beclometasone dipropionate Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
prednisone and prednisolone derivatives 294 5534-09-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • rhinocort
  • beclometasone dipropionate
  • beclomethasone dipropionate
  • beclomethasone dipropionate monohydrate
An anti-inflammatory, synthetic glucocorticoid. It is used topically as an anti-inflammatory agent and in aerosol form for the treatment of ASTHMA.
  • Molecular weight: 521.05
  • Formula: C28H37ClO7
  • CLOGP: 4.26
  • LIPINSKI: 1
  • HAC: 7
  • HDO: 1
  • TPSA: 106.97
  • ALOGS: -5.40
  • ROTB: 8

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.40 mg N
0.80 mg Inhal.aerosol
0.80 mg Inhal.powder
1.50 mg Inhal.solution

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.05 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.29 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 36 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.13 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.50 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
May 12, 1976 FDA

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 503.25 11.33 402 24056 91140 46570464
Wheezing 185.45 11.33 181 24277 53205 46608399
Dyspnoea 87.42 11.33 513 23945 515035 46146569
Rheumatoid arthritis 75.06 11.33 17 24441 240198 46421406
Death 64.52 11.33 49 24409 335499 46326105
Lip swelling 59.60 11.33 70 24388 25325 46636279
Cough 59.17 11.33 258 24200 229991 46431613
Toxicity to various agents 56.85 11.33 20 24438 211746 46449858
Swelling face 54.65 11.33 99 24359 52960 46608644
Asthmatic crisis 52.41 11.33 22 24436 1456 46660148
Swollen tongue 51.76 11.33 70 24388 29162 46632442
Chest discomfort 49.91 11.33 131 24327 90138 46571466
Drug ineffective 48.77 11.33 187 24271 677651 45983953
Depressed mood 44.73 11.33 70 24388 33249 46628355
Periorbital swelling 41.66 11.33 18 24440 1280 46660324
Bronchospasm 41.43 11.33 46 24412 15661 46645943
Anaphylactic reaction 40.08 11.33 87 24371 53025 46608579
Flashback 39.74 11.33 10 24448 123 46661481
Blood electrolytes abnormal 39.25 11.33 16 24442 983 46660621
Eosinophilic granulomatosis with polyangiitis 38.65 11.33 19 24439 1817 46659787
Sinusitis 38.43 11.33 152 24306 129616 46531988
Nightmare 37.70 11.33 45 24413 16553 46645051
Sputum discoloured 34.70 11.33 38 24420 12740 46648864
Malaise 34.31 11.33 293 24165 330939 46330665
Productive cough 33.71 11.33 79 24379 50636 46610968
Paraesthesia oral 33.70 11.33 36 24422 11737 46649867
Obstructive airways disorder 33.19 11.33 38 24420 13374 46648230
Alkalosis hypochloraemic 33.12 11.33 9 24449 152 46661452
Throat tightness 32.90 11.33 47 24411 20592 46641012
Squamous cell carcinoma of the oral cavity 31.30 11.33 10 24448 302 46661302
Treatment failure 30.23 11.33 6 24452 93081 46568523
Off label use 29.02 11.33 102 24356 379739 46281865
Middle insomnia 28.84 11.33 30 24428 9485 46652119
Drug monitoring procedure not performed 28.84 11.33 10 24448 391 46661213
Miller Fisher syndrome 26.78 11.33 7 24451 101 46661503
Contraindicated product administered 26.28 11.33 5 24453 79942 46581662
Hyponatraemia 25.53 11.33 113 24345 101219 46560385
Bronchitis 25.07 11.33 116 24342 105863 46555741
Arterial spasm 24.13 11.33 6 24452 70 46661534
Differential white blood cell count abnormal 23.92 11.33 10 24448 655 46660949
Nasal discomfort 23.89 11.33 18 24440 3720 46657884
Transient ischaemic attack 23.88 11.33 55 24403 34848 46626756
Rash macular 23.84 11.33 39 24419 19221 46642383
Dysmetropsia 23.75 11.33 6 24452 75 46661529
Status asthmaticus 23.71 11.33 11 24447 925 46660679
Forced expiratory volume decreased 22.92 11.33 20 24438 5084 46656520
Urticaria 22.89 11.33 122 24336 117770 46543834
Limb injury 22.62 11.33 38 24420 19136 46642468
Synovitis 21.91 11.33 3 24455 61072 46600532
Idiopathic orbital inflammation 21.08 11.33 6 24452 121 46661483
Infective pulmonary exacerbation of cystic fibrosis 20.85 11.33 27 24431 10780 46650824
Eye movement disorder 19.97 11.33 18 24440 4775 46656829
