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 322.36 10.87 932 29645 624614 52693875
Therapy interrupted 139.60 10.87 104 30473 19332 53299157
Macular degeneration 128.43 10.87 83 30494 12278 53306211
Death 118.99 10.87 461 30116 356771 52961718
Dehydration 117.43 10.87 282 30295 168128 53150361
Stress cardiomyopathy 102.76 10.87 63 30514 8499 53309990
Bradycardia 75.00 10.87 141 30436 70915 53247574
Rheumatoid arthritis 74.53 10.87 44 30533 314487 53004002
Blood magnesium increased 56.70 10.87 30 30547 3057 53315432
Pleural thickening 54.91 10.87 28 30549 2644 53315845
Therapy cessation 50.63 10.87 71 30506 27954 53290535
Presbyacusis 49.15 10.87 27 30550 2965 53315524
Abdominal pain 48.01 10.87 280 30297 255623 53062866
Pleural fibrosis 47.04 10.87 28 30549 3580 53314909
Bone cyst 42.61 10.87 22 30555 2132 53316357
Deafness neurosensory 42.19 10.87 29 30548 4749 53313740
Systemic lupus erythematosus 40.29 10.87 11 30566 125403 53193086
Joint swelling 39.26 10.87 46 30531 234592 53083897
Osteosclerosis 38.45 10.87 25 30552 3733 53314756
Small intestinal obstruction 37.98 10.87 48 30529 17099 53301390
Lower respiratory tract infection 37.91 10.87 4 30573 90977 53227512
Synovitis 37.53 10.87 8 30569 107885 53210604
Contraindicated product administered 36.51 10.87 16 30561 135613 53182876
Hypotension 34.82 10.87 257 30320 253819 53064670
Vomiting 33.92 10.87 434 30143 496705 52821784
Glossodynia 33.75 10.87 8 30569 100283 53218206
Epigastric discomfort 33.47 10.87 28 30549 6145 53312344
Swelling 32.46 10.87 37 30540 191068 53127421
Hospitalisation 30.65 10.87 100 30477 70912 53247577
Haemodynamic instability 29.14 10.87 30 30547 8564 53309925
Drug monitoring procedure not performed 28.61 10.87 11 30566 528 53317961
Cyst 28.37 10.87 36 30541 12875 53305614
Intestinal obstruction 27.81 10.87 55 30522 28686 53289803
Neuropathy peripheral 26.28 10.87 123 30454 103064 53215425
Cardiac arrest 25.59 10.87 114 30463 93553 53224936
Respiratory depression 25.48 10.87 34 30543 12772 53305717
Enzyme induction 25.01 10.87 6 30571 54 53318435
Anticholinergic syndrome 24.97 10.87 15 30562 1949 53316540
Bulimia nervosa 24.94 10.87 10 30567 537 53317952
Arthralgia 23.86 10.87 151 30426 439632 52878857
Polydipsia 23.78 10.87 18 30559 3422 53315067
Short-bowel syndrome 23 10.87 9 30568 453 53318036
Ventricular asystole 22.79 10.87 6 30571 81 53318408
Anterior spinal artery syndrome 22.72 10.87 6 30571 82 53318407
Anorectal disorder 22.49 10.87 13 30564 1574 53316915
Maternal exposure during pregnancy 22.46 10.87 34 30543 155605 53162884
Completed suicide 22.14 10.87 28 30549 138173 53180316
Blood potassium increased 22.12 10.87 38 30539 17803 53300686
Gastroenteritis radiation 22.04 10.87 9 30568 507 53317982
Neuromuscular blockade 21.82 10.87 8 30569 336 53318153
Discomfort 21.66 10.87 14 30563 95458 53223031
Surgery 21.64 10.87 53 30524 31911 53286578
Osteopenia 21.34 10.87 38 30539 18317 53300172
Hyperthermia malignant 21.22 10.87 10 30567 795 53317694
Cardiac assistance device user 20.94 10.87 5 30572 44 53318445
