levosalbutamol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
bronchodilators, phenethylamine derivatives 1575 34391-04-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • xopenex
  • levalbuterol HCl
  • levosalbutamol
  • (-)-Salbutamol
  • (R)-Salbutamol
  • levalbuterol
  • levalbuterol hydrochloride
  • levalbuterol tartrate
The R-isomer of albuterol.
  • Molecular weight: 239.32
  • Formula: C13H21NO3
  • CLOGP: 0.06
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 4
  • TPSA: 72.72
  • ALOGS: -2.05
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 180 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 46 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 2.23 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 44 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -1.459 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.076 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.592 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 3.350 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 89.530 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 81.220 % High 1
herg hERG pIC50 4.056 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 2.642 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.715 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 90.460 % High 1
kinase-safety-class ACVR2A,ACVR2B,AKT2,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK2,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,IGF1R,IKBKB,ITK,JAK2,JAK3,KDR,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PLK1,PLK2,PLK3,PLK4,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 57
kinase-selectivity-class ACVRL1,AXL,BRAF,CDK4,EIF2AK3,EPHB4,GRK2,MAP2K6,TEK,TGFBR1 10
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.782 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.288 High 1
mh-clint Mouse hepatocyte intrinsic clearance 12.274 High 1
mppb Mouse plasma protein binding (% unbound) 92.950 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.227 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 91.100 % High 1
rat-kpuu-brain Rat brain Kpuu 0.009 % High 1
rh-clint Rat hepatocyte intrinsic clearance 5.297 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 91.150 % High 1
rppb Rat plasma protein binding (% unbound) 83.870 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 859.014 uM High 1

Approvals:

