dexmedetomidine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
835 113775-47-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • dexmedetomidine
  • (S)-Medetomidine
  • dexmedetomidine hydrochloride
  • dexdor
  • dexmedetomidine HCl
  • MPV1440
A imidazole derivative that is an agonist of ADRENERGIC ALPHA-2 RECEPTORS. It is closely-related to MEDETOMIDINE, which is the racemic form of this compound.
  • Molecular weight: 200.29
  • Formula: C13H16N2
  • CLOGP: 3.10
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 28.68
  • ALOGS: -3.06
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1 mg P

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.09 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 1.60 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 11 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.06 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.20 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 17, 1999 FDA HOSPIRA
Jan. 29, 2001 PMDA Abbott Japan, Maruishi Pharmaceutical

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
Bradycardia 186.95 34.75 89 3253 64337 50537445
Product administered to patient of inappropriate age 99.50 34.75 25 3317 2605 50599177
Upper airway obstruction 80.83 34.75 16 3326 557 50601225
Delirium 78.88 34.75 42 3300 38150 50563632
Floppy iris syndrome 75.90 34.75 12 3330 108 50601674
Hypotension 73.94 34.75 84 3258 235385 50366397
Agitation 70.84 34.75 44 3298 53340 50548442
Glossoptosis 66.96 34.75 10 3332 59 50601723
Respiratory acidosis 66.74 34.75 22 3320 6006 50595776
Respiratory depression 65.62 34.75 26 3316 11984 50589798
Sinus arrest 63.52 34.75 16 3326 1682 50600100
Cardiac arrest 61.57 34.75 48 3294 83603 50518179
Laryngeal stenosis 58.70 34.75 13 3329 784 50600998
Generalised tonic-clonic seizure 54.48 34.75 29 3313 26281 50575501
Tachyphylaxis 53.55 34.75 10 3332 254 50601528
Hepatic function abnormal 51.23 34.75 30 3312 32651 50569131
Withdrawal syndrome 49.92 34.75 24 3318 17566 50584216
Local anaesthetic systemic toxicity 45.17 34.75 10 3332 602 50601180
Product closure removal difficult 44.24 34.75 6 3336 15 50601767
Respiratory failure 43.85 34.75 41 3301 91140 50510642
Ventricular dysfunction 43.34 34.75 13 3329 2608 50599174
Acute respiratory distress syndrome 42.95 34.75 23 3319 21076 50580706
Abdominal compartment syndrome 40.73 34.75 9 3333 537 50601245
Hyperthermia 39.73 34.75 16 3326 7680 50594102
Aplastic anaemia 39.72 34.75 16 3326 7687 50594095
Laryngospasm 38.76 34.75 12 3330 2676 50599106
Drug interaction 37.01 34.75 55 3287 199566 50402216
Device pacing issue 36.30 34.75 6 3336 73 50601709
Myoclonus 35.84 34.75 18 3324 14452 50587330
Hypernatraemia 35.62 34.75 14 3328 6307 50595475

