glycopyrronium bromide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4302 596-51-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • sialanar
  • NVA237
  • Seebri Breezhaler
  • glycopyrronium bromide
  • copyrrolate
  • gastrodyn
  • glycopyrrolate
  • robanul
  • glycopyrronium
  • glycopyrrolate bromide
  • glycopyrronium tosilate
  • glycopyrronium tosilate hydrate
Glycopyrrolate is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo studies, prevention of methacholine and acetylcholine induced bronchoconstrictive effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown. The bronchodilation following inhalation of glycopyrrolate is predominantly a site-specific effect.
  • Molecular weight: 318.44
  • Formula: C19H28NO3
  • CLOGP: 0.12
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 46.53
  • ALOGS: -5.57
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
3 mg O
0.30 mg P
3 mg R
44 mcg Inhal.powder

ADMET properties:

PropertyValueReference
BA (Bioavailability) 17 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.37 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 16.80 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.65 hours Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.48 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

DateAgencyCompanyOrphan
Aug. 11, 1961 FDA SHIONOGI INC
June 18, 2019 PMDA AstraZeneca K.K.
Sept. 28, 2012 EMA Novartis Europharm Limited

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
Asthma 518.72 16.95 362 17223 127199 63344238
Wheezing 493.89 16.95 315 17270 95280 63376157
Total lung capacity increased 316.80 16.95 82 17503 2228 63469209
Obstructive airways disorder 307.21 16.95 138 17447 20561 63450876
Bronchiectasis 228.02 16.95 104 17481 16038 63455399
Cough 224.62 16.95 336 17249 292407 63179030
Dyspnoea 219.76 16.95 530 17055 660783 62810654
Asthma-chronic obstructive pulmonary disease overlap syndrome 215.32 16.95 59 17526 2002 63469435
Forced expiratory volume decreased 210.50 16.95 71 17514 4897 63466540
Nasal congestion 202.33 16.95 158 17427 65502 63405935
Nasal polyps 189.46 16.95 69 17516 5970 63465467
Blood immunoglobulin E increased 187.03 16.95 61 17524 3788 63467649
Chronic obstructive pulmonary disease 170.02 16.95 140 17445 62546 63408891
Malignant mediastinal neoplasm 163.22 16.95 44 17541 1402 63470035
Sputum discoloured 148.71 16.95 78 17507 16269 63455168
Sarcoidosis 140.16 16.95 58 17527 7064 63464373
Productive cough 132.67 16.95 122 17463 63086 63408351
Respiration abnormal 132.20 16.95 54 17531 6363 63465074
Full blood count abnormal 130.72 16.95 91 17494 31626 63439811
Bronchial neoplasm 126.15 16.95 29 17556 471 63470966
Sleep disorder due to a general medical condition 124.85 16.95 63 17522 12125 63459312
Lung neoplasm malignant 124.76 16.95 74 17511 19559 63451878
Bronchial haemorrhage 121.27 16.95 29 17556 563 63470874
Sleep apnoea syndrome 116.36 16.95 82 17503 29051 63442386
Rhinitis allergic 115.41 16.95 59 17526 11668 63459769
Nasal turbinate hypertrophy 113.96 16.95 29 17556 734 63470703
Bronchial disorder 107.74 16.95 31 17554 1259 63470178
Endometrial ablation 107.24 16.95 29 17556 935 63470502
Hyper IgE syndrome 104.56 16.95 25 17560 485 63470952
Rhinorrhoea 102.93 16.95 108 17477 65469 63405968
Cardiac murmur 100.77 16.95 58 17527 14494 63456943
Chest discomfort 96.77 16.95 135 17450 109834 63361603
Glaucoma 96.56 16.95 62 17523 18843 63452594
Restrictive pulmonary disease 93.52 16.95 30 17555 1765 63469672
Heart sounds 87.96 16.95 25 17560 971 63470466
Rhonchi 86.66 16.95 31 17554 2545 63468892
Prolonged expiration 85.60 16.95 25 17560 1071 63470366
Humidity intolerance 80.75 16.95 19 17566 343 63471094
Hypomania 77.62 16.95 37 17548 6293 63465144
Pain 77.07 16.95 56 17529 740572 62730865
Pneumonia 76.17 16.95 288 17297 456479 63014958
Peak expiratory flow rate decreased 75.05 16.95 20 17565 609 63470828
Jaundice cholestatic 72.50 16.95 37 17548 7287 63464150
Alopecia 71.23 16.95 6 17579 337530 63133907
Rhinitis 67.43 16.95 41 17544 11325 63460112
Secretion discharge 67.17 16.95 42 17543 12189 63459248
Schizophrenia 67.13 16.95 39 17546 9913 63461524
Lower respiratory tract infection 65.25 16.95 125 17460 132182 63339255
Breast cancer recurrent 64.53 16.95 29 17556 4312 63467125
Dyspnoea exertional 59.02 16.95 78 17507 60224 63411213
Granuloma 56.72 16.95 29 17556 5732 63465705
Infusion related reaction 55.76 16.95 3 17582 245518 63225919
Affective disorder 54.95 16.95 29 17556 6117 63465320
Therapeutic product effect incomplete 54.25 16.95 112 17473 124944 63346493
Gastrooesophageal reflux disease 54.24 16.95 96 17489 95543 63375894
Frustration tolerance decreased 54.18 16.95 30 17555 6958 63464479
Rales 53.62 16.95 37 17548 12660 63458777
Breath sounds abnormal 53.60 16.95 35 17550 10938 63460499
Depressive symptom 53.43 16.95 25 17560 4077 63467360
Arthropathy 52.91 16.95 3 17582 234789 63236648
Polycystic ovaries 51.38 16.95 25 17560 4446 63466991
Pulmonary function test decreased 51.24 16.95 24 17561 3923 63467514
