atropine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
atropine derivatives 260 51-55-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • atropine
  • (+/-)-Atropine
  • atropin
  • atropinum sulphuricum
  • DL-Hyoscyamine
  • tropine tropate
  • atropine sulfate
An alkaloid, originally from Atropa belladonna, but found in other plants, mainly SOLANACEAE. Hyoscyamine is the 3(S)-endo isomer of atropine.
  • Molecular weight: 289.38
  • Formula: C17H23NO3
  • CLOGP: 1.30
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 49.77
  • ALOGS: -2.06
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1.50 mg O
1.50 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 57 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.03 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 3.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 7.60 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.61 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 4.10 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Sept. 15, 1960 FDA GD SEARLE LLC

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
Diarrhoea 294.33 11.10 860 26907 558742 46099553
Dehydration 106.74 11.10 269 27498 159271 46499024
Stress cardiomyopathy 85.79 11.10 55 27712 7729 46650566
Bradycardia 63.47 11.10 129 27638 66169 46592126
Rheumatoid arthritis 53.43 11.10 39 27728 240176 46418119
Blood magnesium increased 53.41 11.10 29 27738 2998 46655297
Pleural thickening 51.83 11.10 27 27740 2568 46655727
Presbyacusis 46.94 11.10 26 27741 2796 46655499
Abdominal pain 46.64 11.10 264 27503 229767 46428528
Pleural fibrosis 43.80 11.10 27 27740 3542 46654753
Deafness neurosensory 40.46 11.10 28 27739 4466 46653829
Bone cyst 39.99 11.10 21 27746 2030 46656265
Vomiting 35.48 11.10 418 27349 452376 46205919
Osteosclerosis 34.25 11.10 23 27744 3493 46654802
Small intestinal obstruction 32.54 11.10 44 27723 16128 46642167
Epigastric discomfort 32.49 11.10 27 27740 5657 46652638
Completed suicide 30.74 11.10 25 27742 145895 46512400
Drug monitoring procedure not performed 27.60 11.10 10 27757 391 46657904
Cyst 27.57 11.10 35 27732 12065 46646230
Hypotension 27.50 11.10 234 27533 232355 46425940
Intestinal obstruction 26.45 11.10 52 27715 26023 46632272
Enzyme induction 24.79 11.10 6 27761 54 46658241
Bulimia nervosa 24.62 11.10 10 27757 535 46657760
Polydipsia 23.96 11.10 18 27749 3261 46655034
Anorectal disorder 23.53 11.10 13 27754 1391 46656904
Short-bowel syndrome 23.51 11.10 9 27758 411 46657884
Macular degeneration 23.39 11.10 25 27742 7180 46651115
Drug abuse 22.63 11.10 5 27762 63403 46594892
Ventricular asystole 22.37 11.10 6 27761 84 46658211
Gastroenteritis radiation 21.68 11.10 9 27758 509 46657786
Hyperthermia malignant 21.56 11.10 10 27757 739 46657556
Death 21.22 11.10 298 27469 335250 46323045
Anticholinergic syndrome 20.49 11.10 13 27754 1793 46656502
Cardiac arrest 20.45 11.10 107 27660 90292 46568003
Joint swelling 20.07 11.10 43 27724 166030 46492265
Purpura senile 19.92 11.10 9 27758 626 46657669
