levosalbutamol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| bronchodilators, phenethylamine derivatives | 1575 | 34391-04-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
The R-isomer of albuterol.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 25, 1999 | FDA | OAK PHARMS 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 | 190.12 | 14.26 | 179 | 14841 | 89158 | 50500946 |
| Infective pulmonary exacerbation of cystic fibrosis | 136.92 | 14.26 | 60 | 14960 | 7849 | 50582255 |
| Chronic obstructive pulmonary disease | 113.40 | 14.26 | 107 | 14913 | 53328 | 50536776 |
| Pneumonia | 80.87 | 14.26 | 271 | 14749 | 378130 | 50211974 |
| Dyspnoea | 73.04 | 14.26 | 338 | 14682 | 547270 | 50042834 |
| Bronchitis | 68.55 | 14.26 | 116 | 14904 | 104043 | 50486061 |
| Sinusitis | 59.57 | 14.26 | 146 | 14874 | 170412 | 50419692 |
| Wheezing | 59.02 | 14.26 | 82 | 14938 | 61965 | 50528139 |
| Product quality issue | 54.63 | 14.26 | 56 | 14964 | 30802 | 50559302 |
| Cystic fibrosis | 47.21 | 14.26 | 21 | 14999 | 2843 | 50587261 |
| Cough | 47.18 | 14.26 | 168 | 14852 | 241096 | 50349008 |
| Infusion site erythema | 43.66 | 14.26 | 29 | 14991 | 8698 | 50581406 |
| Chest discomfort | 43.11 | 14.26 | 89 | 14931 | 92633 | 50497471 |
| Drug ineffective | 33.48 | 14.26 | 128 | 14892 | 819205 | 49770899 |
| Anaphylactic reaction | 32.64 | 14.26 | 58 | 14962 | 53997 | 50536107 |
| Infusion site swelling | 31.51 | 14.26 | 22 | 14998 | 7154 | 50582950 |
| Maternal exposure during pregnancy | 31.24 | 14.26 | 5 | 15015 | 159773 | 50430331 |
| Respiratory failure | 30.66 | 14.26 | 77 | 14943 | 91104 | 50499000 |
| Rheumatoid arthritis | 30.52 | 14.26 | 11 | 15009 | 202539 | 50387565 |
| Pulmonary function test decreased | 29.29 | 14.26 | 16 | 15004 | 3372 | 50586732 |
| Drug intolerance | 28.11 | 14.26 | 15 | 15005 | 219089 | 50371015 |
| Upper respiratory tract infection | 28 | 14.26 | 61 | 14959 | 65837 | 50524267 |
| Treatment failure | 27.60 | 14.26 | 4 | 15016 | 137633 | 50452471 |
| Anxiety | 26.77 | 14.26 | 114 | 14906 | 177492 | 50412612 |
| Chest pain | 26.25 | 14.26 | 113 | 14907 | 176769 | 50413335 |
| Productive cough | 26.16 | 14.26 | 52 | 14968 | 52642 | 50537462 |
| Joint swelling | 25.79 | 14.26 | 21 | 14999 | 245265 | 50344839 |
| Nasal congestion | 24.84 | 14.26 | 50 | 14970 | 51070 | 50539034 |
| Systemic lupus erythematosus | 24.14 | 14.26 | 6 | 15014 | 140616 | 50449488 |
| Cardiac failure congestive | 24.03 | 14.26 | 67 | 14953 | 84315 | 50505789 |
| Toxicity to various agents | 23.85 | 14.26 | 17 | 15003 | 212482 | 50377622 |
| Headache | 23.82 | 14.26 | 242 | 14778 | 506293 | 50083811 |
| Haemoptysis | 23.11 | 14.26 | 33 | 14987 | 25540 | 50564564 |
| Acute respiratory failure | 22.93 | 14.26 | 35 | 14985 | 28747 | 50561357 |
| Bronchospasm paradoxical | 21.71 | 14.26 | 5 | 15015 | 76 | 50590028 |
| Administration site swelling | 21.61 | 14.26 | 9 | 15011 | 1038 | 50589066 |