Ileostomy 20.51 10.87 11 30566 1152 53317337
Purpura senile 20.42 10.87 9 30568 613 53317876
Mental status changes 20.11 10.87 59 30518 39512 53278977
Pulmonary oedema 19.98 10.87 72 30505 53651 53264838
Weight decreased 19.43 10.87 213 30364 234735 53083754
Mydriasis 19.43 10.87 28 30549 11298 53307191
Drug abuse 18.81 10.87 7 30570 65519 53252970
Skin lesion 18.78 10.87 47 30530 28682 53289807
Wound 18.71 10.87 15 30562 91542 53226947
Rash 18.57 10.87 165 30412 446026 52872463
Arthropathy 18.45 10.87 33 30544 141420 53177069
Dysarthria 18.29 10.87 58 30519 40510 53277979
Disseminated intravascular coagulation 18.19 10.87 37 30540 19682 53298807
Neuromuscular block prolonged 18.15 10.87 8 30569 545 53317944
Agitation postoperative 17.56 10.87 4 30573 28 53318461
Blood potassium decreased 17.47 10.87 57 30520 40403 53278086
Deformity 17.19 10.87 22 30555 7932 53310557
Ventricular tachycardia 17.19 10.87 34 30543 17728 53300761
Abortion spontaneous 17.18 10.87 3 30574 46632 53271857
Abdominal discomfort 17.07 10.87 67 30510 220995 53097494
Tarsal tunnel syndrome 16.97 10.87 8 30569 637 53317852
Clostridium difficile colitis 16.96 10.87 36 30541 19729 53298760
Ventricular fibrillation 16.93 10.87 27 30550 11898 53306591
Endophthalmitis 16.87 10.87 15 30562 3572 53314917
Exostosis 16.41 10.87 26 30551 11398 53307091
Alopecia 16.32 10.87 74 30503 234509 53083980
N-terminal prohormone brain natriuretic peptide 15.71 10.87 4 30573 47 53318442
Infusion related reaction 15.70 10.87 42 30535 155915 53162574
Frequent bowel movements 15.69 10.87 29 30548 14383 53304106
Disease progression 15.61 10.87 106 30471 101814 53216675
Anterior chamber flare 15.54 10.87 5 30572 141 53318348
Atrioventricular block complete 15.51 10.87 21 30556 7994 53310495
Hypovolaemia 15.39 10.87 24 30553 10378 53308111
C-reactive protein increased 15.34 10.87 10 30567 67876 53250613
Spleen congestion 15.21 10.87 5 30572 151 53318338
Cardiogenic shock 15.19 10.87 32 30545 17450 53301039
Nausea 15.17 10.87 552 30025 755539 52562950
Dry eye 15.07 10.87 48 30529 33596 53284893
Small intestine operation 14.78 10.87 3 30574 11 53318478
Needle issue 14.54 10.87 19 30558 6993 53311496
Haemoperitoneum 14.38 10.87 12 30565 2625 53315864
Decreased appetite 14.30 10.87 187 30390 214787 53103702
Intentional dose omission 14.27 10.87 16 30561 5029 53313460
Fistula 13.88 10.87 21 30556 8849 53309640
pH body fluid abnormal 13.82 10.87 4 30573 78 53318411
Choroidal detachment 13.64 10.87 5 30572 210 53318279
Gastrointestinal stoma output increased 13.64 10.87 5 30572 210 53318279
Sinus arrest 13.53 10.87 10 30567 1834 53316655
Pain 13.46 10.87 247 30330 588151 52730338
Spinal cord injury 13.41 10.87 7 30570 694 53317795
Weight increased 13.37 10.87 66 30511 204501 53113988
Treatment failure 13.37 10.87 34 30543 128369 53190120
Therapeutic product effect decreased 13.29 10.87 33 30544 125622 53192867
Apparent life threatening event 13.24 10.87 4 30573 91 53318398
Systolic dysfunction 13.07 10.87 9 30568 1478 53317011
Failure to thrive 13.05 10.87 18 30559 6974 53311515
Cerebral congestion 13.05 10.87 3 30574 22 53318467