Blood potassium increased 19.89 11.10 36 27731 16931 46641364
Weight decreased 19.33 11.10 201 27566 210648 46447647
Cardiac assistance device user 19.28 11.10 5 27762 61 46658234
Skin lesion 18.81 11.10 46 27721 26667 46631628
Mydriasis 18.68 11.10 27 27740 10526 46647769
Osteopenia 18.64 11.10 35 27732 16926 46641369
Needle issue 18.59 11.10 20 27747 5784 46652511
Lower respiratory tract infection 18.38 11.10 5 27762 55084 46603211
Respiratory depression 18.13 11.10 28 27739 11572 46646723
Neuromuscular block prolonged 17.96 11.10 8 27759 538 46657757
Clostridium difficile colitis 17.62 11.10 36 27731 18517 46639778
Agitation postoperative 17.41 11.10 4 27763 28 46658267
Ventricular tachycardia 17.40 11.10 34 27733 16933 46641362
Ventricular fibrillation 16.93 11.10 27 27740 11469 46646826
Disease progression 16.65 11.10 102 27665 91198 46567097
Tarsal tunnel syndrome 16.57 11.10 8 27759 647 46657648
Deformity 16.55 11.10 21 27746 7236 46651059
Abortion spontaneous 16.50 11.10 3 27764 43643 46614652
Blood potassium decreased 16.48 11.10 55 27712 38008 46620287
Exostosis 16.36 11.10 25 27742 10238 46648057
Synovitis 16.24 11.10 8 27759 61067 46597228
N-terminal prohormone brain natriuretic peptide 16.14 11.10 4 27763 40 46658255
Atrioventricular block complete 15.72 11.10 21 27746 7606 46650689
Hypovolaemia 15.64 11.10 24 27743 9864 46648431
Decreased appetite 15.56 11.10 180 27587 193656 46464639
Endophthalmitis 15.55 11.10 14 27753 3264 46655031
Haemodynamic instability 15.51 11.10 21 27746 7704 46650591
Contraindicated product administered 15.26 11.10 15 27752 79932 46578363
Systemic lupus erythematosus 15.23 11.10 10 27757 65170 46593125
Dysarthria 15.20 11.10 53 27714 37445 46620850
Dry eye 15.12 11.10 46 27721 30276 46628019
Frequent bowel movements 15.06 11.10 27 27740 12605 46645690
Ileostomy 14.94 11.10 9 27758 1133 46657162
Spleen congestion 14.93 11.10 5 27762 154 46658141
Nausea 14.86 11.10 523 27244 686931 45971364
Neuromuscular blockade 14.82 11.10 6 27761 318 46657977
Pulmonary oedema 14.82 11.10 65 27702 51040 46607255
Disseminated intravascular coagulation 14.76 11.10 34 27733 18971 46639324
Psoriasis 14.72 11.10 15 27752 78589 46579706
Anterior spinal artery syndrome 14.66 11.10 4 27763 60 46658235
Arthralgia 13.99 11.10 144 27623 364459 46293836
Neuropathy peripheral 13.80 11.10 97 27670 90796 46567499
Systolic dysfunction 13.78 11.10 9 27758 1305 46656990
pH body fluid abnormal 13.77 11.10 4 27763 76 46658219
Sinus arrest 13.77 11.10 10 27757 1721 46656574
C-reactive protein increased 13.68 11.10 9 27758 58581 46599714
Apparent life threatening event 13.27 11.10 4 27763 87 46658208
Gastrointestinal disorder 13.11 11.10 70 27697 59506 46598789
Blood pressure systolic decreased 13.10 11.10 16 27751 5302 46652993
Cerebral congestion 12.94 11.10 3 27764 22 46658273
Intraductal papilloma of breast 12.70 11.10 4 27763 101 46658194
BRASH syndrome 12.66 11.10 4 27763 102 46658193
Arteriospasm coronary 12.53 11.10 13 27754 3608 46654687
Resorption bone increased 12.51 11.10 8 27759 1119 46657176