Joint swelling 50.76 16.95 14 17571 327652 63143785
Drug intolerance 50.08 16.95 12 17573 308649 63162788
Rash 48.98 16.95 50 17535 560821 62910616
Forced vital capacity decreased 47.99 16.95 16 17569 1063 63470374
Appetite disorder 47.56 16.95 28 17557 7293 63464144
Lung diffusion test decreased 46.15 16.95 14 17571 684 63470753
Rheumatoid arthritis 42.91 16.95 9 17576 253810 63217627
Middle insomnia 42.32 16.95 32 17553 12611 63458826
Depression 42.25 16.95 135 17450 196357 63275080
Arthralgia 41.03 16.95 59 17526 569651 62901786
Treatment failure 40.71 16.95 4 17581 199039 63272398
Dyslipidaemia 39.62 16.95 25 17560 7368 63464069
Therapeutic product effect decreased 39.20 16.95 4 17581 193183 63278254
Oxygen saturation decreased 39.17 16.95 80 17505 88505 63382932
Systemic lupus erythematosus 38.34 16.95 6 17579 208912 63262525
Choking 37.56 16.95 27 17558 9852 63461585
Nail dystrophy 36.78 16.95 13 17572 1030 63470407
Diarrhoea 36.66 16.95 91 17494 715275 62756162
Sinus tachycardia 36.32 16.95 39 17546 24229 63447208
Psychotic disorder 36.18 16.95 40 17545 25672 63445765
Pulmonary thrombosis 35.90 16.95 25 17560 8677 63462760
Restless legs syndrome 35.44 16.95 34 17551 18497 63452940
Synovitis 35.15 16.95 5 17580 186913 63284524
Seizure 35.00 16.95 98 17487 132536 63338901
Body temperature abnormal 34.75 16.95 15 17570 2026 63469411
Influenza 34.45 16.95 86 17499 108636 63362801
Sneezing 34.04 16.95 33 17552 18185 63453252
Pulmonary congestion 33.39 16.95 32 17553 17386 63454051
Angioplasty 33.12 16.95 13 17572 1379 63470058
Nasal inflammation 32.78 16.95 10 17575 498 63470939
Blood test abnormal 32.42 16.95 30 17555 15599 63455838
Pulmonary oedema 32.28 16.95 56 17529 54817 63416620
Bronchospasm paradoxical 31.90 16.95 7 17578 91 63471346
Blood bilirubin increased 31.73 16.95 45 17540 37095 63434342
Brain injury 30.86 16.95 21 17564 7022 63464415
Coronary artery disease 30.32 16.95 41 17544 32336 63439101
Respiratory disorder 29.98 16.95 45 17540 39037 63432400
Staphylococcal scalded skin syndrome 29.87 16.95 7 17578 124 63471313
Abdominal discomfort 29.82 16.95 27 17558 320858 63150579
Axillary pain 28.69 16.95 13 17572 1970 63469467
Blood pressure systolic increased 27.39 16.95 48 17537 47349 63424088
Ankle fracture 27.26 16.95 29 17556 17826 63453611
Abscess 27.10 16.95 28 17557 16640 63454797
Tachycardia 27.04 16.95 83 17502 118073 63353364
Granulomatosis with polyangiitis 27.04 16.95 13 17572 2252 63469185
Swelling 27.01 16.95 22 17563 275356 63196081
Increased bronchial secretion 26.89 16.95 12 17573 1754 63469683
Vulvovaginal candidiasis 25.63 16.95 14 17571 3161 63468276
Staphylococcus test positive 25.56 16.95 15 17570 3881 63467556
Paranoia 25.36 16.95 23 17562 11656 63459781
Cholelithiasis 24.76 16.95 44 17541 43881 63427556
Drug ineffective 24.75 16.95 179 17406 1044586 62426851
Hepatotoxicity 24.71 16.95 40 17545 37001 63434436
Peripheral vascular disorder 24.11 16.95 17 17568 6018 63465419
Fatigue 24.10 16.95 146 17439 887882 62583555
Dystonia 23.90 16.95 24 17561 13795 63457642
Anaphylactic reaction 23.85 16.95 55 17530 66045 63405392
Dysphonia 23.45 16.95 45 17540 47569 63423868
Stress cardiomyopathy 23.30 16.95 20 17565 9430 63462007
Catheter site haemorrhage 22.90 16.95 13 17572 3162 63468275
Nasopharyngitis 22.74 16.95 134 17451 254123 63217314
Blood disorder 22.36 16.95 17 17568 6754 63464683
Respiratory symptom 22.26 16.95 13 17572 3334 63468103
Muscle disorder 22.21 16.95 15 17570 4954 63466483
Bronchial obstruction 22.18 16.95 10 17575 1497 63469940
Flank pain 22.18 16.95 25 17560 16385 63455052
Apnoea 21.89 16.95 18 17567 8004 63463433
Crepitations 21.85 16.95 18 17567 8022 63463415
Appendicitis 21.48 16.95 18 17567 8211 63463226
Blister 21.12 16.95 5 17580 129809 63341628
Cerebral thrombosis 21.08 16.95 10 17575 1681 63469756
Laryngospasm 20.77 16.95 12 17573 3016 63468421
Infective exacerbation of chronic obstructive airways disease 20.62 16.95 9 17576 1248 63470189
Bronchial wall thickening 19.10 16.95 9 17576 1490 63469947
Laryngitis fungal 19.09 16.95 5 17580 142 63471295
Opisthotonus 18.75 16.95 6 17579 350 63471087
Impaired healing 18.68 16.95 3 17582 102539 63368898
Oropharyngitis fungal 18.60 16.95 4 17581 47 63471390
Arthritis 18.30 16.95 72 17513 115849 63355588
Respiratory acidosis 18.18 16.95 15 17570 6700 63464737
Discomfort 18.17 16.95 12 17573 167362 63304075
White blood cell count decreased 17.98 16.95 8 17577 139096 63332341
Eosinophilic pneumonia chronic 17.62 16.95 5 17580 193 63471244
Respiratory failure 17.50 16.95 65 17520 101793 63369644
Loss of personal independence in daily activities 17.49 16.95 63 17522 97227 63374210
Seasonal allergy 17.33 16.95 25 17560 20925 63450512
Subretinal fluid 17.22 16.95 6 17579 456 63470981
Smoke sensitivity 17.17 16.95 6 17579 460 63470977
Neutropenia 17.12 16.95 14 17571 174991 63296446
Presbyopia 17.10 16.95 6 17579 465 63470972
Weight decreased 17.03 16.95 133 17452 276665 63194772
Atrioventricular dissociation 16.97 16.95 5 17580 221 63471216