Pruritus 12.94 10.87 107 30470 293725 53024764
Apnoea 12.87 10.87 19 30558 7834 53310655
Resorption bone increased 12.68 10.87 8 30569 1134 53317355
Intraductal papilloma of breast 12.63 10.87 4 30573 107 53318382
Thrombophlebitis superficial 12.61 10.87 15 30562 5020 53313469
Arteriospasm coronary 12.47 10.87 13 30564 3764 53314725
Psoriatic arthropathy 12.47 10.87 6 30571 48184 53270305
Corneal perforation 12.38 10.87 6 30571 508 53317981
Blood pressure systolic decreased 12.20 10.87 16 30561 5908 53312581
Crohn's disease 12.04 10.87 17 30560 6733 53311756
Injection site erythema 12.00 10.87 16 30561 77233 53241256
Sinus bradycardia 11.85 10.87 26 30551 14575 53303914
Rectal haemorrhage 11.71 10.87 51 30526 41430 53277059
Asthenia 11.60 10.87 268 30309 343322 52975167
Plasma cell myeloma 11.40 10.87 56 30521 47818 53270671
White blood cell count decreased 11.28 10.87 115 30462 124360 53194129
Headache 11.15 10.87 229 30348 536592 52781897
Vestibular disorder 11.14 10.87 8 30569 1403 53317086
Opsoclonus myoclonus 11.12 10.87 4 30573 159 53318330
Anaesthetic complication 10.88 10.87 9 30568 1945 53316544

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 251.81 12.02 688 22155 364114 32126569
Dehydration 85.88 12.02 241 22602 128717 32361966
Death 81.62 12.02 502 22341 382015 32108668
Therapy interrupted 71.14 12.02 53 22790 8025 32482658
Anticholinergic syndrome 60.30 12.02 23 22820 877 32489806
Hyperthermia malignant 54.75 12.02 27 22816 1932 32488751
Bradycardia 39.25 12.02 125 22718 71437 32419246
Therapy cessation 38.89 12.02 52 22791 15961 32474722
Cardiac arrest 35.25 12.02 148 22695 96628 32394055
Fatigue 34.11 12.02 386 22457 350315 32140368
Alopecia 34.02 12.02 56 22787 20674 32470009
Cholinergic syndrome 33.76 12.02 13 22830 509 32490174
Nausea 32.94 12.02 357 22486 320492 32170191
Emotional disorder 29.62 12.02 27 22816 5414 32485269
Change of bowel habit 27.69 12.02 14 22829 1057 32489626
Vomiting 25.00 12.02 264 22579 235293 32255390
Anterior chamber disorder 23.63 12.02 7 22836 120 32490563
Oral pain 23.61 12.02 32 22811 9946 32480737
Stress cardiomyopathy 23.48 12.02 15 22828 1771 32488912
Stoma site pain 23.35 12.02 12 22831 937 32489746
Mouth ulceration 23.18 12.02 34 22809 11367 32479316
Colitis 23.06 12.02 64 22779 33887 32456796
Disease progression 22.25 12.02 120 22723 86742 32403941
Interstitial lung disease 22.08 12.02 9 22834 64992 32425691
Anaesthetic complication 21.74 12.02 12 22831 1083 32489600
Drug interaction 21.38 12.02 80 22763 218105 32272578
Decreased appetite 21.35 12.02 189 22654 160624 32330059
Arteriospasm coronary 21.32 12.02 17 22826 2843 32487840
Pulse absent 21.26 12.02 23 22820 5663 32485020
Corneal oedema 21.23 12.02 13 22830 1425 32489258
Small intestinal obstruction 20.20 12.02 36 22807 14160 32476523
Ventricular fibrillation 19.80 12.02 40 22803 17270 32473413
Drug abuse 19.03 12.02 17 22826 80226 32410457
Mydriasis 18.91 12.02 23 22820 6423 32484260
Vasoplegia syndrome 18.59 12.02 12 22831 1442 32489241
Keratic precipitates 18.52 12.02 6 22837 140 32490543