Anterior chamber flare 12.45 11.10 4 27763 108 46658187
Cardiogenic shock 12.38 11.10 29 27738 16355 46641940
Corneal perforation 12.26 11.10 6 27761 500 46657795
Fistula 12.05 11.10 19 27748 7991 46650304
Maternal exposure during pregnancy 12.01 11.10 27 27740 102522 46555773
Malnutrition 11.93 11.10 26 27741 13977 46644318
Asthenia 11.92 11.10 255 27512 310820 46347475
Apnoea 11.87 11.10 18 27749 7321 46650974
Failure to thrive 11.72 11.10 17 27750 6647 46651648
Crohn's disease 11.51 11.10 17 27750 6754 46651541
Swelling 11.41 11.10 37 27730 124474 46533821
Opsoclonus myoclonus 11.28 11.10 4 27763 147 46658148
Colitis 11.21 11.10 48 27719 37299 46620996
Anaesthetic complication 11.16 11.10 9 27758 1808 46656487
Panophthalmitis 11.12 11.10 3 27764 43 46658252
Vestibular disorder 11.11 11.10 8 27759 1358 46656937

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
Diarrhoea 242.37 11.95 636 20113 333467 29598262
Dehydration 82.48 11.95 229 20520 123310 29808419
Anticholinergic syndrome 62.60 11.95 23 20726 801 29930928
Hyperthermia malignant 56.81 11.95 27 20722 1807 29929922
Nausea 36.48 11.95 339 20410 296618 29635111
Bradycardia 35.57 11.95 113 20636 65413 29866316
Fatigue 34.48 11.95 356 20393 320317 29611412
Alopecia 32.09 11.95 52 20697 19223 29912506
Emotional disorder 31.48 11.95 27 20722 5067 29926662
Change of bowel habit 28.56 11.95 14 20735 1003 29930726
Vomiting 26.95 11.95 251 20498 219567 29712162
Stoma site pain 26.70 11.95 12 20737 706 29931023
Mouth ulceration 25.45 11.95 34 20715 10575 29921154
Cardiac arrest 25.20 11.95 129 20620 92721 29839008
Anterior chamber disorder 23.73 11.95 7 20742 120 29931609
Colitis 23.38 11.95 60 20689 30760 29900969
Arteriospasm coronary 22.86 11.95 17 20732 2601 29929128
Corneal oedema 22.50 11.95 13 20736 1299 29930430
Decreased appetite 22.44 11.95 179 20570 149731 29781998
Disease progression 22.39 11.95 112 20637 79762 29851967
Interstitial lung disease 22.24 11.95 7 20742 60190 29871539
Anaesthetic complication 22.17 11.95 12 20737 1057 29930672
Drug abuse 21.91 11.95 15 20734 82057 29849672
Oral pain 20.68 11.95 29 20720 9440 29922289
Cholinergic syndrome 20.67 11.95 9 20740 491 29931238
Stress cardiomyopathy 20.50 11.95 13 20736 1536 29930193
Pulse absent 20.48 11.95 22 20727 5451 29926278
Ventricular fibrillation 20.15 11.95 37 20712 15101 29916628
Small intestinal obstruction 18.97 11.95 34 20715 13625 29918104
Pupil fixed 18.52 11.95 13 20736 1819 29929910
Mydriasis 18.41 11.95 22 20727 6121 29925608
Rebound psychosis 18.40 11.95 6 20743 145 29931584
Tachycardia 18.31 11.95 100 20649 73639 29858090
Vasoplegia syndrome 17.66 11.95 11 20738 1260 29930469
Drug interaction 17.48 11.95 75 20674 199493 29732236
Keratitis fungal 17.21 11.95 5 20744 81 29931648
Laryngospasm 17.10 11.95 11 20738 1332 29930397
Rheumatoid arthritis 16.69 11.95 4 20745 41193 29890536
Limb mass 16.66 11.95 8 20741 548 29931181
Choroidal detachment 16.45 11.95 7 20742 361 29931368
Dermatitis acneiform 16.43 11.95 20 20729 5669 29926060
