14.01 12 11583 1117 29561815
Long QT syndrome 25.55 14.01 14 11581 2244 29560688
Presyncope 24.69 14.01 31 11564 16058 29546874
Xanthopsia 21.73 14.01 6 11589 146 29562786
Heart rate abnormal 21.08 14.01 11 11584 1598 29561334
Cardiac disorder 20.27 14.01 45 11550 37218 29525714
Drug abuse 19.12 14.01 4 11591 79879 29483053
Rectal haemorrhage 17.99 14.01 41 11554 34508 29528424
Acquired haemophilia 17.83 14.01 8 11587 835 29562097
Grandiosity 17.30 14.01 6 11589 316 29562616
Ventricular fibrillation 16.05 14.01 25 11570 15808 29547124
Brugada syndrome 15.94 14.01 7 11588 694 29562238
Haematuria 15.34 14.01 45 11550 44094 29518838
Cardiac failure congestive 15.28 14.01 65 11530 76516 29486416
Pressure of speech 15.24 14.01 6 11589 452 29562480
Dyspnoea 15.23 14.01 195 11400 326537 29236395
Pyrexia 15.03 14.01 60 11535 287562 29275370
Food interaction 14.27 14.01 7 11588 893 29562039
Gingival bleeding 14.23 14.01 15 11580 6438 29556494
Venous pressure increased 14.18 14.01 3 11592 22 29562910
Cardiac failure 14.08 14.01 65 11530 79222 29483710