Limb mass 18.51 12.02 9 22834 624 32490059
Pupil fixed 18.23 12.02 13 22830 1838 32488845
Surgery 17.99 12.02 32 22811 12567 32478116
Electrocardiogram QRS complex prolonged 17.98 12.02 19 22824 4555 32486128
Tachycardia 17.44 12.02 105 22738 78983 32411700
Rebound psychosis 17.22 12.02 6 22837 176 32490507
Dermatitis acneiform 16.82 12.02 21 22822 6024 32484659
Scleritis 16.71 12.02 7 22836 342 32490341
Hypertension 16.53 12.02 153 22690 131597 32359086
Laryngospasm 16.40 12.02 11 22832 1410 32489273
Oesophageal mucosa erythema 16.28 12.02 4 22839 32 32490651
Salivary hypersecretion 16.27 12.02 24 22819 8064 32482619
Keratitis fungal 16.11 12.02 5 22838 101 32490582
Treatment failure 15.81 12.02 4 22839 39159 32451524
Clostridium difficile infection 15.66 12.02 37 22806 17759 32472924
Ileus 15.62 12.02 35 22808 16230 32474453
Agitation postoperative 15.57 12.02 4 22839 39 32490644
Rheumatoid arthritis 15.40 12.02 6 22837 44538 32446145
Proteinuria 15.18 12.02 36 22807 17319 32473364
Anal stenosis 14.99 12.02 5 22838 128 32490555
Blood creatinine decreased 14.99 12.02 14 22829 2895 32487788
Short-bowel syndrome 14.98 12.02 6 22837 261 32490422
Atrioventricular block 14.38 12.02 22 22821 7633 32483050
Sinus tachycardia 14.31 12.02 34 22809 16380 32474303
Acute kidney injury 14.12 12.02 135 22708 293333 32197350
Dry skin 14.01 12.02 44 22799 24934 32465749
Visual acuity tests abnormal 13.88 12.02 4 22839 62 32490621
Apnoea 13.55 12.02 20 22823 6723 32483960
Malnutrition 13.45 12.02 28 22815 12350 32478333
Muscle twitching 13.44 12.02 23 22820 8761 32481922
Pigment dispersion syndrome 13.42 12.02 3 22840 15 32490668
Abdominal pain 13.29 12.02 162 22681 149367 32341316
Choroidal detachment 13.20 12.02 6 22837 357 32490326
Peritumoural oedema 13.11 12.02 3 22840 17 32490666
Product use in unapproved indication 13.01 12.02 26 22817 87178 32403505
Nail bed inflammation 13 12.02 5 22838 195 32490488
Mucosal atrophy 12.97 12.02 4 22839 79 32490604
Dysprosody 12.96 12.02 3 22840 18 32490665
Hypocapnia 12.93 12.02 5 22838 198 32490485
Respiration abnormal 12.74 12.02 13 22830 2992 32487691
Adulterated product 12.56 12.02 3 22840 21 32490662
Carditis 12.40 12.02 4 22839 92 32490591
Apparent life threatening event 12.39 12.02 5 22838 222 32490461
Anal erythema 12.36 12.02 4 22839 93 32490590
Cardiogenic shock 12.15 12.02 37 22806 20625 32470058

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
FDA MoA N0000000125 Cholinergic Muscarinic Antagonists
FDA MoA N0000175370 Cholinergic Antagonists
FDA EPC N0000175574 Anticholinergic
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 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
0.25MG/5ML (0.05MG/ML) ATROPINE SULFATE ACCORD HLTHCARE A212868 July 26, 2021 RX SOLUTION INTRAVENOUS Jan. 26, 2022 COMPETITIVE GENERIC THERAPY
0.5MG/5ML (0.1MG/ML) ATROPINE SULFATE ACCORD HLTHCARE A212868 July 26, 2021 RX SOLUTION INTRAVENOUS Jan. 26, 2022 COMPETITIVE GENERIC THERAPY
1MG/10ML (0.1MG/ML) ATROPINE SULFATE ACCORD HLTHCARE A212868 July 26, 2021 RX SOLUTION INTRAVENOUS Jan. 26, 2022 COMPETITIVE GENERIC THERAPY