Keratic precipitates 16.42 11.95 5 20744 96 29931633
Oesophageal mucosa erythema 16.34 11.95 4 20745 32 29931697
Hypocapnia 16.18 11.95 5 20744 101 29931628
Proteinuria 16.13 11.95 35 20714 16110 29915619
Hypertension 16.06 11.95 141 20608 121213 29810516
Blood creatinine decreased 15.93 11.95 14 20735 2713 29929016
Agitation postoperative 15.63 11.95 4 20745 39 29931690
Atrioventricular block 15.45 11.95 22 20727 7260 29924469
Acute kidney injury 15.33 11.95 119 20630 273723 29658006
Anal stenosis 15.29 11.95 5 20744 122 29931607
Scleritis 14.89 11.95 6 20743 269 29931460
Sinus tachycardia 14.80 11.95 33 20716 15471 29916258
Abdominal pain 14.67 11.95 151 20598 135503 29796226
Respiration abnormal 14.32 11.95 13 20736 2629 29929100
Visual acuity tests abnormal 14.31 11.95 4 20745 56 29931673
Flat anterior chamber of eye 13.76 11.95 4 20745 65 29931664
Muscle twitching 13.57 11.95 22 20727 8133 29923596
Mucosal atrophy 13.48 11.95 4 20745 70 29931659
Pigment dispersion syndrome 13.46 11.95 3 20746 15 29931714
Clostridium difficile infection 13.31 11.95 32 20717 15751 29915978
Peritumoural oedema 13.30 11.95 3 20746 16 29931713
Neuromuscular block prolonged 13.19 11.95 6 20743 363 29931366
Carditis 13.17 11.95 4 20745 76 29931653
Frequent bowel movements 13.07 11.95 22 20727 8383 29923346
Dysprosody 13.00 11.95 3 20746 18 29931711
Malnutrition 12.81 11.95 26 20723 11423 29920306
Apparent life threatening event 12.63 11.95 5 20744 214 29931515
Adulterated product 12.60 11.95 3 20746 21 29931708
Blood pressure decreased 12.47 11.95 65 20684 47010 29884719
Dry skin 12.42 11.95 39 20710 22415 29909314
Intestinal mass 12.24 11.95 6 20743 430 29931299
Anterior chamber flare 12.22 11.95 4 20745 98 29931631
Blood albumin abnormal 12.07 11.95 5 20744 241 29931488
Salivary hypersecretion 12.03 11.95 20 20729 7546 29924183
Gastrointestinal scarring 12.03 11.95 4 20745 103 29931626
Apnoea 11.97 11.95 18 20731 6240 29925489
Ill-defined disorder 11.96 11.95 24 20725 10460 29921269

Pharmacologic Action:

SourceCodeDescription
ATC A03BA01 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
BELLADONNA AND DERIVATIVES, PLAIN
Belladonna alkaloids, tertiary amines
ATC A03CB03 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
ANTISPASMODICS IN COMBINATION WITH PSYCHOLEPTICS
Belladonna and derivatives in combination with psycholeptics
ATC S01FA01 SENSORY ORGANS
OPHTHALMOLOGICALS
MYDRIATICS AND CYCLOPLEGICS
Anticholinergics
MeSH PA D000759 Adjuvants, Anesthesia
MeSH PA D000889 Anti-Arrhythmia Agents
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D001993 Bronchodilator Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D018678 Cholinergic Agents
MeSH PA D018680 Cholinergic Antagonists
MeSH PA D018727 Muscarinic Antagonists
MeSH PA D009184 Mydriatics
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D010276 Parasympatholytics
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D019141 Respiratory System Agents
FDA MoA N0000000125 Cholinergic Muscarinic Antagonists
FDA MoA N0000175370 Cholinergic Antagonists