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
Asthma 193.58 16.59 134 10408 42522 34903867
Wheezing 180.70 16.59 127 10415 41275 34905114
Dyspnoea 133.40 16.59 326 10216 376456 34569933
Productive cough 128.90 16.59 100 10442 37713 34908676
Obstructive airways disorder 118.95 16.59 68 10474 15426 34930963
Rhinitis perennial 97.09 16.59 22 10520 305 34946084
Sleep disorder due to a general medical condition 91.04 16.59 40 10502 5181 34941208
Chronic obstructive pulmonary disease 80.61 16.59 86 10456 48832 34897557
Cough 80.36 16.59 154 10388 149986 34796403
Sputum discoloured 78.55 16.59 41 10501 7771 34938618
Pulmonary function test abnormal 76.42 16.59 29 10513 2581 34943808
Chest discomfort 74.62 16.59 87 10455 54443 34891946
Adjustment disorder 72.86 16.59 23 10519 1178 34945211
Asthma-chronic obstructive pulmonary disease overlap syndrome 71.30 16.59 23 10519 1264 34945125
Forced expiratory volume decreased 70.66 16.59 29 10513 3174 34943215
Full blood count abnormal 64.92 16.59 50 10492 18618 34927771
Blood immunoglobulin E increased 62.87 16.59 25 10517 2521 34943868
Dyspnoea exertional 59.10 16.59 69 10473 43210 34903179
Serotonin syndrome 51.67 16.59 45 10497 19888 34926501
Loss of personal independence in daily activities 50.55 16.59 56 10486 33123 34913266
Bronchial hyperreactivity 50.07 16.59 19 10523 1690 34944699
Gastrooesophageal reflux disease 47.71 16.59 58 10484 37866 34908523
Angle closure glaucoma 44.56 16.59 15 10527 942 34945447
Therapeutic product effect incomplete 43.19 16.59 64 10478 50477 34895912
Breath sounds abnormal 41.83 16.59 26 10516 6855 34939534
Dyspnoea at rest 41.09 16.59 21 10521 3807 34942582
Respiratory disorder 37.36 16.59 37 10505 19227 34927162
Prolonged expiration 34.63 16.59 9 10533 227 34946162
Hypercholesterolaemia 31.62 16.59 24 10518 8738 34937651
Saliva altered 31.41 16.59 8 10534 186 34946203
Ischaemic cardiomyopathy 31.11 16.59 21 10521 6368 34940021
Umbilical hernia 29.26 16.59 18 10524 4659 34941730
Smoke sensitivity 28.58 16.59 7 10535 138 34946251
Infective exacerbation of chronic obstructive airways disease 28.49 16.59 13 10529 1838 34944551
Cardiorenal syndrome 28.48 16.59 10 10532 713 34945676
Sputum purulent 28.03 16.59 9 10533 487 34945902
Dyspnoea paroxysmal nocturnal 27.81 16.59 12 10530 1487 34944902
Salivary hypersecretion 27.55 16.59 22 10520 8622 34937767
Obesity 27.34 16.59 26 10516 12852 34933537
Hypoxia 26.33 16.59 54 10488 55041 34891348
Middle insomnia 25.36 16.59 19 10523 6783 34939606
Tachycardia 25.16 16.59 69 10473 84703 34861686
Discomfort 23.86 16.59 29 10513 18909 34927480
Pseudomonal sepsis 23.08 16.59 14 10528 3533 34942856
Precancerous condition 22.88 16.59 5 10537 58 34946331
Occupational exposure to air contaminants 22.84 16.59 6 10536 158 34946231
Accelerated idioventricular rhythm 22.63 16.59 6 10536 164 34946225
Physical deconditioning 22.36 16.59 10 10532 1349 34945040
Nasal polyps 21.96 16.59 12 10530 2491 34943898
Emphysema 21.70 16.59 20 10522 9505 34936884
Eosinophil count increased 21.50 16.59 19 10523 8553 34937836
Bradycardia 21.01 16.59 60 10482 75358 34871031
Hypoventilation 21.00 16.59 13 10529 3401 34942988
Forced vital capacity decreased 20.49 16.59 8 10534 768 34945621
Sneezing 20.34 16.59 15 10527 5227 34941162
Perfume sensitivity 19.93 16.59 5 10537 109 34946280
Off label use 19.78 16.59 63 10479 419461 34526928
Anxiety 19.41 16.59 70 10472 99358 34847031
Nasal congestion 19.39 16.59 29 10513 23028 34923361
Drug intolerance 19.19 16.59 50 10492 59520 34886869
Seasonal allergy 19.19 16.59 16 10526 6659 34939730
Appendicitis perforated 19.13 16.59 10 10532 1898 34944491
Eosinophilic granulomatosis with polyangiitis 18.75 16.59 10 10532 1977 34944412
Anaesthetic complication neurological 18.54 16.59 6 10536 333 34946056
Rhinorrhoea 18.41 16.59 30 10512 25638 34920751
Laryngospasm 18.25 16.59 9 10533 1512 34944877
Grunting 17.52 16.59 6 10536 397 34945992
Odynophagia 17.48 16.59 14 10528 5507 34940882
Toxicity to various agents 17.30 16.59 21 10521 200341 34746048