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
Bradycardia 232.30 24.34 142 4878 65487 29504020
Cardiac arrest 157.61 24.34 124 4896 85467 29484040
Hyperthermia 144.97 24.34 56 4964 9374 29560133
Diabetes insipidus 134.37 24.34 38 4982 2396 29567111
Product administered to patient of inappropriate age 88.15 24.34 28 4992 2627 29566880
Delirium 87.57 24.34 64 4956 39333 29530174
Arteriospasm coronary 84.95 24.34 27 4993 2538 29566969
Seizure like phenomena 79.68 24.34 19 5001 607 29568900
Postoperative ileus 74.12 24.34 18 5002 622 29568885
Hyperthermia malignant 72.63 24.34 22 4998 1762 29567745
Intestinal pseudo-obstruction 70.58 24.34 20 5000 1268 29568239
Drug withdrawal syndrome 68.70 24.34 41 4979 17943 29551564
Hypotension 66.11 24.34 118 4902 194236 29375271
Acute motor axonal neuropathy 58.75 24.34 10 5010 51 29569456
Electrocardiogram QT prolonged 55.01 24.34 47 4973 36090 29533417
Burkholderia test positive 52.43 24.34 15 5005 984 29568523
Myoclonus 49.92 24.34 30 4990 13279 29556228
Respiratory failure 49.45 24.34 71 4949 97060 29472447
Epidermolysis bullosa 46.08 24.34 9 5011 108 29569399
Off label use 45.10 24.34 132 4888 300668 29268839
Upper airway obstruction 45.03 24.34 12 5008 604 29568903
Polyuria 42.39 24.34 22 4998 7340 29562167
Malignant catatonia 39.97 24.34 9 5011 222 29569285
Serotonin syndrome 37.83 24.34 28 4992 17484 29552023
Laryngomalacia 37.25 24.34 9 5011 304 29569203
Tachypnoea 34.53 24.34 25 4995 15090 29554417
Agitation 34.49 24.34 43 4977 51261 29518246
Fatigue 32.72 24.34 7 5013 316814 29252693
Tachycardia 32.59 24.34 50 4970 72360 29497147
Floppy iris syndrome 32.33 24.34 8 5012 299 29569208
Hypernatraemia 31.24 24.34 18 5002 7368 29562139
Macule 30.78 24.34 10 5010 1006 29568501
Urinary bladder rupture 29.86 24.34 6 5014 84 29569423
Product use issue 29.71 24.34 40 4980 51404 29518103
Cardiac arrest neonatal 29.13 24.34 5 5015 27 29569480
Ventricular fibrillation 29.11 24.34 23 4997 15810 29553697
Neuroleptic malignant syndrome 28.71 24.34 23 4997 16125 29553382
Sedation complication 28.50 24.34 10 5010 1272 29568235
Abdominal compartment syndrome 28.47 24.34 9 5011 830 29568677
Drug withdrawal syndrome neonatal 28.10 24.34 13 5007 3382 29566125
Glossoptosis 27.57 24.34 6 5014 126 29569381
Torsade de pointes 27.55 24.34 16 5004 6645 29562862
Sinus arrest 27.32 24.34 10 5010 1437 29568070
Transcranial electrical motor evoked potential monitoring abnormal 25.18 24.34 4 5016 12 29569495
Multiple organ dysfunction syndrome 24.83 24.34 41 4979 63075 29506432
Methaemoglobinaemia 24.54 24.34 11 5009 2660 29566847
Postresuscitation encephalopathy 24.50 24.34 4 5016 15 29569492

