glycopyrronium bromide 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
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

Approvals:

DateAgencyCompanyOrphan
Aug. 11, 1961 FDA SHIONOGI INC

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 425.27 14.75 297 14500 91245 46580020
Dyspnoea 231.09 14.75 504 14293 515044 46156221
Wheezing 203.66 14.75 154 14643 53232 46618033
Obstructive airways disorder 201.56 14.75 94 14703 13318 46657947
Chronic obstructive pulmonary disease 197.50 14.75 156 14641 57477 46613788
Cough 197.40 14.75 299 14498 229950 46441315
Forced expiratory volume decreased 187.99 14.75 68 14729 5036 46666229
Total lung capacity increased 164.06 14.75 40 14757 734 46670531
Sputum discoloured 125.19 14.75 67 14730 12711 46658554
Productive cough 99.11 14.75 100 14697 50615 46620650
Sleep apnoea syndrome 77.88 14.75 61 14736 22140 46649125
Respiration abnormal 75.14 14.75 34 14763 4487 46666778
Glaucoma 74.42 14.75 52 14745 15869 46655396
Blood pressure systolic increased 64.11 14.75 61 14736 28726 46642539
Lower respiratory tract infection 64.00 14.75 83 14714 55006 46616259
Breast cancer recurrent 63.69 14.75 29 14768 3882 46667383
Asthma-chronic obstructive pulmonary disease overlap syndrome 63.02 14.75 17 14780 472 46670793
Forced vital capacity decreased 56.76 14.75 18 14779 889 46670376
Lung neoplasm malignant 53.11 14.75 42 14755 15447 46655818
Frustration tolerance decreased 52.70 14.75 28 14769 5229 46666036
Rheumatoid arthritis 52.59 14.75 7 14790 240208 46431057
Nasal congestion 52.03 14.75 70 14727 48043 46623222
Pneumonia 51.17 14.75 245 14552 376075 46295190
Hyper IgE syndrome 49.69 14.75 12 14785 211 46671054
Secretion discharge 47.54 14.75 32 14765 9187 46662078
Product use in unapproved indication 45.38 14.75 93 14704 90180 46581085
Bronchial neoplasm 43.39 14.75 11 14786 238 46671027
Humidity intolerance 43.22 14.75 12 14785 372 46670893
Peak expiratory flow rate decreased 41.39 14.75 13 14784 622 46670643
Nasal polyps 41.15 14.75 18 14779 2192 46669073
Lung diffusion test decreased 41.13 14.75 13 14784 635 46670630
Restrictive pulmonary disease 40.20 14.75 15 14782 1211 46670054
Bronchial haemorrhage 39.84 14.75 11 14786 334 46670931
Blood immunoglobulin E increased 38.15 14.75 16 14781 1757 46669508
Nasal turbinate hypertrophy 37.47 14.75 11 14786 418 46670847
Dyspnoea exertional 36.88 14.75 61 14736 50228 46621037
Respiratory failure 36.71 14.75 88 14709 94728 46576537
Pulmonary thrombosis 36.52 14.75 25 14772 7377 46663888
Bronchial disorder 35.17 14.75 13 14784 1022 46670243
Pulmonary function test decreased 34.53 14.75 19 14778 3801 46667464
Endometrial ablation 32.17 14.75 11 14786 689 46670576
Tachycardia 31.85 14.75 86 14711 99536 46571729
Choking 31.51 14.75 24 14773 8352 46662913
Drug hypersensitivity 30.36 14.75 20 14777 243805 46427460
Infective exacerbation of chronic obstructive airways disease 30 14.75 12 14785 1168 46670097
Chest discomfort 29.94 14.75 79 14718 90190 46581075
Pain 29.89 14.75 67 14730 476881 46194384
Oxygen saturation decreased 29.85 14.75 67 14730 69097 46602168
Alopecia 28.65 14.75 8 14789 162406 46508859