DateAgencyCompanyOrphan
March 25, 1999 FDA OAK PHARMS 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 215.18 15.36 232 14884 241928 90371403
Infective pulmonary exacerbation of cystic fibrosis 162.29 15.36 62 15054 10217 90603114
Bronchitis 88.54 15.36 118 14998 152809 90460522
Dyspnoea 85.89 15.36 331 14785 880624 89732707
Sinusitis 82.85 15.36 179 14937 342909 90270422
Product dose omission issue 79.54 15.36 160 14956 291527 90321804
Pneumonia 76.77 15.36 257 14859 637802 89975529
Cough 75.20 15.36 180 14936 368782 90244549
Impaired quality of life 66.99 15.36 44 15072 23100 90590231
Chronic obstructive pulmonary disease 64.07 15.36 70 15046 73759 90539572
Cystic fibrosis 55.91 15.36 22 15094 3919 90609412
Productive cough 54.93 15.36 66 15050 76997 90536334
Chest discomfort 54.35 15.36 89 15027 138276 90475055
Illness 48.54 15.36 64 15052 81905 90531426
Maternal exposure during pregnancy 45.32 15.36 4 15112 360059 90253272
Upper respiratory tract infection 40.55 15.36 75 15041 128243 90485088
Infusion site erythema 39.58 15.36 26 15090 13644 90599687
Nasal congestion 38.78 15.36 58 15058 83356 90529975
Treatment failure 36.61 15.36 4 15112 303924 90309407
Wound 36.46 15.36 4 15112 302976 90310355
Headache 36.38 15.36 257 14859 862489 89750842
Systemic lupus erythematosus 36.29 15.36 8 15108 361888 90251443
COVID-19 36.07 15.36 84 15032 168759 90444572
Acute respiratory failure 34.31 15.36 39 15077 42879 90570452
Pericarditis 33.99 15.36 3 15113 270148 90343183
Pulmonary function test decreased 33.73 15.36 16 15100 4478 90608853
Respiratory tract infection 33.24 15.36 45 15071 59033 90554298
Viral infection 32.04 15.36 37 15079 41377 90571954
Ear infection 31.70 15.36 48 15068 69727 90543604
Drug intolerance 31.16 15.36 18 15098 447573 90165758
Infusion site pain 31.04 15.36 26 15090 19712 90593619
Hepatic enzyme increased 30.56 15.36 11 15105 360725 90252606
Joint swelling 28.78 15.36 25 15091 503275 90110056
Impaired healing 28.41 15.36 3 15113 234196 90379135
General physical health deterioration 28.15 15.36 12 15104 355103 90258228
Sedation complication 28.06 15.36 23 15093 16921 90596410
Creatinine renal clearance decreased 27.89 15.36 24 15092 18875 90594456
Haemoptysis 27.86 15.36 31 15085 33289 90580042
Insurance issue 27.32 15.36 19 15097 10939 90602392
Hospitalisation 26.55 15.36 63 15053 128037 90485294
Postural orthostatic tachycardia syndrome 26.43 15.36 11 15105 2261 90611070
Pseudomonas infection 26.36 15.36 21 15095 14844 90598487
Therapeutic product effect decreased 26.12 15.36 7 15109 277564 90335767
Rheumatoid arthritis 26.07 15.36 14 15102 362600 90250731
Oropharyngeal pain 25.35 15.36 58 15058 115129 90498202
Infusion site bruising 25.18 15.36 13 15103 4359 90608972
Injection site pain 24.43 15.36 74 15042 173625 90439706
Rhinovirus infection 24.02 15.36 14 15102 5949 90607382
Upper-airway cough syndrome 23.93 15.36 20 15096 15115 90598216
Infusion site swelling 23.93 15.36 18 15098 11702 90601629
Anaphylactic reaction 23.77 15.36 48 15068 87476 90525855
Balance disorder 23.75 15.36 51 15065 97029 90516302
Administration site swelling 23.50 15.36 9 15107 1490 90611841
Poor quality device used 23.02 15.36 10 15106 2283 90611048
Infusion related reaction 22.28 15.36 22 15094 416758 90196573
Influenza 22.15 15.36 62 15054 139202 90474129
Blood calcium decreased 21.74 15.36 26 15090 30156 90583175
Dysphonia 21.34 15.36 38 15078 63046 90550285
Discomfort 20.59 15.36 10 15106 274325 90339006
Musculoskeletal stiffness 20.51 15.36 12 15104 296520 90316811
Tracheitis 19.97 15.36 7 15109 903 90612428
Dermatitis atopic 19.90 15.36 22 15094 23450 90589881
No adverse event 19.32 15.36 38 15078 67944 90545387
Infusion site extravasation 19.19 15.36 15 15101 10313 90603018
Renal function test abnormal 19.19 15.36 13 15103 7178 90606153
Arthropathy 18.81 15.36 20 15096 366222 90247109
Alopecia 18.48 15.36 34 15082 495037 90118294
C-reactive protein increased 18.18 15.36 4 15112 181385 90431946
Product quality issue 17.51 15.36 40 15076 79285 90534046
Seizure 16.94 15.36 60 15056 152569 90460762
Enterovirus infection 16.69 15.36 7 15109 1467 90611864
Blister 16.69 15.36 11 15105 254987 90358344
Pre-existing condition improved 16.36 15.36 13 15103 9156 90604175
Therapeutic product effect incomplete 16.26 15.36 6 15110 193890 90419441
Migraine 15.58 15.36 68 15048 190324 90423007

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
Infective pulmonary exacerbation of cystic fibrosis 134.27 18.67 45 4631 7773 42608886
Asthma 104.81 18.67 72 4604 62242 42554417
Coagulation factor deficiency 65.81 18.67 13 4663 264 42616395
Coagulation factor V level abnormal 59.94 18.67 11 4665 148 42616511
Dyspnoea 53.45 18.67 136 4540 442485 42174174
Factor V Leiden mutation 49.52 18.67 10 4666 228 42616431
Cough 47.11 18.67 76 4600 178027 42438632
Sinusitis 44.98 18.67 39 4637 47253 42569406
Pneumonia 41.15 18.67 120 4556 422029 42194630
Toxic optic neuropathy 39.38 18.67 11 4665 1029 42615630
Upper respiratory tract infection 38.53 18.67 34 4642 42139 42574520
Cystic fibrosis 35.94 18.67 12 4664 2043 42614616
Congenital anomaly 35.11 18.67 11 4665 1530 42615129
Bronchopulmonary aspergillosis allergic 33.05 18.67 14 4662 4584 42612075
Multiple allergies 32.39 18.67 13 4663 3715 42612944
Chronic obstructive pulmonary disease 28.72 18.67 35 4641 63079 42553580
Impaired quality of life 27.66 18.67 18 4658 14159 42602500
Product dose omission issue 26.88 18.67 55 4621 154310 42462349
Pulmonary function test decreased 24.03 18.67 12 4664 5720 42610939
Hospitalisation 22.77 18.67 34 4642 74296 42542363
Dry skin 19.11 18.67 25 4651 48313 42568346
Respiratory distress 18.70 18.67 23 4653 41797 42574862