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
Torsade de pointes 340.16 12.98 147 20548 17216 64460821
Atrial fibrillation 327.72 12.98 335 20360 170754 64307283
Electrocardiogram QT prolonged 252.83 12.98 207 20488 79241 64398796
Bradycardia 210.78 12.98 223 20472 117996 64360041
Ventricular tachycardia 159.21 12.98 112 20583 34153 64443884
Drug interaction 114.33 12.98 313 20382 361770 64116267
International normalised ratio increased 96.65 12.98 123 20572 79044 64398993
Atrial flutter 91.51 12.98 64 20631 19316 64458721
Arrhythmia 82.24 12.98 93 20602 52851 64425186
Ischaemic stroke 80.58 12.98 70 20625 28965 64449072
Hypotension 78.29 12.98 284 20411 380690 64097347
Palpitations 74.55 12.98 126 20569 104362 64373675
Cardiogenic shock 72.03 12.98 69 20626 32358 64445679
Apallic syndrome 65.97 12.98 20 20675 839 64477198
Ventricular arrhythmia 61.51 12.98 35 20660 7380 64470657
Long QT syndrome 52.96 12.98 28 20667 5111 64472926
Atrial thrombosis 50.66 12.98 23 20672 3019 64475018
Loss of consciousness 47.36 12.98 129 20566 148236 64329801
Syncope 44.40 12.98 131 20564 157504 64320533
Cardiac ablation 41.34 12.98 17 20678 1755 64476282
Antiacetylcholine receptor antibody positive 39.14 12.98 8 20687 61 64477976
Ventricular fibrillation 38.89 12.98 43 20652 23817 64454220
Pacemaker generated rhythm 38.69 12.98 8 20687 65 64477972
Cardiac arrest 38.69 12.98 123 20572 153941 64324096
Inappropriate antidiuretic hormone secretion 37.78 12.98 41 20654 22248 64455789
Cardiac disorder 36.75 12.98 65 20630 55751 64422286
Erythromelalgia 36.06 12.98 9 20686 180 64477857
Sinus bradycardia 35.16 12.98 40 20655 22853 64455184
Cerebral haematoma 34.54 12.98 24 20671 7161 64470876
Presyncope 34.36 12.98 49 20646 35040 64442997
Haemoptysis 33.44 12.98 58 20637 48990 64429047
Acute kidney injury 33.20 12.98 252 20443 448988 64029049
Rectal haemorrhage 32.04 12.98 65 20630 61752 64416285
Haemorrhagic stroke 31.73 12.98 26 20669 9925 64468112
Asthenia 31.56 12.98 240 20455 427804 64050233
Hyponatraemia 31.54 12.98 112 20583 148227 64329810
Daydreaming 30.46 12.98 11 20684 799 64477238
Urinary incontinence 30.39 12.98 47 20648 36104 64441933
Staring 30.26 12.98 15 20680 2395 64475642
Atrial tachycardia 30.06 12.98 17 20678 3542 64474495
Cardiac failure congestive 28.97 12.98 100 20595 130480 64347557
Subdural haematoma 27.20 12.98 39 20656 28015 64450022
Gastrointestinal haemorrhage 24.85 12.98 96 20599 132216 64345821
Petit mal epilepsy 24.64 12.98 17 20678 5015 64473022
Joint swelling 24.37 12.98 20 20675 215362 64262675
Pain 23.96 12.98 94 20601 553417 63924620
Organising pneumonia 23.45 12.98 21 20674 9034 64469003
Arthralgia 23.28 12.98 69 20626 442191 64035846
Haematoma 23.21 12.98 48 20647 46202 64431835
Cardio-respiratory arrest 22.39 12.98 76 20619 98317 64379720
Sinus node dysfunction 22.11 12.98 18 20677 6810 64471227
Hyperkalaemia 22.04 12.98 77 20618 101052 64376985
Medication error 21.80 12.98 49 20646 49917 64428120
Nasal mucosal erosion 21.77 12.98 5 20690 69 64477968
Dissociation 21.76 12.98 13 20682 2998 64475039
Melaena 21.70 12.98 51 20644 53497 64424540
Pallor 21.56 12.98 42 20653 38739 64439298
Malaise 21.19 12.98 207 20488 396040 64081997
Transient ischaemic attack 20.03 12.98 44 20651 44138 64433899
Fall 19.55 12.98 212 20483 416614 64061423
Blood loss anaemia 19.21 12.98 23 20672 13869 64464168
Acute pulmonary oedema 19.03 12.98 22 20673 12787 64465250
Left ventricular failure 18.85 12.98 18 20677 8399 64469638
Xanthopsia 18.64 12.98 6 20689 307 64477730
Incontinence 18.37 12.98 21 20674 12060 64465977
Cerebrovascular accident 18.31 12.98 90 20605 137493 64340544
Hepatocellular injury 18.24 12.98 43 20652 45192 64432845
Rheumatoid arthritis 17.67 12.98 16 20679 164278 64313759
Shock haemorrhagic 17.25 12.98 24 20671 16767 64461270
Atrioventricular block 16.79 12.98 20 20675 11995 64466042
Cardioversion 15.91 12.98 9 20686 1876 64476161
Dizziness 15.86 12.98 209 20486 429954 64048083
Hyperthyroidism 15.79 12.98 24 20671 18155 64459882
Junctional ectopic tachycardia 15.76 12.98 3 20692 15 64478022
Noninfective gingivitis 15.74 12.98 8 20687 1346 64476691
Localised oedema 15.39 12.98 15 20680 7176 64470861
Grandiosity 15.18 12.98 6 20689 559 64477478
Haematuria 14.90 12.98 48 20647 60423 64417614
Pressure of speech 14.89 12.98 7 20688 994 64477043
Haemorrhage intracranial 14.68 12.98 27 20668 23857 64454180
Cardiac failure 14.46 12.98 82 20613 132291 64345746
Brugada syndrome 14.40 12.98 7 20688 1071 64476966
Acquired haemophilia 14.39 12.98 8 20687 1612 64476425
Venous pressure increased 14.24 12.98 3 20692 27 64478010
Endodontic procedure 14.17 12.98 9 20686 2314 64475723
Mobility decreased 14.02 12.98 5 20690 85835 64392202
Atrioventricular block first degree 13.59 12.98 17 20678 10717 64467320
Hypoglycaemia 13.56 12.98 61 20634 89831 64388206
Intraventricular haemorrhage 13.55 12.98 11 20684 4142 64473895
Prothrombin time ratio decreased 13.37 12.98 6 20689 767 64477270
Injection site pain 13.02 12.98 10 20685 111398 64366639
Cerebral haemorrhage 12.99 12.98 41 20654 51049 64426988