Nasal inflammation 28.41 14.75 9 14788 443 46670822
Staphylococcal scalded skin syndrome 27.63 14.75 7 14790 151 46671114
Staphylococcus test positive 27.47 14.75 16 14781 3568 46667697
Asthmatic crisis 27.39 14.75 12 14785 1466 46669799
Bronchiectasis 27.18 14.75 23 14774 9293 46661972
Urinary retention 26.77 14.75 37 14760 26024 46645241
Arthralgia 26.44 14.75 47 14750 364556 46306709
Brain injury 26.22 14.75 19 14778 6131 46665134
Perfume sensitivity 26.15 14.75 9 14788 575 46670690
Blood count abnormal 25.69 14.75 30 14767 17848 46653417
Sleep disorder due to a general medical condition 25.18 14.75 15 14782 3484 46667781
Atrioventricular dissociation 25.18 14.75 7 14790 218 46671047
Stress cardiomyopathy 24.33 14.75 20 14777 7764 46663501
Rhinitis allergic 24.25 14.75 19 14778 6889 46664376
Anaphylactic reaction 23.52 14.75 52 14745 53060 46618205
Increased bronchial secretion 23.27 14.75 11 14786 1603 46669662
Hypoventilation 22.96 14.75 15 14782 4095 46667170
Middle insomnia 22.78 14.75 21 14776 9494 46661771
Rhonchi 22.77 14.75 12 14785 2203 46669062
Depression 22.46 14.75 110 14687 169994 46501271
Sarcoidosis 22.14 14.75 16 14781 5143 46666122
Rhinitis 22.01 14.75 19 14778 7887 46663378
Polycystic ovaries 21.71 14.75 10 14787 1374 46669891
Nasopharyngitis 21.35 14.75 101 14696 153897 46517368
Sneezing 21.06 14.75 23 14774 12718 46658547
Pulmonary oedema 20.38 14.75 48 14749 51057 46620208
Body temperature abnormal 20.17 14.75 9 14788 1149 46670116
Acute pulmonary oedema 20.04 14.75 18 14779 7873 46663392
Rash 19.99 14.75 53 14744 356459 46314806
Pulmonary congestion 19.88 14.75 24 14773 14775 46656490
Infusion related reaction 19.78 14.75 4 14793 101204 46570061
Upper airway obstruction 19.15 14.75 7 14790 533 46670732
Apnoea 19.15 14.75 17 14780 7322 46663943
Paranoia 19.05 14.75 20 14777 10577 46660688
Diarrhoea 18.58 14.75 103 14694 559499 46111766
Nausea 18.50 14.75 135 14662 687319 45983946
Breath sounds abnormal 18.23 14.75 17 14780 7798 46663467
Dystonia 18.05 14.75 20 14777 11237 46660028
Abdominal discomfort 18.00 14.75 13 14784 151152 46520113
Respiratory acidosis 17.57 14.75 15 14782 6133 46665132
Treatment failure 17.53 14.75 4 14793 93083 46578182
Influenza 17.40 14.75 65 14732 89205 46582060
Respiratory distress 17.35 14.75 34 14763 31882 46639383
Laryngospasm 17.32 14.75 11 14786 2862 46668403
Tachypnoea 17.24 14.75 22 14775 14329 46656936
Rales 17.00 14.75 18 14779 9613 46661652
Mite allergy 16.97 14.75 6 14791 415 46670850
Arthritis 16.51 14.75 58 14739 77258 46594007
Joint swelling 16.47 14.75 17 14780 166056 46505209
Congestive cardiomyopathy 16.45 14.75 14 14783 5699 46665566
Rhinorrhoea 16.08 14.75 42 14755 47623 46623642
Eosinophilic pneumonia chronic 15.98 14.75 4 14793 82 46671183
Throat irritation 15.97 14.75 31 14766 28870 46642395
Respiratory disorder 15.97 14.75 30 14767 27270 46643995
Heart sounds 15.75 14.75 5 14792 248 46671017
Seasonal allergy 15.32 14.75 20 14777 13314 46657951
Irregular breathing 15.32 14.75 5 14792 271 46670994
Upper respiratory tract inflammation 15.13 14.75 10 14787 2785 46668480
Mucosal infection 14.97 14.75 4 14793 107 46671158