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
Bradycardia 348.82 25.17 203 7736 118016 64372777
Cardiac arrest 201.45 25.17 160 7779 153904 64336889
Hyperthermia 180.56 25.17 69 7870 15481 64475312
Diabetes insipidus 140.26 25.17 42 7897 4479 64486314
Product administered to patient of inappropriate age 139.54 25.17 42 7897 4559 64486234
Delirium 124.08 25.17 87 7852 69107 64421686
Postoperative ileus 108.48 25.17 25 7914 956 64489837
Upper airway obstruction 107.41 25.17 26 7913 1232 64489561
Hypotension 103.40 25.17 175 7764 380799 64109994
Respiratory depression 92.79 25.17 49 7890 23394 64467399
Agitation 90.81 25.17 80 7859 88287 64402506
Myoclonus 84.12 25.17 47 7892 25071 64465722
Drug withdrawal syndrome 79.60 25.17 49 7890 31242 64459551
Polyuria 75.59 25.17 35 7904 12608 64478185
Respiratory failure 75.57 25.17 96 7843 161087 64329706
Glossoptosis 75.27 25.17 14 7925 180 64490613
Hyperthermia malignant 72.63 25.17 22 7917 2437 64488356
Generalised tonic-clonic seizure 71.11 25.17 50 7889 39807 64450986
Intestinal pseudo-obstruction 68.22 25.17 20 7919 1980 64488813
Electrocardiogram QT prolonged 68.09 25.17 65 7874 79383 64411410
Sinus arrest 67.68 25.17 22 7917 3068 64487725
Seizure like phenomena 67.44 25.17 19 7920 1633 64489160
Off label use 65.54 25.17 198 7741 632608 63858185
Abdominal compartment syndrome 65.52 25.17 18 7921 1410 64489383
Serotonin syndrome 64.84 25.17 47 7892 39235 64451558
Hypernatraemia 64.43 25.17 31 7908 12158 64478635
Tachypnoea 63.51 25.17 40 7899 26531 64464262
Respiratory acidosis 58.03 25.17 27 7912 9828 64480965
Acute motor axonal neuropathy 56.34 25.17 10 7929 97 64490696
Withdrawal syndrome 55.23 25.17 35 7904 23457 64467336
Drug interaction 53.12 25.17 129 7810 361954 64128839
Laryngeal stenosis 50.48 25.17 13 7926 794 64489999
Tachycardia 48.95 25.17 75 7864 149504 64341289
Atrioventricular block second degree 48.59 25.17 21 7918 6433 64484360
Arteriospasm coronary 48.54 25.17 20 7919 5445 64485348
Epidermolysis bullosa 43.29 25.17 9 7930 211 64490582
Arthralgia 42.91 25.17 3 7936 442257 64048536
Delayed recovery from anaesthesia 42.26 25.17 13 7926 1515 64489278
Multiple organ dysfunction syndrome 42.17 25.17 57 7882 101356 64389437
Fatigue 41.93 25.17 20 7919 748710 63742083
Product closure removal difficult 40.02 25.17 5 7934 0 64490793
Laryngospasm 38.93 25.17 15 7924 3430 64487363
Hypoxia 38.88 25.17 51 7888 88098 64402695
Torsade de pointes 38.66 25.17 25 7914 17338 64473455
Malignant catatonia 38.46 25.17 9 7930 368 64490425
Ventricular fibrillation 38.11 25.17 28 7911 23832 64466961
Local anaesthetic systemic toxicity 37.85 25.17 10 7929 675 64490118
Hepatic function abnormal 37.76 25.17 43 7896 64270 64426523
Ventricular tachycardia 37.11 25.17 32 7907 34233 64456560
Neuroleptic malignant syndrome 36.95 25.17 28 7911 24968 64465825
Drug reaction with eosinophilia and systemic symptoms 36.59 25.17 39 7900 54178 64436615
Sedation complication 36.36 25.17 20 7919 10334 64480459
Burkholderia test positive 34.62 25.17 9 7930 570 64490223
Nausea 34.31 25.17 28 7911 785772 63705021
Blood pressure decreased 33.65 25.17 47 7892 86152 64404641
Acute respiratory distress syndrome 33.60 25.17 32 7907 38903 64451890
Transcranial electrical motor evoked potential monitoring abnormal 32.84 25.17 5 7934 16 64490777
Product use in unapproved indication 32.57 25.17 69 7870 176549 64314244
Airway complication of anaesthesia 32.54 25.17 8 7931 404 64490389
Malaise 32.51 25.17 5 7934 396242 64094551
Device pacing issue 31.65 25.17 6 7933 86 64490707
Oxygen saturation decreased 31.25 25.17 51 7888 107125 64383668
Sinus bradycardia 30.26 25.17 24 7915 22869 64467924
Anaphylactic shock 30.19 25.17 27 7912 30301 64460492
Diarrhoea 30.01 25.17 27 7912 722677 63768116
Headache 28.30 25.17 15 7924 529452 63961341
Dizziness 28.12 25.17 9 7930 430154 64060639
Asthenia 27.90 25.17 9 7930 428035 64062758
Stress cardiomyopathy 27.43 25.17 16 7923 9241 64481552
Pain in extremity 26.82 25.17 3 7936 303082 64187711
Ventricular dysfunction 26.63 25.17 13 7926 5257 64485536
Aplastic anaemia 26.06 25.17 18 7921 13902 64476891
Drug ineffective for unapproved indication 25.75 25.17 25 7914 31108 64459685
Atrioventricular block complete 25.49 25.17 18 7921 14400 64476393
Macule 25.42 25.17 10 7929 2416 64488377
Product use issue 25.37 25.17 57 7882 151658 64339135
Septic shock 25.26 25.17 46 7893 105391 64385402