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
Asthma 644.45 15.45 449 25314 134646 79583979
Wheezing 575.59 15.45 396 25367 116268 79602357
Obstructive airways disorder 380.09 15.45 191 25572 31268 79687357
Total lung capacity increased 295.25 15.45 80 25683 2218 79716407
Dyspnoea 277.65 15.45 749 25014 856276 78862349
Cough 269.76 15.45 449 25314 366340 79352285
Asthma-chronic obstructive pulmonary disease overlap syndrome 255.56 15.45 77 25686 3144 79715481
Forced expiratory volume decreased 252.34 15.45 95 25668 7719 79710906
Productive cough 220.49 15.45 201 25562 88130 79630495
Blood immunoglobulin E increased 217.48 15.45 79 25684 5803 79712822
Chronic obstructive pulmonary disease 214.43 15.45 195 25568 85224 79633401
Sputum discoloured 208.16 15.45 113 25650 21630 79696995
Nasal congestion 204.47 15.45 181 25582 76371 79642254
Bronchiectasis 202.32 15.45 112 25651 22274 79696351
Full blood count abnormal 166.01 15.45 123 25640 40351 79678274
Nasal polyps 162.78 15.45 68 25695 7259 79711366
Malignant mediastinal neoplasm 152.88 15.45 43 25720 1372 79717253
Sleep disorder due to a general medical condition 141.66 15.45 76 25687 14201 79704424
Chest discomfort 136.25 15.45 194 25569 137850 79580775
Sarcoidosis 122.80 15.45 58 25705 8277 79710348
Bronchial neoplasm 121.24 15.45 29 25734 479 79718146
Rhinitis allergic 120.85 15.45 65 25698 12204 79706421
Respiration abnormal 117.23 15.45 55 25708 7733 79710892
Nasal turbinate hypertrophy 111.39 15.45 29 25734 686 79717939
Sleep apnoea syndrome 111.03 15.45 93 25670 36385 79682240
Rhinorrhoea 109.67 15.45 129 25634 75945 79642680
Prolonged expiration 107.82 15.45 32 25731 1239 79717386
Gastrooesophageal reflux disease 105.02 15.45 148 25615 104098 79614527
Endometrial ablation 105.01 15.45 29 25734 864 79717761
Dyspnoea exertional 100.41 15.45 132 25631 86941 79631684
Hyper IgE syndrome 97.93 15.45 25 25738 546 79718079
Glaucoma 94.62 15.45 66 25697 19695 79698930
Bronchial haemorrhage 93.81 15.45 29 25734 1291 79717334
Lung neoplasm malignant 93.26 15.45 75 25688 27717 79690908
Restrictive pulmonary disease 92.75 15.45 34 25729 2561 79716064
Breath sounds abnormal 92.38 15.45 60 25703 15924 79702701
Rhinitis perennial 88.59 15.45 21 25742 333 79718292
Bronchial disorder 86.70 15.45 32 25731 2457 79716168
Cardiac murmur 83.21 15.45 56 25707 15768 79702857
Heart sounds 80.54 15.45 24 25739 942 79717683
Rhonchi 78.20 15.45 34 25729 4002 79714623
Humidity intolerance 75.63 15.45 19 25744 388 79718237
Lower respiratory tract infection 75.01 15.45 143 25620 129077 79589548
Pain 67.44 15.45 77 25686 703725 79014900
Forced vital capacity decreased 66.63 15.45 24 25739 1719 79716906
Hypomania 66.10 15.45 37 25726 7507 79711118
Peak expiratory flow rate decreased 65.88 15.45 19 25744 664 79717961
Pneumonia 65.49 15.45 400 25363 659846 79058779
Pulmonary function test abnormal 64.64 15.45 30 25733 4114 79714511
Middle insomnia 61.77 15.45 47 25716 16022 79702603
Therapeutic product effect incomplete 60.25 15.45 138 25625 141507 79577118
Respiratory disorder 56.38 15.45 71 25692 44785 79673840
Secretion discharge 55.69 15.45 43 25720 14979 79703646
Pulmonary function test decreased 55.07 15.45 33 25730 7604 79711021
Rhinitis 54.05 15.45 42 25721 14765 79703860
Joint swelling 52.83 15.45 14 25749 288632 79429993
Jaundice cholestatic 52.41 15.45 37 25726 11247 79707378
Polycystic ovaries 51.71 15.45 25 25738 3754 79714871