Aspirin-exacerbated respiratory disease 19.60 11.33 9 24449 739 46660865
Systemic lupus erythematosus 19.56 11.33 5 24453 65175 46596429
Intentional overdose 19.45 11.33 5 24453 64939 46596665
Malignant neoplasm progression 19.44 11.33 5 24453 64921 46596683
Anxiety 19.33 11.33 162 24296 181795 46479809
Breast conserving surgery 19.12 11.33 9 24449 782 46660822
Gingival swelling 18.80 11.33 16 24442 3934 46657670
Pharyngeal swelling 18.74 11.33 15 24443 3388 46658216
Contusion 18.69 11.33 93 24365 87394 46574210
Skin fragility 18.35 11.33 8 24450 581 46661023
Pregnancy with implant contraceptive 18.24 11.33 12 24446 2000 46659604
Throat irritation 18.10 11.33 44 24414 28857 46632747
Infusion related reaction 17.88 11.33 16 24442 101192 46560412
Bronchial secretion retention 17.62 11.33 9 24449 934 46660670
Palpitations 17.42 11.33 97 24361 95162 46566442
Drug abuse 16.97 11.33 6 24452 63402 46598202
Dizziness 16.88 11.33 261 24197 340153 46321451
Nonspecific reaction 16.69 11.33 11 24447 1839 46659765
Retinopathy proliferative 16.56 11.33 4 24454 41 46661563
Bacterial disease carrier 16.52 11.33 8 24450 740 46660864
Tendonitis 16.45 11.33 28 24430 14249 46647355
Sleep disorder due to a general medical condition 16.30 11.33 14 24444 3485 46658119
Facial pain 16.22 11.33 20 24438 7605 46653999
Anaemia 16.13 11.33 74 24384 255705 46405899
Derealisation 15.98 11.33 8 24450 795 46660809
Rhinovirus infection 15.83 11.33 14 24444 3622 46657982
Aggression 15.73 11.33 36 24422 22708 46638896
Brain contusion 15.55 11.33 7 24451 549 46661055
Myalgia 15.49 11.33 114 24344 122974 46538630
Bladder irritation 15.29 11.33 5 24453 163 46661441
Nasal septum ulceration 15.27 11.33 3 24455 10 46661594
Gastric mucosa erythema 14.92 11.33 5 24453 176 46661428
Peripheral vascular disorder 14.90 11.33 17 24441 5960 46655644
Blood creatinine increased 14.84 11.33 11 24447 76392 46585212
Choking 14.73 11.33 20 24438 8356 46653248
Arthropathy 14.24 11.33 14 24444 84686 46576918
Cytomegalovirus enteritis 14.24 11.33 5 24453 203 46661401
Plasma cell myeloma 14.16 11.33 3 24455 44475 46617129
Platelet count decreased 14.15 11.33 19 24439 100005 46561599
Lip infection 14.04 11.33 4 24454 81 46661523
Oral mucosa erosion 13.69 11.33 8 24450 1082 46660522
Drug intolerance 13.68 11.33 36 24422 147013 46514591
Pruritus 13.64 11.33 190 24268 242162 46419442
Tongue pruritus 13.57 11.33 6 24452 451 46661153
Nasal septum perforation 13.48 11.33 7 24451 752 46660852
Febrile neutropenia 13.36 11.33 18 24440 94609 46566995
Antipsychotic drug level increased 13.32 11.33 12 24446 3180 46658424
Secretion discharge 13.25 11.33 20 24438 9199 46652405
Angioedema 13.21 11.33 48 24410 39294 46622310
Nasal congestion 13.14 11.33 55 24403 48058 46613546
Product administered to patient of inappropriate age 12.99 11.33 11 24447 2685 46658919
Gastroenteritis aeromonas 12.98 11.33 3 24455 25 46661579
Drug hypersensitivity 12.86 11.33 75 24383 243750 46417854
Necrosis ischaemic 12.77 11.33 7 24451 838 46660766
Mobility decreased 12.73 11.33 8 24450 60586 46601018
Nasal polyps 12.72 11.33 10 24448 2200 46659404
Enlarged uvula 12.68 11.33 4 24454 116 46661488
Rhinorrhoea 12.64 11.33 54 24404 47611 46613993
Dermatitis allergic 12.31 11.33 23 24435 12580 46649024
Dysphonia 12.17 11.33 46 24412 38368 46623236
Upper gastrointestinal haemorrhage 12.14 11.33 27 24431 16711 46644893
Sneezing 12.14 11.33 23 24435 12718 46648886
Headache 12.12 11.33 332 24126 478020 46183584
Subretinal haematoma 11.99 11.33 3 24455 36 46661568
Intraocular haematoma 11.99 11.33 3 24455 36 46661568
Migraine 11.94 11.33 70 24388 69956 46591648
Viral haemorrhagic cystitis 11.89 11.33 6 24452 607 46660997
Pericarditis constrictive 11.74 11.33 5 24453 343 46661261
Intentional product misuse 11.71 11.33 5 24453 47123 46614481
Post abortion haemorrhage 11.63 11.33 3 24455 41 46661563
Nasal discharge discolouration 11.61 11.33 8 24450 1440 46660164
Respiratory rate increased 11.34 11.33 21 24437 11412 46650192

