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

Stem definition	Drug id	CAS RN
	4302	596-51-0

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
3	mg	O
0.30	mg	P
3	mg	R
44	mcg	Inhal.powder

ADMET properties:

Property	Value	Reference
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:

Date	Agency	Company	Orphan
Aug. 11, 1961	FDA	SHIONOGI INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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)

Disease	Relation	SNOMED_ID	DOID
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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN	ANTAGONIST	Ki	9.69	SCIENTIFIC LITERATURE	CHEMBL
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN	ANTAGONIST	Ki	9.25	SCIENTIFIC LITERATURE	IUPHAR
Muscarinic acetylcholine receptor M3	GPCR	P20309	ACM3_HUMAN	ANTAGONIST	Ki	9.64	SCIENTIFIC LITERATURE	CHEMBL
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN	ANTAGONIST	Ki	9.06	SCIENTIFIC LITERATURE	IUPHAR
Muscarinic acetylcholine receptor M5	GPCR	P08912	ACM5_HUMAN	ANTAGONIST	Ki	8.91	SCIENTIFIC LITERATURE	IUPHAR

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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