Sneezing 49.44 15.45 45 25718 19638 79698987
Frustration tolerance decreased 47.92 15.45 30 25733 7472 79711153
Alopecia 46.78 15.45 9 25754 231346 79487279
Infusion related reaction 46.46 15.45 9 25754 230228 79488397
Rash 46.45 15.45 72 25691 578286 79140339
Tachycardia 45.03 15.45 143 25620 177625 79541000
Schizophrenia 44.17 15.45 38 25725 15402 79703223
Toxicity to various agents 43.78 15.45 43 25720 421497 79297128
Granuloma 42.75 15.45 29 25734 8268 79710357
Affective disorder 42.68 15.45 29 25734 8290 79710335
Lung diffusion test decreased 42.55 15.45 16 25747 1294 79717331
Seasonal allergy 42.17 15.45 38 25725 16368 79702257
Adjustment disorder 41.66 15.45 22 25741 3978 79714647
Choking 41.32 15.45 33 25730 12068 79706557
Bronchial hyperreactivity 41.26 15.45 20 25743 3020 79715605
Appetite disorder 39.76 15.45 27 25736 7712 79710913
Contraindicated product administered 39.45 15.45 3 25760 157535 79561090
Angle closure glaucoma 38.66 15.45 19 25744 2957 79715668
Rheumatoid arthritis 38.34 15.45 10 25753 208460 79510165
Treatment failure 38.13 15.45 5 25758 170481 79548144
Smoke sensitivity 37.39 15.45 12 25751 604 79718021
Depressive symptom 36.84 15.45 24 25739 6399 79712226
Hypoventilation 36.63 15.45 25 25738 7199 79711426
Diarrhoea 36.29 15.45 154 25609 880335 78838290
Laryngospasm 36.10 15.45 20 25743 3977 79714648
Nail dystrophy 35.20 15.45 13 25750 1000 79717625
Loss of personal independence in daily activities 35.14 15.45 92 25671 102488 79616137
Salivary hypersecretion 34.71 15.45 32 25731 14192 79704433
Rales 34.05 15.45 37 25726 19964 79698661
Arthralgia 32.41 15.45 87 25676 571716 79146909
Synovitis 32.35 15.45 5 25758 150729 79567896
Apnoea 31.85 15.45 28 25735 11676 79706949
Sinus tachycardia 30.80 15.45 48 25715 36860 79681765
Angioplasty 30.66 15.45 14 25749 1849 79716776
Body temperature abnormal 30.37 15.45 15 25748 2360 79716265
Arthropathy 29.82 15.45 10 25753 177101 79541524
Seizure 29.45 15.45 130 25633 188704 79529921
Umbilical hernia 29.10 15.45 20 25743 5825 79712800
Pulmonary oedema 29.06 15.45 78 25685 88176 79630449
Restless legs syndrome 28.81 15.45 34 25729 20058 79698567
Axillary pain 28.75 15.45 14 25749 2135 79716490
Pancytopenia 28.54 15.45 9 25754 165736 79552889
Depressed mood 28.53 15.45 54 25709 48426 79670199
Oxygen saturation decreased 28.37 15.45 99 25664 128948 79589677
Blood pressure systolic increased 28.16 15.45 65 25698 66921 79651704
Infective exacerbation of chronic obstructive airways disease 28.11 15.45 15 25748 2769 79715856
Nasal inflammation 27.75 15.45 10 25753 717 79717908
Serotonin syndrome 27.55 15.45 51 25712 44976 79673649
Influenza 27.27 15.45 98 25665 129508 79589117
Blood test abnormal 27.12 15.45 31 25732 17679 79700946
Pulmonary thrombosis 27.05 15.45 26 25737 12145 79706480
Bronchospasm paradoxical 26.99 15.45 7 25756 163 79718462
Eosinophilic granulomatosis with polyangiitis 26.87 15.45 16 25747 3644 79714981
Vulvovaginal candidiasis 26.68 15.45 14 25749 2500 79716125
Off label use 26.58 15.45 178 25585 907037 78811588
Ankle fracture 26.49 15.45 30 25733 16939 79701686
Therapeutic product effect decreased 26.31 15.45 10 25753 163853 79554772
Ischaemic cardiomyopathy 26.30 15.45 21 25742 7674 79710951
Dyslipidaemia 26.14 15.45 25 25738 11608 79707017
Dysphonia 25.93 15.45 57 25706 56815 79661810
Anaphylactic reaction 24.59 15.45 71 25692 83672 79634953
Nasopharyngitis 24.51 15.45 153 25610 253728 79464897