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
Asthma 336.41 12.37 217 15152 35957 29901152
Wheezing 134.92 12.37 118 15251 30820 29906289
Dyspnoea 86.30 12.37 368 15001 332927 29604182
Ballismus 57.78 12.37 12 15357 58 29937051
Anger 53.69 12.37 45 15324 11075 29926034
Lip swelling 52.29 12.37 47 15322 12697 29924412
Nightmare 50.47 12.37 45 15324 12031 29925078
Swollen tongue 48.97 12.37 46 15323 13146 29923963
Sleep terror 44.18 12.37 16 15353 727 29936382
Pharyngeal oedema 41.60 12.37 31 15338 6440 29930669
Blood immunoglobulin E increased 40.11 12.37 19 15350 1711 29935398
Lower respiratory tract infection 38 12.37 57 15312 26657 29910452
Anosmia 36.61 12.37 19 15350 2081 29935028
Cough 34.00 12.37 141 15228 125501 29811608
Nasal disorder 33.87 12.37 15 15354 1156 29935953
Nasal discomfort 33.39 12.37 15 15354 1196 29935913
Death 33.31 12.37 85 15284 357198 29579911
Attention-seeking behaviour 32.87 12.37 7 15362 39 29937070
Hyperkaliuria 32.71 12.37 9 15360 163 29936946
Infective pulmonary exacerbation of cystic fibrosis 32.02 12.37 30 15339 8542 29928567
Toxicity to various agents 31.27 12.37 27 15342 177156 29759953
Acquired macroglossia 31.15 12.37 6 15363 18 29937091
Malaise 31.03 12.37 168 15201 166794 29770315
Chronic obstructive pulmonary disease 28.56 12.37 69 15300 46057 29891052
Completed suicide 28.28 12.37 8 15361 99484 29837625
Dyspnoea at rest 27.57 12.37 17 15352 2589 29934520
Chorea 25.35 12.37 12 15357 1079 29936030
Crepitations 25.26 12.37 17 15352 3007 29934102
Chest discomfort 24.98 12.37 65 15304 45415 29891694
Drug abuse 24.46 12.37 6 15363 82066 29855043
Sputum discoloured 24.26 12.37 23 15346 6645 29930464
Daydreaming 23.82 12.37 9 15360 461 29936648
Neuropsychiatric symptoms 23.30 12.37 9 15360 490 29936619
Neonatal hyponatraemia 22.93 12.37 6 15363 89 29937020
Central obesity 22.32 12.37 9 15360 549 29936560
Productive cough 22.07 12.37 48 15321 29905 29907204
Crying 21.66 12.37 20 15349 5589 29931520
Gastric ulcer perforation 21.37 12.37 10 15359 876 29936233
Gastrointestinal tract irritation 21.32 12.37 7 15362 236 29936873
Abnormal behaviour 21.13 12.37 43 15326 25580 29911529
Palpitations 20.54 12.37 50 15319 33523 29903586
Inflammatory myofibroblastic tumour 20.54 12.37 6 15363 136 29936973
Suicidal ideation 20.22 12.37 52 15317 36062 29901047
Malignant neoplasm progression 20.19 12.37 6 15363 72281 29864828
Cervicogenic headache 20.08 12.37 4 15365 15 29937094
Obstructive airways disorder 20.06 12.37 24 15345 9035 29928074
Micturition urgency 19.56 12.37 17 15352 4390 29932719
Urticaria 19.48 12.37 67 15302 54539 29882570
Angioedema 18.73 12.37 49 15320 34335 29902774