FDA EPC N0000175574 Anticholinergic
FDA EPC N0000175700 Cholinergic Muscarinic Antagonist
CHEBI has role CHEBI:35523 bronchodilator agents
CHEBI has role CHEBI:38070 antiarrhythmic agent
CHEBI has role CHEBI:48876 antimuskarinika
CHEBI has role CHEBI:50370 parasympatholytics
CHEBI has role CHEBI:50513 mydriatics
CHEBI has role CHEBI:60807 anaesthesia adjuvants
CHEBI has role CHEBI:76924 plant metabolites
CHEBI has role CHEBI:146270 oneirogens

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Perioperative Mydriasis indication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.24 acidic
pKa2 9.26 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
8MG/20ML (0.4MG/ML) ATROPINE SULFATE ACCORD HLTHCARE A213424 March 19, 2021 RX SOLUTION INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL Sept. 21, 2021 COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Muscarinic acetylcholine receptor M3 GPCR ANTAGONIST Ki 9.50 WOMBAT-PK CHEMBL
Muscarinic acetylcholine receptor M2 GPCR ANTAGONIST Ki 8.97 WOMBAT-PK CHEMBL
Muscarinic acetylcholine receptor M1 GPCR ANTAGONIST Ki 9.31 WOMBAT-PK CHEMBL
Alpha-1D adrenergic receptor GPCR Ki 6.18 DRUG MATRIX
Solute carrier family 22 member 1 Transporter IC50 4.91 CHEMBL
Histamine H1 receptor GPCR Ki 5.91 PDSP
Muscarinic acetylcholine receptor M5 GPCR Ki 9.29 WOMBAT-PK
5-hydroxytryptamine receptor 2A GPCR Ki 5.15 PDSP
Muscarinic acetylcholine receptor M4 GPCR Ki 9.39 WOMBAT-PK
5-hydroxytryptamine receptor 2C GPCR Ki 6.28 DRUG MATRIX
Muscarinic receptor M1 GPCR Ki 9.70 CHEMBL
Muscarinic acetylcholine receptor M2 GPCR Ki 9.15 CHEMBL
Muscarinic acetylcholine receptor M5 GPCR Ki 9.07 CHEMBL
Muscarinic acetylcholine receptor M2 GPCR Ki 9.46 CHEMBL
Muscarinic acetylcholine receptor M1 GPCR Ki 9.59 CHEMBL
Nicotinic acetylcholine receptor alpha 5 subunit Ion channel Ki 4.49 CHEMBL
Acetylcholinesterase Enzyme Ki 9.46 CHEMBL
Muscarinic acetylcholine receptor M3 GPCR Ki 9.92 CHEMBL
Muscarinic acetylcholine receptor M4 GPCR Ki 9.28 CHEMBL
Muscarinic acetylcholine receptor GPCR Ki 9.52 CHEMBL

External reference:

IDSource
7C0697DR9I UNII
4019591 VUID
N0000147687 NUI
D00113 KEGG_DRUG
5908-99-6 SECONDARY_CAS_RN
4017410 VANDF
4019591 VANDF
C0004259 UMLSCUI
CHEBI:16684 CHEBI
OIN PDB_CHEM_ID
CHEMBL517712 ChEMBL_ID
CHEMBL2146146 ChEMBL_ID
174174 PUBCHEM_CID
DB00572 DRUGBANK_ID
D001285 MESH_DESCRIPTOR_UI
320 IUPHAR_LIGAND_ID
1223 RXNORM
27333 MMSL
405 MMSL
4229 MMSL
d00174 MMSL
001715 NDDF
001717 NDDF
372832002 SNOMEDCT_US
73949004 SNOMEDCT_US
74237004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Diphenoxylate Hydrochloride and Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 2 0054-3194 SOLUTION 0.03 mg ORAL ANDA 20 sections
Isopto Atropine HUMAN PRESCRIPTION DRUG LABEL 1 0065-0303 SOLUTION 10 mg OPHTHALMIC NDA 26 sections
Diphenoxylate Hydrochloride and Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 2 0378-0415 TABLET 0.03 mg ORAL ANDA 20 sections