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N05CM18 NERVOUS SYSTEM
PSYCHOLEPTICS
HYPNOTICS AND SEDATIVES
Other hypnotics and sedatives
FDA MoA N0000009918 Adrenergic alpha2-Agonists
FDA EPC N0000175554 Central alpha-2 Adrenergic Agonist
CHEBI has role CHEBI:35569 alpha-adrenergic agonists
CHEBI has role CHEBI:35717 hypnotics
FDA PE N0000175975 General Anesthesia
MeSH PA D018663 Adrenergic Agents
MeSH PA D000322 Adrenergic Agonists
MeSH PA D058647 Adrenergic alpha-2 Receptor Agonists
MeSH PA D000316 Adrenergic alpha-Agonists
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D006993 Hypnotics and Sedatives
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Conscious sedation indication 314271007
Complete atrioventricular block contraindication 27885002
Hypovolemia contraindication 28560003
Hypertensive disorder contraindication 38341003 DOID:10763
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Diabetes mellitus contraindication 73211009 DOID:9351
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409
Cardiac Decompensation contraindication




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Cats Preanesthesia to general anesthesia Indication
Cats Sedation and analgesia Indication
Dogs Preanesthesia to general anesthesia Indication
Dogs Sedation and analgesia Indication
Dogs Noise aversion Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Dexdomitor Orion Corp. 1
SILEO Orion Corp. 1
Dexmedesed Dechra Veterinary Products LLC 1
Dexmedetomidine Hydrochloride Injection Akorn Animal Health Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.36 acidic
pKa2 6.76 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) PRECEDEX HOSPIRA N021038 March 13, 2013 RX INJECTABLE INJECTION 8455527 Jan. 4, 2032 USE FOR SEDATION
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) PRECEDEX HOSPIRA N021038 March 13, 2013 RX INJECTABLE INJECTION 8455527 Jan. 4, 2032 USE FOR SEDATION
EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) PRECEDEX HOSPIRA N021038 Nov. 14, 2014 RX INJECTABLE INJECTION 8455527 Jan. 4, 2032 USE FOR SEDATION
EQ 0.12MG BASE IGALMI BIOXCEL N215390 April 5, 2022 RX FILM BUCCAL, SUBLINGUAL 10792246 June 26, 2039 ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL ADMINISTRATION
EQ 0.18MG BASE IGALMI BIOXCEL N215390 April 5, 2022 RX FILM BUCCAL, SUBLINGUAL 10792246 June 26, 2039 ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL ADMINISTRATION

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 0.12MG BASE IGALMI BIOXCEL N215390 April 5, 2022 RX FILM BUCCAL, SUBLINGUAL April 5, 2025 NEW PRODUCT
EQ 0.18MG BASE IGALMI BIOXCEL N215390 April 5, 2022 RX FILM BUCCAL, SUBLINGUAL April 5, 2025 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Alpha-2B adrenergic receptor GPCR AGONIST Ki 9.70 IUPHAR CHEMBL
Alpha-2C adrenergic receptor GPCR AGONIST Ki 9.30 IUPHAR CHEMBL
Alpha-2A adrenergic receptor GPCR AGONIST EC50 8.82 CHEMBL CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 6.50 PDSP
Alpha-1A adrenergic receptor GPCR Ki 6.70 PDSP
Alpha-1D adrenergic receptor GPCR Ki 10.82 CHEMBL
Alpha-2A adrenergic receptor GPCR Ki 10.82 CHEMBL
Alpha-1A adrenergic receptor GPCR EC50 6.42 CHEMBL
Adrenergic receptor alpha-2 GPCR Ki 10.82 CHEMBL
Adrenergic receptor alpha-1 GPCR Ki 8.30 CHEMBL
Alpha-1B adrenergic receptor GPCR EC50 6.44 CHEMBL

External reference:

IDSource
4021214 VUID
N0000148660 NUI
D00514 KEGG_DRUG
145108-58-3 SECONDARY_CAS_RN
228054 RXNORM
4021214 VANDF
4021215 VANDF
C0113293 UMLSCUI
CHEBI:4466 CHEBI
CZX PDB_CHEM_ID
CHEMBL778 ChEMBL_ID
DB00633 DRUGBANK_ID
CHEMBL2106195 ChEMBL_ID
D020927 MESH_DESCRIPTOR_UI
5311068 PUBCHEM_CID
6277 INN_ID
521 IUPHAR_LIGAND_ID
67VB76HONO UNII
227894 MMSL
29394 MMSL
8598 MMSL
d04505 MMSL
008084 NDDF
008085 NDDF
116348007 SNOMEDCT_US
437750002 SNOMEDCT_US
438079000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Dexmedetomidine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9525 INJECTION, SOLUTION 4 ug INTRAVENOUS ANDA 30 sections
Dexmedetomidine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9526 INJECTION, SOLUTION 4 ug INTRAVENOUS ANDA 30 sections
Dexmedetomidine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0143-9532 INJECTION 100 ug INTRAVENOUS ANDA 29 sections
DEXMEDETOMIDINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0338-9555 INJECTION 200 ug INTRAVENOUS ANDA 30 sections
DEXMEDETOMIDINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0338-9557 INJECTION 400 ug INTRAVENOUS ANDA 30 sections
PRECEDEX HUMAN PRESCRIPTION DRUG LABEL 1 0404-9938 INJECTION, SOLUTION, CONCENTRATE 100 ug INTRAVENOUS NDA 17 sections
Precedex HUMAN PRESCRIPTION DRUG LABEL 1 0409-1174 INJECTION, SOLUTION 4 ug INTRAVENOUS NDA 35 sections
Precedex HUMAN PRESCRIPTION DRUG LABEL 1 0409-1434 INJECTION, SOLUTION 4 ug INTRAVENOUS NDA 34 sections
Precedex HUMAN PRESCRIPTION DRUG LABEL 1 0409-1434 INJECTION, SOLUTION 4 ug INTRAVENOUS NDA 34 sections
Precedex HUMAN PRESCRIPTION DRUG LABEL 1 0409-1454 INJECTION, SOLUTION 4 ug INTRAVENOUS NDA 35 sections
Precedex HUMAN PRESCRIPTION DRUG LABEL 1 0409-1638 INJECTION, SOLUTION, CONCENTRATE 100 ug INTRAVENOUS NDA 34 sections
Precedex HUMAN PRESCRIPTION DRUG LABEL 1 0409-1638 INJECTION, SOLUTION, CONCENTRATE 100 ug INTRAVENOUS NDA 34 sections
Precedex HUMAN PRESCRIPTION DRUG LABEL 1 0409-1660 INJECTION, SOLUTION 4 ug INTRAVENOUS NDA 34 sections
Precedex HUMAN PRESCRIPTION DRUG LABEL 1 0409-1660 INJECTION, SOLUTION 4 ug INTRAVENOUS NDA 34 sections
Precedex HUMAN PRESCRIPTION DRUG LABEL 1 0409-3301 INJECTION, SOLUTION 4 ug INTRAVENOUS NDA 35 sections
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0781-3493 INJECTION 4 ug INTRAVENOUS ANDA 29 sections
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0781-3494 INJECTION 4 ug INTRAVENOUS ANDA 29 sections
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0781-3495 INJECTION 4 ug INTRAVENOUS ANDA 29 sections
Dexmedetomidine HUMAN PRESCRIPTION DRUG LABEL 1 16729-239 INJECTION, SOLUTION 100 ug INTRAVENOUS ANDA 28 sections
DEXMEDETOMIDINE HUMAN PRESCRIPTION DRUG LABEL 1 16729-432 INJECTION, SOLUTION 100 ug INTRAVENOUS ANDA 28 sections
Dexmedetomidine HUMAN PRESCRIPTION DRUG LABEL 1 17478-055 INJECTION, SOLUTION, CONCENTRATE 100 ug INTRAVENOUS ANDA 32 sections
Dexmedetomidine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42023-146 INJECTION, SOLUTION, CONCENTRATE 100 ug INTRAVENOUS ANDA 32 sections
Dexmedetomidine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42023-186 INJECTION, SOLUTION 4 ug INTRAVENOUS ANDA 32 sections
Dexmedetomidine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42023-187 INJECTION, SOLUTION 4 ug INTRAVENOUS ANDA 32 sections
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 43066-555 INJECTION 200 ug INTRAVENOUS ANDA 30 sections
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 43066-557 INJECTION 400 ug INTRAVENOUS ANDA 30 sections
DEXMEDETOMIDINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 43066-561 INJECTION 200 ug INTRAVENOUS ANDA 30 sections
DEXMEDETOMIDINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 43066-565 INJECTION 400 ug INTRAVENOUS ANDA 30 sections
DEXMEDETOMIDINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 43598-975 INJECTION, SOLUTION 4 ug INTRAVENOUS ANDA 29 sections
DEXMEDETOMIDINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 43598-976 INJECTION, SOLUTION 4 ug INTRAVENOUS ANDA 29 sections