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C07AA07 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS
Beta blocking agents, non-selective
ATC C07BA07 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS AND THIAZIDES
Beta blocking agents, non-selective, and thiazides
ATC C07FX02 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS, OTHER COMBINATIONS
Beta blocking agents, other combinations
FDA MoA N0000000161 Adrenergic beta-Antagonists
FDA PE N0000008330 Cardiac Rhythm Alteration
FDA EPC N0000175426 Antiarrhythmic
MeSH PA D018663 Adrenergic Agents
MeSH PA D018674 Adrenergic Antagonists
MeSH PA D000319 Adrenergic beta-Antagonists
MeSH PA D000889 Anti-Arrhythmia Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D013565 Sympatholytics
CHEBI has role CHEBI:35530 beta-adrenergic blockers
CHEBI has role CHEBI:38070 antiarrhythmic agent
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:78298 environmental contaminants

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

DiseaseRelationSNOMED_IDDOID
Atrial fibrillation indication 49436004 DOID:0060224
Life-Threatening Ventricular Tachycardia indication
Bronchospasm contraindication 4386001
Complete atrioventricular block contraindication 27885002
Torsades de pointes contraindication 31722008
Sick sinus syndrome contraindication 36083008 DOID:13884
Anaphylaxis contraindication 39579001
Hypokalemia contraindication 43339004
Low blood pressure contraindication 45007003
Sinus bradycardia contraindication 49710005
Diabetes mellitus contraindication 73211009 DOID:9351
Cardiogenic shock contraindication 89138009
Prolonged QT interval contraindication 111975006
Hypomagnesemia contraindication 190855004
Second degree atrioventricular block contraindication 195042002
Decompensated cardiac failure contraindication 195111005
Asthma contraindication 195967001 DOID:2841
Impaired renal function disorder contraindication 197663003
Pregnancy, function contraindication 289908002
Congenital long QT syndrome contraindication 442917000




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 9.95 acidic
pKa2 9.22 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
5MG/ML (5MG/ML) SOTYLIZE AZURITY N205108 Oct. 22, 2014 RX SOLUTION ORAL 10206895 April 1, 2034 INDICATED FOR THE TREATMENT OF VENTRICULAR ARRHYTHMIAS, SUCH AS SUSTAINED VENTRICULAR TACHYCARDIA, THAT IN THE JUDGEMENT OF THE PHYSICIAN ARE LIFE-THREATENING
5MG/ML (5MG/ML) SOTYLIZE AZURITY N205108 Oct. 22, 2014 RX SOLUTION ORAL 10206895 April 1, 2034 SOTYLIZE IS INDICATED FOR THE MAINTENANCE OF NORMAL SINUS RHYTHM [DELAY IN TIME TO RECURRENCE OF ATRIAL FIBRILLATION/ATRIAL FLUTTER (AFIB/AFL)] IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM
5MG/ML (5MG/ML) SOTYLIZE AZURITY N205108 Oct. 22, 2014 RX SOLUTION ORAL 9724297 Aug. 31, 2035 SOTYLIZE IS INDICATED FOR THE MAINTENANCE OF NORMAL SINUS RHYTHM [DELAY IN TIME TO RECURRENCE OF ATRIAL FIBRILLATION/ATRIAL FLUTTER (AFIB/AFL)] IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM
150MG/10ML (15MG/ML) SOTALOL HYDROCHLORIDE ALTATHERA PHARMS LLC N022306 July 2, 2009 RX SOLUTION INTRAVENOUS 10512620 Aug. 18, 2038 DOSING REGIMEN FOR INTRAVENOUS SOTALOL FOR ADMINISTRATION IN A FACILITY THAT CAN PROVIDE CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING AND CARDIAC RESUSCITATION.
150MG/10ML (15MG/ML) SOTALOL HYDROCHLORIDE ALTATHERA PHARMS LLC N022306 July 2, 2009 RX SOLUTION INTRAVENOUS 10799138 April 5, 2039 USE FOR LOADING DOSE IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM OR FOR THE TREATMENT OF LIFE-THREATENING VENTRICULAR TACHYCARDIA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Beta-1 adrenergic receptor GPCR ANTAGONIST Ki 6.10 WOMBAT-PK CHEMBL
Beta-2 adrenergic receptor GPCR ANTAGONIST Ki 6.90 WOMBAT-PK CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel BLOCKER Ki 4 WOMBAT-PK CHEMBL
Beta-2 adrenergic receptor GPCR Kd 6.24 CHEMBL
Beta-2 adrenergic receptor GPCR IC50 5.30 CHEMBL