| Wound | 21.38 | 14.26 | 3 | 15017 | 105791 | 50484313 |
| Pseudomonas infection | 20.20 | 14.26 | 19 | 15001 | 9411 | 50580693 |
| Respiratory tract infection | 20.16 | 14.26 | 35 | 14985 | 31982 | 50558122 |
| Respiratory distress | 20.08 | 14.26 | 34 | 14986 | 30455 | 50559649 |
| Alopecia | 20.06 | 14.26 | 26 | 14994 | 245021 | 50345083 |
| Product dose omission issue | 19.72 | 14.26 | 107 | 14913 | 183731 | 50406373 |
| Poor quality device used | 19.57 | 14.26 | 10 | 15010 | 1841 | 50588263 |
| Bronchospasm | 19.41 | 14.26 | 23 | 14997 | 14831 | 50575273 |
| Infusion site pain | 19.34 | 14.26 | 21 | 14999 | 12325 | 50577779 |
| Infusion site extravasation | 18.79 | 14.26 | 16 | 15004 | 6960 | 50583144 |
| Ear infection | 18.49 | 14.26 | 30 | 14990 | 25940 | 50564164 |
| Heart rate increased | 17.88 | 14.26 | 57 | 14963 | 77193 | 50512911 |
| Dysphonia | 17.66 | 14.26 | 37 | 14983 | 38855 | 50551249 |
| Infusion related reaction | 17.21 | 14.26 | 15 | 15005 | 169542 | 50420562 |
| Tracheitis | 17.06 | 14.26 | 7 | 15013 | 777 | 50589327 |
| Hepatic enzyme increased | 16.75 | 14.26 | 10 | 15010 | 137370 | 50452734 |
| Viral infection | 16.60 | 14.26 | 31 | 14989 | 29955 | 50560149 |
| Rhinitis allergic | 16.37 | 14.26 | 15 | 15005 | 7185 | 50582919 |
| Discomfort | 16.12 | 14.26 | 6 | 15014 | 108374 | 50481730 |
| Migraine | 16.03 | 14.26 | 54 | 14966 | 75226 | 50514878 |
| Pulmonary embolism | 15.86 | 14.26 | 66 | 14954 | 101638 | 50488466 |
| Bronchitis chronic | 14.99 | 14.26 | 11 | 15009 | 3866 | 50586238 |
| Off label use | 14.59 | 14.26 | 82 | 14938 | 474344 | 50115760 |
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 |
|---|---|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | 105.17 | 17.98 | 41 | 5643 | 6195 | 29562648 |
| Asthma | 75.63 | 17.98 | 58 | 5626 | 33791 | 29535052 |
| Dyspnoea | 50.46 | 17.98 | 157 | 5527 | 326575 | 29242268 |
| Chronic obstructive pulmonary disease | 48.62 | 17.98 | 49 | 5635 | 40906 | 29527937 |
| Pneumonia | 39.71 | 17.98 | 143 | 5541 | 320029 | 29248814 |
| Respiratory distress | 35.53 | 17.98 | 37 | 5647 | 32069 | 29536774 |
| Cough | 35.08 | 17.98 | 76 | 5608 | 126651 | 29442192 |
| Upper respiratory tract infection | 32.95 | 17.98 | 33 | 5651 | 27316 | 29541527 |
| Toxic optic neuropathy | 32.67 | 17.98 | 10 | 5674 | 731 | 29568112 |
| Sinusitis | 28.40 | 17.98 | 34 | 5650 | 34316 | 29534527 |
| Status asthmaticus | 26.84 | 17.98 | 7 | 5677 | 285 | 29568558 |
| Cystic fibrosis | 22.31 | 17.98 | 9 | 5675 | 1483 | 29567360 |
| Pulmonary function test decreased | 21.31 | 17.98 | 12 | 5672 | 4151 | 29564692 |
| Respiratory failure | 21.08 | 17.98 | 53 | 5631 | 97078 | 29471765 |
| Product quality issue | 20.66 | 17.98 | 20 | 5664 | 15875 | 29552968 |
| Bronchospasm paradoxical | 19.28 | 17.98 | 4 | 5680 | 58 | 29568785 |
| Toxicity to various agents | 18.96 | 17.98 | 5 | 5679 | 173656 | 29395187 |