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
Chronic obstructive pulmonary disease 293.99 14.23 201 12103 45925 29894249
Dyspnoea 213.20 14.23 439 11865 332856 29607318
Asthma 167.36 14.23 130 12174 36044 29904130
Cough 141.62 14.23 213 12091 125429 29814745
Wheezing 103.08 14.23 92 12212 30846 29909328
Productive cough 95.70 14.23 87 12217 29866 29910308
Forced expiratory volume decreased 74.23 14.23 33 12271 3217 29936957
Blood immunoglobulin E increased 54.25 14.23 22 12282 1708 29938466
Chest discomfort 53.74 14.23 79 12225 45401 29894773
Lymph node calcification 52.42 14.23 13 12291 195 29939979
Emphysema 50.52 14.23 37 12267 9365 29930809
Dyspnoea exertional 48.44 14.23 66 12238 35364 29904810
Tachycardia 47.54 14.23 98 12206 73641 29866533
Serotonin syndrome 43.95 14.23 45 12259 17846 29922328
Dyspnoea at rest 42.59 14.23 21 12283 2585 29937589
Bronchial disorder 40.70 14.23 15 12289 899 29939275
Bronchospasm 34.90 14.23 31 12273 10307 29929867
General physical health deterioration 34.82 14.23 105 12199 99839 29840335
Obstructive airways disorder 34.29 14.23 29 12275 9030 29931144
Haemoptysis 31.08 14.23 50 12254 31028 29909146
Secretion discharge 30.17 14.23 19 12285 3756 29936418
Bronchial obstruction 27.46 14.23 13 12291 1463 29938711
Toxicity to various agents 27.06 14.23 20 12284 177163 29763011
Physical deconditioning 26.71 14.23 10 12294 626 29939548
Lung neoplasm malignant 26.68 14.23 32 12272 15100 29925074
Saliva altered 25.24 14.23 7 12297 165 29940009
Cardiorenal syndrome 24.88 14.23 10 12294 758 29939416
Rhinitis perennial 23.01 14.23 6 12298 111 29940063
Lung disorder 22.86 14.23 44 12260 31425 29908749
Pneumonia 22.74 14.23 223 12081 334083 29606091
Product use issue 21.64 14.23 54 12250 45962 29894212
Forced vital capacity decreased 21.43 14.23 9 12295 763 29939411
Respiratory tract infection 21.35 14.23 29 12275 15477 29924697
Pseudomonal sepsis 21.26 14.23 14 12290 2986 29937188
Choking 21.15 14.23 17 12287 4929 29935245
Sputum discoloured 20.55 14.23 19 12285 6649 29933525
Smoke sensitivity 20.45 14.23 6 12298 174 29940000
Grunting 20.32 14.23 7 12297 344 29939830
Appendicitis perforated 19.68 14.23 11 12293 1747 29938427
Drug intolerance 19.08 14.23 51 12253 45240 29894934
Arrhythmia 18.94 14.23 42 12262 33127 29907047
Pneumothorax 18.92 14.23 28 12276 16165 29924009
Haemoglobin decreased 18.57 14.23 12 12292 114086 29826088
Sputum purulent 18.57 14.23 7 12297 447 29939727
Micturition urgency 18.54 14.23 15 12289 4392 29935782
Sleep disorder due to a general medical condition 18.44 14.23 10 12294 1497 29938677
Drug abuse 17.39 14.23 6 12298 82066 29858108
Anaesthetic complication neurological 16.79 14.23 6 12298 329 29939845
Pulmonary function test decreased 16.77 14.23 14 12290 4281 29935893
Feeling cold 16.77 14.23 20 12284 9379 29930795
Nasal polyps 16.46 14.23 9 12295 1370 29938804
Angina pectoris 16.43 14.23 37 12267 29481 29910693
Pulmonary function test abnormal 16.36 14.23 9 12295 1387 29938787
Respiratory rate increased 15.95 14.23 19 12285 8896 29931278
Urinary retention 15.86 14.23 39 12265 32878 29907296
Buttock injury 15.83 14.23 4 12300 65 29940109
Sitting disability 15.71 14.23 4 12300 67 29940107
Prolonged expiration 15.41 14.23 5 12299 204 29939970
Cataract 15.21 14.23 30 12274 21805 29918369
Pancytopenia 15.17 14.23 8 12296 85044 29855130
Chronic respiratory failure 14.68 14.23 8 12296 1210 29938964
Respiratory disorder 14.64 14.23 26 12278 17468 29922706
Xanthelasma 14.32 14.23 4 12300 97 29940077