Spleen congestion 18.33 12.37 7 15362 369 29936740
Paraesthesia oral 18.05 12.37 15 15354 3646 29933463
Renal failure 17.89 12.37 24 15345 128942 29808167
Dizziness 17.76 12.37 165 15204 194744 29742365
Platelet count decreased 17.71 12.37 17 15352 106112 29830997
Product monitoring error 17.51 12.37 11 15358 1730 29935379
Neuropsychiatric syndrome 17.48 12.37 5 15364 105 29937004
Hypoproteinaemia 17.09 12.37 11 15358 1805 29935304
Ageusia 17.06 12.37 22 15347 8931 29928178
Eye swelling 17.04 12.37 22 15347 8942 29928167
Nasal septum perforation 16.89 12.37 5 15364 119 29936990
Locked-in syndrome 16.79 12.37 6 15363 262 29936847
Mesothelioma 16.79 12.37 7 15362 465 29936644
Neutropenia 16.76 12.37 25 15344 128515 29808594
Blood count abnormal 16.76 12.37 25 15344 11627 29925482
Neonatal seizure 16.68 12.37 7 15362 473 29936636
Ejaculation failure 16.19 12.37 8 15361 790 29936319
Convulsive threshold lowered 16.02 12.37 7 15362 522 29936587
Multifocal motor neuropathy 15.85 12.37 4 15365 51 29937058
Self-injurious ideation 15.77 12.37 10 15359 1599 29935510
Depressed mood 15.76 12.37 30 15339 16999 29920110
Thrombocytopenia 15.69 12.37 29 15340 137015 29800094
Eosinophilic pneumonia chronic 15.37 12.37 4 15365 58 29937051
Anaphylactic reaction 15.36 12.37 40 15329 27942 29909167
Rhinitis 15.22 12.37 15 15354 4544 29932565
Ocular discomfort 14.87 12.37 9 15360 1326 29935783
Lower respiratory tract congestion 14.39 12.37 8 15361 1005 29936104
Renal aplasia 14.36 12.37 7 15362 671 29936438
Disease progression 14.27 12.37 12 15357 79862 29857247
Aortic dissection 14.15 12.37 11 15358 2431 29934678
Graft versus host disease in gastrointestinal tract 13.95 12.37 12 15357 3057 29934052
Plasma cell myeloma 13.94 12.37 5 15364 53457 29883652
Tryptase increased 13.94 12.37 5 15364 221 29936888
Product administered to patient of inappropriate age 13.76 12.37 11 15358 2532 29934577
Nasal inflammation 13.66 12.37 5 15364 234 29936875
Leukopenia 13.42 12.37 6 15363 56153 29880956
Mood swings 13.39 12.37 18 15351 7608 29929501
Weaning failure 13.22 12.37 5 15364 257 29936852
Bronchospasm 13.21 12.37 21 15348 10317 29926792
Rash papular 13.08 12.37 19 15350 8626 29928483
Cryptorchism 12.99 12.37 9 15360 1668 29935441
Sinusitis 12.85 12.37 42 15327 33303 29903806
Nasal congestion 12.82 12.37 29 15340 18537 29918572
Apnoeic attack 12.74 12.37 5 15364 284 29936825
Febrile neutropenia 12.72 12.37 22 15347 106671 29830438
Violence-related symptom 12.66 12.37 6 15363 541 29936568
Tendonitis 12.66 12.37 18 15351 8018 29929091
Cystic fibrosis 12.65 12.37 10 15359 2264 29934845
Pain 12.50 12.37 46 15323 172595 29764514
Eosinophilia 12.50 12.37 32 15337 22128 29914981