FDA Adverse Event Reporting System (Geriatric)
| 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 |
|---|---|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | 186.89 | 14.33 | 78 | 14755 | 11718 | 64472181 |
| Asthma | 138.39 | 14.33 | 138 | 14695 | 95087 | 64388812 |
| Chronic obstructive pulmonary disease | 122.18 | 14.33 | 113 | 14720 | 70935 | 64412964 |
| Dyspnoea | 90.82 | 14.33 | 365 | 14468 | 718309 | 63765590 |
| Product quality issue | 66.48 | 14.33 | 55 | 14778 | 29744 | 64454155 |
| Cystic fibrosis | 65.66 | 14.33 | 26 | 14807 | 3408 | 64480491 |
| Pneumonia | 64.79 | 14.33 | 277 | 14556 | 559299 | 63924600 |
| Cough | 58.38 | 14.33 | 177 | 14656 | 301971 | 64181928 |
| Bronchitis | 51.70 | 14.33 | 91 | 14742 | 108652 | 64375247 |
| Wheezing | 48.49 | 14.33 | 75 | 14758 | 80504 | 64403395 |
| Respiratory distress | 45.32 | 14.33 | 58 | 14775 | 52273 | 64431626 |
| Toxicity to various agents | 41.30 | 14.33 | 16 | 14817 | 363497 | 64120402 |
| Pulmonary function test decreased | 36.12 | 14.33 | 21 | 14812 | 6440 | 64477459 |
| Acute respiratory failure | 35.09 | 14.33 | 50 | 14783 | 49884 | 64434015 |
| Chest discomfort | 32.41 | 14.33 | 78 | 14755 | 116028 | 64367871 |
| Toxic optic neuropathy | 32.37 | 14.33 | 11 | 14822 | 936 | 64482963 |
| Respiratory failure | 31.59 | 14.33 | 95 | 14738 | 161088 | 64322811 |
| Bronchospasm paradoxical | 30.27 | 14.33 | 7 | 14826 | 142 | 64483757 |
| Status asthmaticus | 28.28 | 14.33 | 10 | 14823 | 958 | 64482941 |
| Infusion site erythema | 27.38 | 14.33 | 18 | 14815 | 6855 | 64477044 |
| Bronchospasm | 27.06 | 14.33 | 29 | 14804 | 21653 | 64462246 |
| Respiratory syncytial virus infection | 26.46 | 14.33 | 18 | 14815 | 7250 | 64476649 |
| Product dose omission issue | 26.03 | 14.33 | 101 | 14732 | 194646 | 64289253 |
| Nasal congestion | 25.87 | 14.33 | 48 | 14785 | 59610 | 64424289 |
| Tracheitis | 25.48 | 14.33 | 10 | 14823 | 1280 | 64482619 |
| Chest pain | 22.81 | 14.33 | 111 | 14722 | 235869 | 64248030 |
| Headache | 22.75 | 14.33 | 203 | 14630 | 529264 | 63954635 |
| Upper respiratory tract infection | 22.60 | 14.33 | 51 | 14782 | 72734 | 64411165 |
| Poor quality device used | 21.22 | 14.33 | 10 | 14823 | 1997 | 64481902 |
| Sinusitis | 20.57 | 14.33 | 77 | 14756 | 145851 | 64338048 |
| Pulmonary hypertension | 20.34 | 14.33 | 36 | 14797 | 43103 | 64440796 |
| Drug interaction | 19.81 | 14.33 | 33 | 14800 | 362050 | 64121849 |
| Anxiety | 19.34 | 14.33 | 95 | 14738 | 202554 | 64281345 |
| Infusion site swelling | 18.63 | 14.33 | 13 | 14820 | 5452 | 64478447 |
| Hypoxia | 18.24 | 14.33 | 53 | 14780 | 88096 | 64395803 |
| Heart rate increased | 18.23 | 14.33 | 57 | 14776 | 98618 | 64385281 |
| Viral infection | 18.14 | 14.33 | 31 | 14802 | 36109 | 64447790 |
| Enterovirus infection | 17.72 | 14.33 | 8 | 14825 | 1449 | 64482450 |
| Rheumatoid arthritis | 17.39 | 14.33 | 8 | 14825 | 164286 | 64319613 |
| Pseudomonas infection | 17.36 | 14.33 | 21 | 14812 | 17862 | 64466037 |