Diphenoxylate Hydrochloride and Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 2 0406-1236 TABLET 0.03 mg ORAL ANDA 23 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0409-1630 INJECTION, SOLUTION 0.10 mg INTRAMUSCULAR NDA 23 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0409-4910 INJECTION, SOLUTION 0.10 mg INTRAVENOUS NDA 23 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0409-4911 INJECTION, SOLUTION 0.10 mg INTRAVENOUS NDA 23 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0409-9630 INJECTION, SOLUTION 0.05 mg INTRAMUSCULAR NDA 23 sections
Belladonna Alkaloids with Phenobartbital HUMAN PRESCRIPTION DRUG LABEL 4 0440-7183 TABLET 0.02 mg ORAL UNULLPPROVED DRUG OTHER 14 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0517-0401 INJECTION, SOLUTION 0.40 mg INTRAMUSCULAR UNULLPPROVED DRUG OTHER 11 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0517-1010 INJECTION, SOLUTION 1 mg INTRAMUSCULAR UNULLPPROVED DRUG OTHER 11 sections
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE HUMAN PRESCRIPTION DRUG LABEL 2 0527-1170 TABLET 0.03 mg ORAL ANDA 12 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6006 INJECTION 0.40 mg INTRAMUSCULAR unapproved drug other 16 sections
Diphenoxylate hydrochloride and atropine sulfate HUMAN PRESCRIPTION DRUG LABEL 2 0832-0590 TABLET 0.03 mg ORAL ANDA 21 sections
ATROPEN Auto-Injector HUMAN PRESCRIPTION DRUG LABEL 1 11704-101 INJECTION 2 mg INTRAMUSCULAR NDA 26 sections
ATROPEN Auto-Injector HUMAN PRESCRIPTION DRUG LABEL 1 11704-104 INJECTION 0.50 mg INTRAMUSCULAR NDA 26 sections
ATROPEN Auto-Injector HUMAN PRESCRIPTION DRUG LABEL 1 11704-105 INJECTION 1 mg INTRAMUSCULAR NDA 26 sections
ATROPEN Auto-Injector HUMAN PRESCRIPTION DRUG LABEL 1 11704-106 INJECTION 2 mg INTRAMUSCULAR NDA 26 sections
ATROPEN Auto-Injector HUMAN PRESCRIPTION DRUG LABEL 1 11704-107 INJECTION 0.25 mg INTRAMUSCULAR NDA 26 sections
Diphenoxylate Hydrochloride and Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 2 12634-531 TABLET 0.03 mg ORAL ANDA 21 sections
Atropine HUMAN PRESCRIPTION DRUG LABEL 1 13985-606 SOLUTION/ DROPS 10 mg OPHTHALMIC NDA 26 sections
Diphenoxylate Hcl and Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 2 16590-080 TABLET 0.03 mg ORAL ANDA 13 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 16729-512 INJECTION, SOLUTION 0.40 mg INTRAVENOUS ANDA 22 sections
ATROPINE SULFATE HUMAN PRESCRIPTION DRUG LABEL 1 16729-525 INJECTION, SOLUTION 0.40 mg INTRAVENOUS NDA 23 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 16729-526 INJECTION, SOLUTION 1 mg INTRAVENOUS NDA 23 sections
Atropine HUMAN PRESCRIPTION DRUG LABEL 1 17478-215 SOLUTION/ DROPS 10 mg OPHTHALMIC NDA 26 sections
Phenohytro HUMAN PRESCRIPTION DRUG LABEL 4 17856-0123 ELIXIR 0.02 mg ORAL UNULLPPROVED DRUG OTHER 18 sections
Phenohytro HUMAN PRESCRIPTION DRUG LABEL 4 17856-0125 ELIXIR 0.02 mg ORAL UNULLPPROVED DRUG OTHER 18 sections
PHENOBARBITAL WITH BELLADONNULL ALKALOIDS HUMAN PRESCRIPTION DRUG LABEL 4 17856-0162 ELIXIR 0.02 mg ORAL unapproved drug other 16 sections
Donnatal HUMAN PRESCRIPTION DRUG LABEL 4 17856-0423 ELIXIR 0.02 mg ORAL unapproved drug other 12 sections