Abdominal discomfort 24.40 15.45 27 25736 250700 79467925
Bronchitis 24.33 15.45 95 25668 130549 79588076
Oedema peripheral 23.71 15.45 151 25612 252137 79466488
Pulmonary congestion 23.67 15.45 36 25727 27064 79691561
Pericarditis 23.44 15.45 3 25760 104233 79614392
Saliva altered 23.38 15.45 8 25755 492 79718133
Depression 23.06 15.45 134 25629 216656 79501969
Increased bronchial secretion 23.01 15.45 14 25749 3313 79715312
Dyspnoea at rest 23.00 15.45 19 25744 7283 79711342
Dyspnoea paroxysmal nocturnal 22.49 15.45 12 25751 2216 79716409
Occupational exposure to air contaminants 22.43 15.45 6 25757 158 79718467
Perfume sensitivity 22.39 15.45 9 25754 870 79717755
Drug hypersensitivity 22.27 15.45 39 25724 298877 79419748
Systemic lupus erythematosus 21.91 15.45 6 25757 121143 79597482
Upper respiratory tract infection 21.85 15.45 72 25691 91096 79627529
Intentional overdose 21.66 15.45 4 25759 105956 79612669
Swelling 21.45 15.45 23 25740 216688 79501937
Anaesthetic complication neurological 21.40 15.45 8 25755 636 79717989
Flank pain 21.19 15.45 29 25734 19815 79698810
Sinus operation 21.08 15.45 12 25751 2513 79716112
Choking sensation 20.96 15.45 14 25749 3892 79714733
White blood cell count decreased 20.95 15.45 18 25745 188270 79530355
Cholelithiasis 20.93 15.45 50 25713 52614 79666011
Staphylococcal scalded skin syndrome 20.86 15.45 7 25756 406 79718219
Intentional product misuse 20.78 15.45 3 25760 95162 79623463
Respiratory symptom 20.62 15.45 15 25748 4776 79713849
Cellulitis 20.49 15.45 5 25758 109055 79609570
Muscle disorder 20.42 15.45 16 25747 5691 79712934
Accelerated idioventricular rhythm 20.25 15.45 6 25757 231 79718394
Cardiorenal syndrome 20.21 15.45 10 25753 1579 79717046
Crepitations 19.67 15.45 20 25743 9997 79708628
Stress cardiomyopathy 19.61 15.45 21 25742 11145 79707480
Haemoglobin decreased 19.41 15.45 26 25737 222093 79496532
Respiratory rate increased 19.30 15.45 29 25734 21571 79697054
Neutropenia 19.28 15.45 40 25723 287670 79430955
Hypopnoea 19.20 15.45 15 25748 5314 79713311
Hypoxia 19.16 15.45 75 25688 103168 79615457
Cerebral thrombosis 19.01 15.45 11 25752 2376 79716249
Acute kidney injury 18.86 15.45 95 25668 519309 79199316
Drug abuse 18.78 15.45 15 25748 162676 79555949
Sputum purulent 18.69 15.45 9 25754 1340 79717285
Bradycardia 18.66 15.45 90 25673 135467 79583158
Blood bilirubin increased 18.34 15.45 55 25708 66177 79652448
Psychotic disorder 18.32 15.45 41 25722 41361 79677264
Upper airway obstruction 18.20 15.45 9 25754 1419 79717206
Platelet count decreased 17.82 15.45 22 25741 194642 79523983
Physical deconditioning 17.72 15.45 10 25753 2060 79716565
Peripheral vascular disorder 17.56 15.45 17 25746 8013 79710612
C-reactive protein increased 17.43 15.45 10 25753 129017 79589608
Aphonia 17.42 15.45 19 25744 10293 79708332
Brain injury 17.36 15.45 20 25743 11497 79707128
Opisthotonus 17.29 15.45 7 25756 689 79717936
Suicide attempt 17.24 15.45 3 25760 82929 79635696
Granulomatosis with polyangiitis 17.14 15.45 11 25752 2859 79715766
Muscle spasms 16.79 15.45 19 25744 174711 79543914
Dystonia 16.71 15.45 27 25736 21372 79697253
Staphylococcus test positive 16.63 15.45 15 25748 6466 79712159
Impaired healing 16.50 15.45 4 25759 87651 79630974
Respiratory acidosis 16.13 15.45 19 25744 11181 79707444
Pain in extremity 16.05 15.45 62 25701 364476 79354149
Heart rate increased 15.79 15.45 79 25684 120645 79597980
Catheter site haemorrhage 15.47 15.45 13 25750 5104 79713521