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
Infective pulmonary exacerbation of cystic fibrosis 214.06 15.84 79 14811 14692 110559717
Asthma 207.13 15.84 209 14681 250082 110324327
Dyspnoea 104.49 15.84 356 14534 1106516 109467893
Cough 86.14 15.84 191 14699 461450 110112959
Product dose omission issue 83.77 15.84 153 14737 321629 110252780
Pneumonia 83.42 15.84 283 14607 876431 109697978
Chronic obstructive pulmonary disease 77.28 15.84 84 14806 109074 110465335
Cystic fibrosis 74.83 15.84 27 14863 4704 110569705
Bronchitis 72.11 15.84 97 14793 156935 110417474
Impaired quality of life 65.15 15.84 44 14846 29973 110544436
Coagulation factor deficiency 55.16 15.84 12 14878 320 110574089
Coagulation factor V level abnormal 51.06 15.84 10 14880 156 110574253
Acute respiratory failure 49.94 15.84 56 14834 75204 110499205
Sinusitis 45.68 15.84 114 14776 296574 110277835
Chest discomfort 43.07 15.84 81 14809 173767 110400642
Factor V Leiden mutation 40.00 15.84 9 14881 281 110574128
Hospitalisation 39.88 15.84 70 14820 142423 110431986
Nasal congestion 39.54 15.84 57 14833 98225 110476184
Multiple allergies 39.25 15.84 23 14867 12240 110562169
Toxic optic neuropathy 38.66 15.84 12 14878 1316 110573093
Illness 38.05 15.84 51 14839 82120 110492289
Upper respiratory tract infection 36.08 15.84 64 14826 131264 110443145
Pulmonary function test decreased 35.12 15.84 19 14871 8681 110565728
Device delivery system issue 33.08 15.84 12 14878 2121 110572288
Congenital anomaly 32.73 15.84 10 14880 1041 110573368
General physical health deterioration 31.69 15.84 9 14881 425286 110149123
Headache 29.87 15.84 212 14678 882165 109692244
Creatinine renal clearance decreased 29.37 15.84 24 14866 21791 110552618
Sedation complication 29.19 15.84 23 14867 19832 110554577
Injection site pain 29.09 15.84 70 14820 177852 110396557
Product quality issue 28.45 15.84 43 14847 77256 110497153
Treatment failure 26.80 15.84 3 14887 277231 110297178
Productive cough 25.54 15.84 51 14839 114254 110460155
Influenza 24.97 15.84 64 14826 169037 110405372
Rhinovirus infection 24.91 15.84 17 14873 11772 110562637
COVID-19 24.82 15.84 81 14809 244979 110329430
Infusion site erythema 24.69 15.84 17 14873 11942 110562467
Blood calcium decreased 24.33 15.84 27 14863 35818 110538591
Tracheitis 24.17 15.84 9 14881 1712 110572697
Dermatitis atopic 24.16 15.84 23 14867 25518 110548891
Respiratory distress 23.50 15.84 37 14853 68837 110505572
Viral infection 23.11 15.84 32 14858 53107 110521302
Poor quality device used 22.95 15.84 10 14880 2853 110571556
Bronchopulmonary aspergillosis allergic 22.32 15.84 14 14876 8412 110565997
No adverse event 21.59 15.84 37 14853 73802 110500607
Respiratory tract infection 21.09 15.84 36 14854 71581 110502828
Pseudomonas infection 20.69 15.84 22 14868 27831 110546578
Balance disorder 20.28 15.84 47 14843 116513 110457896
Hepatic enzyme increased 20.13 15.84 9 14881 320883 110253526
Joint swelling 20.13 15.84 18 14872 442827 110131582
Enterovirus infection 20.03 15.84 9 14881 2761 110571648
Postural orthostatic tachycardia syndrome 19.87 15.84 8 14882 1874 110572535
Respiratory syncytial virus infection 19.63 15.84 16 14874 14468 110559941
Insurance issue 19.39 15.84 14 14876 10598 110563811
Renal function test abnormal 19.14 15.84 13 14877 8933 110565476
Drug intolerance 19.11 15.84 16 14874 406496 110167913
Neutropenia 18.54 15.84 14 14876 374606 110199803
Therapeutic product effect decreased 18.50 15.84 5 14885 244311 110330098
Tracheostomy 17.90 15.84 7 14883 1520 110572889
Systemic lupus erythematosus 17.82 15.84 6 14884 254332 110320077
Oropharyngeal pain 17.74 15.84 49 14841 135227 110439182
Pericarditis 17.53 15.84 4 14886 219110 110355299
Wound 17.38 15.84 5 14885 234432 110339977
Rheumatoid arthritis 16.42 15.84 10 14880 299603 110274806
Dry eye 16.37 15.84 28 14862 55765 110518644
Haemoptysis 16.13 15.84 32 14858 71322 110503087