1% ATROPINE SULFATE APOTEX INC A215624 Nov. 26, 2021 RX SOLUTION/DROPS OPHTHALMIC May 25, 2022 COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Muscarinic acetylcholine receptor M1 GPCR ANTAGONIST Ki 9.31 WOMBAT-PK CHEMBL
Muscarinic acetylcholine receptor M2 GPCR ANTAGONIST Ki 8.97 WOMBAT-PK CHEMBL
Muscarinic acetylcholine receptor M3 GPCR ANTAGONIST Ki 9.50 WOMBAT-PK CHEMBL
Histamine H1 receptor GPCR Ki 5.91 PDSP
Muscarinic acetylcholine receptor M4 GPCR Ki 9.39 WOMBAT-PK
Muscarinic acetylcholine receptor M5 GPCR Ki 9.29 WOMBAT-PK
Alpha-1D adrenergic receptor GPCR Ki 6.18 DRUG MATRIX
Solute carrier family 22 member 1 Transporter IC50 4.91 CHEMBL
Alpha-2A adrenergic receptor GPCR ANTAGONIST Ki 4.85 IUPHAR
5-hydroxytryptamine receptor 2A GPCR Ki 5.16 PDSP
5-hydroxytryptamine receptor 2C GPCR Ki 6.28 DRUG MATRIX
Muscarinic acetylcholine receptor M2 GPCR Ki 9.15 CHEMBL
Muscarinic acetylcholine receptor M1 GPCR Ki 9.59 CHEMBL
Acetylcholinesterase Enzyme Ki 9.46 CHEMBL
Muscarinic acetylcholine receptor M2 GPCR Ki 9.46 CHEMBL
Muscarinic acetylcholine receptor M3 GPCR Ki 9.92 CHEMBL
Muscarinic receptor M1 GPCR Ki 9.70 CHEMBL
Muscarinic acetylcholine receptor M5 GPCR Ki 9.07 CHEMBL
Muscarinic acetylcholine receptor M4 GPCR Ki 9.28 CHEMBL
Muscarinic acetylcholine receptor GPCR Kd 8.99 CHEMBL
Nicotinic acetylcholine receptor alpha 5 subunit Ion channel Ki 4.49 CHEMBL
Muscarinic acetylcholine receptor GPCR Ki 9.52 CHEMBL

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Lomotil HUMAN PRESCRIPTION DRUG LABEL 2 0025-0061 TABLET 0.03 mg ORAL NDA 23 sections
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
ATROPINE SULFATE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9819 INJECTION, SOLUTION 1 mg INTRAVENOUS unapproved drug other 11 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9820 INJECTION, SOLUTION 0.40 mg INTRAMUSCULAR unapproved drug other 10 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9821 INJECTION, SOLUTION 0.10 mg INTRAVENOUS unapproved drug other 13 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9822 INJECTION, SOLUTION 0.10 mg INTRAMUSCULAR unapproved drug other 14 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9823 INJECTION, SOLUTION 0.05 mg INTRAMUSCULAR NDA 15 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9824 INJECTION 0.40 mg INTRAMUSCULAR unapproved drug other 11 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 INTRAVENOUS 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 INTRAVENOUS NDA 23 sections
Belladonna Alkaloids with Phenobartbital HUMAN PRESCRIPTION DRUG LABEL 4 0440-7183 TABLET 0.02 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0517-0401 INJECTION, SOLUTION 0.40 mg INTRAMUSCULAR UNAPPROVED DRUG OTHER 11 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0517-1010 INJECTION, SOLUTION 1 mg INTRAMUSCULAR UNAPPROVED 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
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6251 INJECTION 0.40 mg ENDOTRACHEAL ANDA 22 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