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 D11AA01 DERMATOLOGICALS
OTHER DERMATOLOGICAL PREPARATIONS
OTHER DERMATOLOGICAL PREPARATIONS
Antihidrotics
ATC R03BB06 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Anticholinergics
ATC A03CA05 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
ANTISPASMODICS IN COMBINATION WITH PSYCHOLEPTICS
Synthetic anticholinergic agents in combination with psycholeptics
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
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
FDA MoA N0000175370 Cholinergic Antagonists
FDA EPC N0000175574 Anticholinergic
CHEBI has role CHEBI:35523 bronchodilator agents
CHEBI has role CHEBI:48876 antimuskarinika

Drug Use (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
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

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

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 COMBINULLTION

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
4018421 VANDF
4038210 VANDF
C0017970 UMLSCUI
CHEBI:94449 CHEBI
CHEMBL1201027 ChEMBL_ID
CHEMBL1201335 ChEMBL_ID
DB00986 DRUGBANK_ID
D006024 MESH_DESCRIPTOR_UI
11693 PUBCHEM_CID
7459 IUPHAR_LIGAND_ID
1038 INN_ID
V92SO9WP2I UNII
1546438 RXNORM
4794 MMSL
609 MMSL
d00992 MMSL
001737 NDDF
017641 NDDF
387122008 SNOMEDCT_US
769097000 SNOMEDCT_US
772943003 SNOMEDCT_US

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 0143-9585 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 0143-9587 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 0143-9680 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 0143-9682 INJECTION 0.20 mg INTRAMUSCULAR ANDA 24 sections
Cuvposa HUMAN PRESCRIPTION DRUG LABEL 1 0259-0501 LIQUID 1 mg ORAL NDA 27 sections
BEVESPI AEROSPHERE HUMAN PRESCRIPTION DRUG LABEL 2 0310-4600 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 0517-4601 INJECTION, SOLUTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0517-4602 INJECTION, SOLUTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0517-4605 INJECTION, SOLUTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0517-4620 INJECTION, SOLUTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8170 TABLET 1 mg ORAL ANDA 15 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6033 INJECTION 0.20 mg INTRAMUSCULAR NDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6034 INJECTION 0.20 mg INTRAMUSCULAR NDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6035 INJECTION 0.20 mg INTRAMUSCULAR NDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6036 INJECTION 0.20 mg INTRAMUSCULAR NDA 23 sections
Robinul HUMAN PRESCRIPTION DRUG LABEL 1 0641-6104 INJECTION 0.20 mg INTRAMUSCULAR NDA 23 sections
Robinul HUMAN PRESCRIPTION DRUG LABEL 1 0641-6105 INJECTION 0.20 mg INTRAMUSCULAR NDA 23 sections
Robinul HUMAN PRESCRIPTION DRUG LABEL 1 0641-6106 INJECTION 0.20 mg INTRAMUSCULAR NDA 23 sections
Robinul HUMAN PRESCRIPTION DRUG LABEL 1 0641-6107 INJECTION 0.20 mg INTRAMUSCULAR NDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0722-7097 TABLET 1.50 mg ORAL ANDA 16 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0781-3825 INJECTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0781-3827 INJECTION 0.40 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0781-3829 INJECTION 1 mg INTRAMUSCULAR ANDA 23 sections