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
FDA MoA N0000009922 Adrenergic beta2-Agonists
FDA EPC N0000175779 beta2-Adrenergic Agonist
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:53784 antispasmodic drug

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Bronchospasm indication 4386001
Acute exacerbation of asthma indication 708038006
Bronchospasm Prevention indication
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Hypokalemia contraindication 43339004
Conduction disorder of the heart contraindication 44808001
Ketoacidosis contraindication 56051008
Diabetes mellitus contraindication 73211009 DOID:9351
Prolonged QT interval contraindication 111975006
Seizure disorder contraindication 128613002
Chronic myocardial ischemia contraindication 413844008 DOID:3393




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.07 acidic
pKa2 9.46 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Beta-2 adrenergic receptor GPCR AGONIST Ki 5.42 CHEMBL CHEMBL
Beta-1 adrenergic receptor GPCR AGONIST EC50 6.20 IUPHAR

External reference:

IDSource
D02281 KEGG_DRUG
50293-90-8 SECONDARY_CAS_RN
661464-94-4 SECONDARY_CAS_RN
4021157 VANDF
C0772501 UMLSCUI
CHEBI:8746 CHEBI
CHEMBL1002 ChEMBL_ID
DB13139 DRUGBANK_ID
CHEMBL1201061 ChEMBL_ID
CHEMBL3989693 ChEMBL_ID
123600 PUBCHEM_CID
9816 IUPHAR_LIGAND_ID
237159 RXNORM
14178 MMSL
167701 MMSL
20402 MMSL
8043 MMSL
d04427 MMSL
007763 NDDF
007764 NDDF
010710 NDDF
116090007 SNOMEDCT_US
398965008 SNOMEDCT_US
412236007 SNOMEDCT_US
426604008 SNOMEDCT_US
D064412 MESH_DESCRIPTOR_UI
68H PDB_CHEM_ID
7681 INN_ID
EDN2NBH5SS UNII
EDN2NBH5SS INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Levalbuterol HUMAN PRESCRIPTION DRUG LABEL 1 0093-4145 SOLUTION 0.31 mg RESPIRATORY (INHALATION) ANDA 27 sections
Levalbuterol HUMAN PRESCRIPTION DRUG LABEL 1 0093-4146 SOLUTION 0.63 mg RESPIRATORY (INHALATION) ANDA 27 sections
Levalbuterol HUMAN PRESCRIPTION DRUG LABEL 1 0093-4148 SOLUTION 1.25 mg RESPIRATORY (INHALATION) ANDA 27 sections
Levalbuterol HUMAN PRESCRIPTION DRUG LABEL 1 0115-9930 SOLUTION 0.31 mg RESPIRATORY (INHALATION) ANDA 31 sections
Levalbuterol HUMAN PRESCRIPTION DRUG LABEL 1 0115-9931 SOLUTION 0.63 mg RESPIRATORY (INHALATION) ANDA 31 sections
Levalbuterol HUMAN PRESCRIPTION DRUG LABEL 1 0115-9932 SOLUTION 1.25 mg RESPIRATORY (INHALATION) ANDA 31 sections
Levalbuterol HUMAN PRESCRIPTION DRUG LABEL 1 0378-6993 SOLUTION, CONCENTRATE 1.25 mg RESPIRATORY (INHALATION) ANDA 27 sections
Levalbuterol HUMAN PRESCRIPTION DRUG LABEL 1 0378-9690 SOLUTION 0.31 mg RESPIRATORY (INHALATION) ANDA 28 sections