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A03AB02 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
Synthetic anticholinergics, quaternary ammonium compounds
ATC A03CA05 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
ANTISPASMODICS IN COMBINATION WITH PSYCHOLEPTICS
Synthetic anticholinergic agents in combination with psycholeptics
ATC D11AA01 DERMATOLOGICALS
OTHER DERMATOLOGICAL PREPARATIONS
OTHER DERMATOLOGICAL PREPARATIONS
Antihidrotics
ATC R03AL04 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03AL07 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03AL09 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03AL11 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03AL12 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03BB06 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Anticholinergics
FDA MoA N0000175370 Cholinergic Antagonists
FDA EPC N0000175574 Anticholinergic
CHEBI has role CHEBI:35523 bronchodilator
CHEBI has role CHEBI:48876 muscarinic antagonists
MeSH PA D000759 Adjuvants, Anesthesia
MeSH PA D002491 Central Nervous System Agents
MeSH PA D018678 Cholinergic Agents
MeSH PA D018680 Cholinergic Antagonists
MeSH PA D018727 Muscarinic Antagonists
MeSH PA D018377 Neurotransmitter Agents

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

DiseaseRelationSNOMED_IDDOID
Peptic ulcer indication 13200003 DOID:750
Chronic obstructive lung disease indication 13645005 DOID:3083
General anesthesia indication 50697003
Excessive salivation indication 53827007
Hyperhidrosis of axilla indication 303089000
Vagal Reflex Bradycardia indication
Irritable bowel syndrome off-label use 10743008 DOID:9778
Diarrhea off-label use 62315008
Brain damage contraindication 2470005
Tachyarrhythmia contraindication 6285003
Suicidal thoughts contraindication 6471006
Urinary tract obstruction contraindication 7163005 DOID:5200
Alcoholism contraindication 7200002
Hyperammonemia contraindication 9360008
Hepatic encephalopathy contraindication 13920009 DOID:13413
Severe chronic ulcerative colitis contraindication 14311001
Toxic megacolon contraindication 28536002 DOID:1770
Atony of colon contraindication 29479008
Hyperthyroidism contraindication 34486009 DOID:7998
Depressive disorder contraindication 35489007
Hypertensive disorder contraindication 38341003 DOID:10763
Complete trisomy 21 syndrome contraindication 41040004 DOID:14250
Achalasia of esophagus contraindication 45564002 DOID:9164
Chronic heart failure contraindication 48447003
Paralytic ileus contraindication 55525008 DOID:8442
Peptic reflux disease contraindication 57643001
Hepatic failure contraindication 59927004
Ulcerative colitis contraindication 64766004 DOID:8577
Poisoning by phenobarbital contraindication 64921004
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Hepatic coma contraindication 72836002 DOID:12550
Sleep apnea contraindication 73430006 DOID:0050847
Spastic paralysis contraindication 78403003
Disturbance of salivary secretion contraindication 78948009
Hiatal hernia contraindication 84089009 DOID:12642
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Gastrointestinal obstruction contraindication 126765001
Autonomic dysreflexia contraindication 129618003
Bleeding contraindication 131148009
Myocardial dysfunction contraindication 233928007
Disease of liver contraindication 235856003 DOID:409
Bladder outflow obstruction contraindication 236645006
Pyloric obstruction contraindication 244815007
Benign prostatic hyperplasia contraindication 266569009
Dyspnea contraindication 267036007
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Drowsy contraindication 271782001
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Angle-closure glaucoma contraindication 392291006 DOID:13550
Gastric ulcer contraindication 397825006 DOID:10808
Breastfeeding (mother) contraindication 413712001
Chronic lung disease contraindication 413839001
Disorder of coronary artery contraindication 414024009
Porphyria contraindication 418470004




🐶 Veterinary Drug Use

SpeciesUseRelation
Cats Preanesthesia Indication
Dogs Preanesthesia Indication

🐶 Veterinary products

ProductApplicantIngredients
Robinul-V Injectable Zoetis Inc. 1
Glycopyrrolate Injectable, Robinul-V Cronus Pharma Specialities India Private Limited 1