External reference:

IDSource
4020814 VUID
N0000148334 NUI
D01026 KEGG_DRUG
959-24-0 SECONDARY_CAS_RN
4020779 VANDF
4020814 VANDF
C0037707 UMLSCUI
CHEBI:63622 CHEBI
CHEMBL471 ChEMBL_ID
DB00489 DRUGBANK_ID
CHEMBL1700 ChEMBL_ID
D013015 MESH_DESCRIPTOR_UI
5253 PUBCHEM_CID
7297 IUPHAR_LIGAND_ID
2350 INN_ID
A6D97U294I UNII
1593726 RXNORM
230116 MMSL
31427 MMSL
5503 MMSL
d00371 MMSL
003453 NDDF
004111 NDDF
125691000 SNOMEDCT_US
372911006 SNOMEDCT_US
96301002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-1060 TABLET 120 mg ORAL ANDA 25 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-1061 TABLET 80 mg ORAL ANDA 25 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-1062 TABLET 160 mg ORAL ANDA 25 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-1063 TABLET 240 mg ORAL ANDA 25 sections
Sorine HUMAN PRESCRIPTION DRUG LABEL 1 0245-0012 TABLET 80 mg ORAL ANDA 28 sections
Sorine HUMAN PRESCRIPTION DRUG LABEL 1 0245-0013 TABLET 120 mg ORAL ANDA 28 sections
Sorine HUMAN PRESCRIPTION DRUG LABEL 1 0245-0014 TABLET 160 mg ORAL ANDA 28 sections
Sorine HUMAN PRESCRIPTION DRUG LABEL 1 0245-0015 TABLET 240 mg ORAL ANDA 28 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-5552 TABLET 80 mg ORAL ANDA 24 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7143 TABLET 80 mg ORAL ANDA 25 sections
Sotalol HUMAN PRESCRIPTION DRUG LABEL 1 10135-661 TABLET 80 mg ORAL ANDA 24 sections
Sotalol HUMAN PRESCRIPTION DRUG LABEL 1 10135-662 TABLET 120 mg ORAL ANDA 24 sections
Sotalol HUMAN PRESCRIPTION DRUG LABEL 1 10135-663 TABLET 160 mg ORAL ANDA 24 sections
Sotalol HydrochlorideAF HUMAN PRESCRIPTION DRUG LABEL 1 10135-715 TABLET 80 mg ORAL ANDA 24 sections
Sotalol HydrochlorideAF HUMAN PRESCRIPTION DRUG LABEL 1 10135-716 TABLET 120 mg ORAL ANDA 24 sections
Sotalol HydrochlorideAF HUMAN PRESCRIPTION DRUG LABEL 1 10135-717 TABLET 160 mg ORAL ANDA 24 sections
sotalol hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-397 TABLET 80 mg ORAL ANDA 19 sections
SOTYLIZE HUMAN PRESCRIPTION DRUG LABEL 1 24338-530 SOLUTION 5 mg ORAL NDA 29 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42806-121 TABLET 80 mg ORAL ANDA 14 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42806-122 TABLET 120 mg ORAL ANDA 14 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42806-123 TABLET 160 mg ORAL ANDA 14 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43353-616 TABLET 80 mg ORAL ANDA 25 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-1299 TABLET 80 mg ORAL ANDA 25 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50268-724 TABLET 80 mg ORAL ANDA 25 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50268-725 TABLET 120 mg ORAL ANDA 25 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 53217-011 TABLET 80 mg ORAL ANDA 21 sections
sotalol hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 54868-4435 TABLET 80 mg ORAL ANDA 19 sections
sotalol hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 54868-5549 TABLET 160 mg ORAL ANDA 19 sections
sotalol hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 54868-5614 TABLET 120 mg ORAL ANDA 19 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 55154-8179 TABLET 80 mg ORAL ANDA 25 sections