Levalbuterol HUMAN PRESCRIPTION DRUG LABEL 1 0378-9691 SOLUTION 0.63 mg RESPIRATORY (INHALATION) ANDA 28 sections
Levalbuterol HUMAN PRESCRIPTION DRUG LABEL 1 0378-9692 SOLUTION 1.25 mg RESPIRATORY (INHALATION) ANDA 28 sections
Levalbuterol tartrate HFA inhalation HUMAN PRESCRIPTION DRUG LABEL 1 0591-2927 AEROSOL, METERED 45 ug ORAL NDA authorized generic 28 sections
Xopenex HUMAN PRESCRIPTION DRUG LABEL 1 17478-171 SOLUTION, CONCENTRATE 1.25 mg RESPIRATORY (INHALATION) NDA 27 sections
Xopenex HUMAN PRESCRIPTION DRUG LABEL 1 17478-172 SOLUTION 0.31 mg RESPIRATORY (INHALATION) NDA 27 sections
Xopenex HUMAN PRESCRIPTION DRUG LABEL 1 17478-173 SOLUTION 0.63 mg RESPIRATORY (INHALATION) NDA 27 sections
Xopenex HUMAN PRESCRIPTION DRUG LABEL 1 17478-174 SOLUTION 1.25 mg RESPIRATORY (INHALATION) NDA 27 sections
Xopenex HUMAN PRESCRIPTION DRUG LABEL 1 21695-153 SOLUTION 1.25 mg RESPIRATORY (INHALATION) NDA 24 sections
XOPENEX HFA HUMAN PRESCRIPTION DRUG LABEL 1 27437-056 AEROSOL, METERED 45 ug ORAL NDA 25 sections
Levalbuterol HUMAN PRESCRIPTION DRUG LABEL 1 35573-443 SOLUTION 0.31 mg RESPIRATORY (INHALATION) ANDA 18 sections
Levalbuterol HUMAN PRESCRIPTION DRUG LABEL 1 35573-444 SOLUTION 0.63 mg RESPIRATORY (INHALATION) ANDA 18 sections
Levalbuterol HUMAN PRESCRIPTION DRUG LABEL 1 35573-445 SOLUTION 1.25 mg RESPIRATORY (INHALATION) ANDA 18 sections
Levalbuterol Inhalation Solution Human Prescription Drug Label 1 47335-743 SOLUTION 0.31 mg RESPIRATORY (INHALATION) ANDA 27 sections
Levalbuterol Inhalation Solution Human Prescription Drug Label 1 47335-746 SOLUTION 0.63 mg RESPIRATORY (INHALATION) ANDA 27 sections
Levalbuterol Inhalation Solution Human Prescription Drug Label 1 47335-753 SOLUTION 1.25 mg RESPIRATORY (INHALATION) ANDA 27 sections
Levalbuterol HUMAN PRESCRIPTION DRUG LABEL 1 50090-6377 SOLUTION 0.63 mg RESPIRATORY (INHALATION) ANDA 18 sections
Xopenex HUMAN PRESCRIPTION DRUG LABEL 1 54868-4409 SOLUTION 0.63 mg RESPIRATORY (INHALATION) NDA 14 sections
Xopenex HUMAN PRESCRIPTION DRUG LABEL 1 54868-5459 SOLUTION 1.25 mg RESPIRATORY (INHALATION) NDA 14 sections
Xopenex HFA HUMAN PRESCRIPTION DRUG LABEL 1 54868-5689 AEROSOL, METERED 45 ug ORAL NDA 24 sections
Xopenex HUMAN PRESCRIPTION DRUG LABEL 1 54868-6021 SOLUTION, CONCENTRATE 1.25 mg RESPIRATORY (INHALATION) NDA 14 sections
Levalbuterol tartrate HFA inhalation HUMAN PRESCRIPTION DRUG LABEL 1 63187-876 AEROSOL, METERED 45 ug ORAL NDA authorized generic 28 sections
Levalbuterol HUMAN PRESCRIPTION DRUG LABEL 1 63187-953 SOLUTION 0.63 mg RESPIRATORY (INHALATION) ANDA 28 sections