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1MG/5ML CUVPOSA MERZ PHARMS N022571 July 28, 2010 RX SOLUTION ORAL 7638552 Aug. 20, 2023 REDUCE CHRONIC SEVERE DROOLING (I.E., SIALORRHEA) IN PATIENTS WITH NEUROLOGIC CONDITIONS ASSOCIATED WITH PROBLEM DROOLING
1MG/5ML CUVPOSA MERZ PHARMS N022571 July 28, 2010 RX SOLUTION ORAL 7816396 Aug. 20, 2023 REDUCE CHRONIC SEVERE DROOLING (I.E., SIALORRHEA) IN PATIENTS WITH NEUROLOGIC CONDITIONS ASSOCIATED WITH PROBLEM DROOLING
15.6MCG/INH;27.5MCG/INH UTIBRON NOVARTIS N207930 Oct. 29, 2015 DISCN POWDER INHALATION 6878721 Feb. 25, 2025 LONG-TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
25MCG/ML LONHALA MAGNAIR KIT SUMITOMO PHARMA AM N208437 Dec. 5, 2017 DISCN SOLUTION INHALATION 10940110 Feb. 26, 2029 LONG-TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 10716753 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 8324266 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 8703806 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 8808713 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 9463161 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 10716753 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 8324266 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 8703806 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 8808713 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 9463161 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 8815258 March 17, 2031 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 8815258 March 17, 2031 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
25MCG/ML LONHALA MAGNAIR KIT SUMITOMO PHARMA AM N208437 Dec. 5, 2017 DISCN SOLUTION INHALATION 10744277 Dec. 7, 2036 A METHOD OF USING AN AEROSOL DELIVERY DEVICE TO AEROSOLIZE GLYCOPYRROLATE FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION July 23, 2023 NEW COMBINATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Muscarinic acetylcholine receptor M1 GPCR ANTAGONIST Ki 9.69 SCIENTIFIC LITERATURE CHEMBL
Muscarinic acetylcholine receptor M2 GPCR ANTAGONIST Ki 9.25 SCIENTIFIC LITERATURE IUPHAR
Muscarinic acetylcholine receptor M3 GPCR ANTAGONIST Ki 9.64 SCIENTIFIC LITERATURE CHEMBL
Muscarinic acetylcholine receptor M4 GPCR ANTAGONIST Ki 9.06 SCIENTIFIC LITERATURE IUPHAR
Muscarinic acetylcholine receptor M5 GPCR ANTAGONIST Ki 8.91 SCIENTIFIC LITERATURE IUPHAR

External reference:

IDSource
4018421 VUID
N0000146747 NUI
D00540 KEGG_DRUG
51186-83-5 SECONDARY_CAS_RN
740028-90-4 SECONDARY_CAS_RN
4018421 VANDF
4038210 VANDF
C4082411 UMLSCUI
CHEBI:90972 CHEBI
CHEMBL1201027 ChEMBL_ID
11693 PUBCHEM_CID
7459 IUPHAR_LIGAND_ID
DB00986 DRUGBANK_ID
1546438 RXNORM
4794 MMSL
609 MMSL
d00992 MMSL
001737 NDDF
017641 NDDF
387122008 SNOMEDCT_US
769097000 SNOMEDCT_US
772943003 SNOMEDCT_US
D006024 MESH_DESCRIPTOR_UI
CHEMBL1201335 ChEMBL_ID
CHEMBL3707243 ChEMBL_ID
1038 INN_ID
V92SO9WP2I UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-1250 TABLET 1 mg ORAL ANDA 12 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-1251 TABLET 2 mg ORAL ANDA 12 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9584 INJECTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9584 INJECTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9585 INJECTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9585 INJECTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9586 INJECTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9586 INJECTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9587 INJECTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9587 INJECTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9679 INJECTION 0.20 mg INTRAMUSCULAR ANDA 24 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9679 INJECTION 0.20 mg INTRAMUSCULAR ANDA 24 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9680 INJECTION 0.20 mg INTRAMUSCULAR ANDA 24 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9680 INJECTION 0.20 mg INTRAMUSCULAR ANDA 24 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9681 INJECTION 0.20 mg INTRAMUSCULAR ANDA 24 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9681 INJECTION 0.20 mg INTRAMUSCULAR ANDA 24 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9682 INJECTION 0.20 mg INTRAMUSCULAR ANDA 24 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9682 INJECTION 0.20 mg INTRAMUSCULAR ANDA 24 sections
Cuvposa HUMAN PRESCRIPTION DRUG LABEL 1 0259-0501 LIQUID 1 mg ORAL NDA 27 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0259-0502 LIQUID 1 mg ORAL NDA AUTHORIZED GENERIC 30 sections
BEVESPI AEROSPHERE HUMAN PRESCRIPTION DRUG LABEL 2 0310-4600 AEROSOL, METERED 9 ug RESPIRATORY (INHALATION) NDA 29 sections
BEVESPI AEROSPHERE HUMAN PRESCRIPTION DRUG LABEL 2 0310-4600 AEROSOL, METERED 9 ug RESPIRATORY (INHALATION) NDA 29 sections
BEVESPI AEROSPHERE HUMAN PRESCRIPTION DRUG LABEL 2 0310-4600 AEROSOL, METERED 9 ug RESPIRATORY (INHALATION) NDA 29 sections
BREZTRI HUMAN PRESCRIPTION DRUG LABEL 3 0310-4616 AEROSOL, METERED 9 ug RESPIRATORY (INHALATION) NDA 28 sections
BREZTRI HUMAN PRESCRIPTION DRUG LABEL 3 0310-4616 AEROSOL, METERED 9 ug RESPIRATORY (INHALATION) NDA 28 sections
GLYCOPYRROLATE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9867 INJECTION 0.20 mg INTRAMUSCULAR ANDA 12 sections
GLYCOPYRROLATE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9867 INJECTION 0.20 mg INTRAMUSCULAR ANDA 12 sections
GLYCOPYRROLATE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9868 INJECTION 0.20 mg INTRAMUSCULAR ANDA 12 sections
GLYCOPYRROLATE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9868 INJECTION 0.20 mg INTRAMUSCULAR ANDA 12 sections
GLYCOPYRROLATE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9869 INJECTION 0.20 mg INTRAMUSCULAR ANDA 12 sections