| Hospitalisation | 17.31 | 14.33 | 47 | 14786 | 75160 | 64408739 |
| Haemoptysis | 17.08 | 14.33 | 36 | 14797 | 49012 | 64434887 |
| Anhedonia | 16.52 | 14.33 | 18 | 14815 | 13688 | 64470211 |
| Off label use | 16.05 | 14.33 | 83 | 14750 | 632723 | 63851176 |
| Carbon dioxide increased | 15.35 | 14.33 | 8 | 14825 | 1981 | 64481918 |
| Dysphonia | 14.95 | 14.33 | 33 | 14800 | 46349 | 64437550 |
| Supraventricular tachycardia | 14.88 | 14.33 | 20 | 14813 | 18887 | 64465012 |
| Therapeutic product effect incomplete | 14.60 | 14.33 | 3 | 14830 | 103479 | 64380420 |
| Joint swelling | 14.39 | 14.33 | 17 | 14816 | 215365 | 64268534 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| FDA MoA | N0000009922 | Adrenergic beta2-Agonists |
| FDA EPC | N0000175779 | beta2-Adrenergic Agonist |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 10.07 | acidic |
| pKa2 | 9.46 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 0.045MG BASE/INH | XOPENEX HFA | SUNOVION | N021730 | March 11, 2005 | RX | AEROSOL, METERED | INHALATION | 7256310 | Oct. 8, 2024 | TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Beta-2 adrenergic receptor | GPCR | AGONIST | Ki | 5.42 | CHEMBL | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D02281 | KEGG_DRUG |
| 50293-90-8 | SECONDARY_CAS_RN |
| 661464-94-4 | SECONDARY_CAS_RN |
| 4021157 | VANDF |
| C0772501 | UMLSCUI |
| CHEBI:8746 | CHEBI |
| 68H | PDB_CHEM_ID |
| 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 |
| 7681 | INN_ID |
| EDN2NBH5SS | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 | 0093-4147 | SOLUTION, CONCENTRATE | 1.25 mg | RESPIRATORY (INHALATION) | ANDA | 26 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 | 27 sections |
| Levalbuterol Inhalation Solution | Human Prescription Drug Label | 1 | 16714-094 | SOLUTION | 0.31 mg | RESPIRATORY (INHALATION) | ANDA | 27 sections |
| Levalbuterol Inhalation Solution | Human Prescription Drug Label | 1 | 16714-095 | SOLUTION | 0.63 mg | RESPIRATORY (INHALATION) | ANDA | 27 sections |
| Levalbuterol Inhalation Solution | Human Prescription Drug Label | 1 | 16714-096 | SOLUTION | 1.25 mg | RESPIRATORY (INHALATION) | ANDA | 27 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 |
| 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 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-409 | SOLUTION | 1.25 mg | RESPIRATORY (INHALATION) | ANDA | 27 sections |
| levalbuterol inhalation | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-410 | SOLUTION | 0.63 mg | RESPIRATORY (INHALATION) | ANDA | 27 sections |
| levalbuterol inhalation | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-412 | SOLUTION | 0.31 mg | RESPIRATORY (INHALATION) | ANDA | 27 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 |
| Xopenex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-4409 | SOLUTION | 0.63 mg | RESPIRATORY (INHALATION) | NDA | 14 sections |