Pharmacologic Action:

SourceCodeDescription
ATC A07EA07 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
INTESTINAL ANTIINFLAMMATORY AGENTS
Corticosteroids acting locally
ATC D07AC15 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, potent (group III)
ATC D07CC04 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS
Corticosteroids, potent, combinations with antibiotics
ATC R01AD01 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R03AK08 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK13 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AL09 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03BA01 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Glucocorticoids
CHEBI has role CHEBI:35472 anti-inflammatory drugs
CHEBI has role CHEBI:49167 anti-asthmatic agents
CHEBI has role CHEBI:38070 antiarrhythmic agent
CHEBI has role CHEBI:50266 prodrugs
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D005938 Glucocorticoids
MeSH PA D006728 Hormones
MeSH PA D019141 Respiratory System Agents
MeSH PA D001993 Bronchodilator Agents
MeSH PA D018373 Peripheral Nervous System Agents
FDA EPC N0000175576 Corticosteroid
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Vasomotor rhinitis indication 8229003 DOID:4730
Nasal polyp indication 52756005
Allergic rhinitis indication 61582004
Rhinitis indication 70076002 DOID:4483
Asthma indication 195967001 DOID:2841
Asthma management indication 406162001
Severe chronic obstructive pulmonary disease off-label use 313299006
Mycosis contraindication 3218000 DOID:1564
Ocular hypertension contraindication 4210003 DOID:9282
Inactive tuberculosis contraindication 11999007
Epistaxis contraindication 12441001
Measles contraindication 14189004 DOID:8622
Disease caused by parasite contraindication 17322007
Glaucoma contraindication 23986001 DOID:1686
Acute tuberculosis contraindication 25629007
Perforation of nasal septum contraindication 80142000
Bacterial infectious disease contraindication 87628006
Mycobacteriosis contraindication 88415009
Operation on nose contraindication 88733004
Bilateral cataracts contraindication 95722004
Ophthalmic herpes simplex contraindication 186542001
Disease of liver contraindication 235856003 DOID:409
Varicella-zoster virus infection contraindication 309465005
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Exposure to varicella contraindication 444453009
Nasal Trauma contraindication
Nasal Candidiasis contraindication
Nasal Septal Ulcers contraindication
Uncontrolled Bacterial Infections contraindication
Untreated Fungal Infection contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.01 acidic

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
Glucocorticoid receptor Nuclear hormone receptor AGONIST Ki 8.43 DRUG MATRIX CHEMBL
Matrix metalloproteinase-9 Enzyme IC50 5.70 CHEMBL
Interleukin-5 Cytokine IC50 4.57 CHEMBL
Glucocorticoid receptor Transcription factor IC50 8.54 CHEMBL
Interleukin-5 Unclassified IC50 4.58 CHEMBL
Progesterone receptor Transcription factor Ki 7.57 CHEMBL
Androgen receptor Transcription factor Ki 5.96 CHEMBL

External reference:

IDSource
5B307S63B2 UNII
D00689 KEGG_DRUG
77011-63-3 SECONDARY_CAS_RN
4419-39-0 SECONDARY_CAS_RN
4018793 VANDF
4019625 VANDF
C0004906 UMLSCUI
C0004905 UMLSCUI
CHEBI:3002 CHEBI
CHEBI:3001 CHEBI
CHEMBL1200500 ChEMBL_ID
DB00394 DRUGBANK_ID
CHEMBL1370 ChEMBL_ID
CHEMBL1586 ChEMBL_ID
D001507 MESH_DESCRIPTOR_UI
D019819 MESH_DESCRIPTOR_UI
21700 PUBCHEM_CID
5894 IUPHAR_LIGAND_ID
2307 INN_ID
KGZ1SLC28Z UNII
20469 PUBCHEM_CID
7059 IUPHAR_LIGAND_ID
1347 RXNORM
1167 MMSL
4249 MMSL
71834 MMSL
8263 MMSL
d00760 MMSL
002179 NDDF
004947 NDDF
116574000 SNOMEDCT_US
116575004 SNOMEDCT_US
1389007 SNOMEDCT_US
426017007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
BECONULLSEAQ HUMAN PRESCRIPTION DRUG LABEL 1 0173-0388 SPRAY, SUSPENSION 42 ug NULLSAL NDA 20 sections
BECONULLSE AQ HUMAN PRESCRIPTION DRUG LABEL 1 16590-030 SPRAY, SUSPENSION 42 ug NULLSAL NDA 13 sections
QVAR HUMAN PRESCRIPTION DRUG LABEL 1 16590-860 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 26 sections
QVAR HUMAN PRESCRIPTION DRUG LABEL 1 50090-1342 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 28 sections
QVAR HUMAN PRESCRIPTION DRUG LABEL 1 50090-3033 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 28 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 50090-3459 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 16 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 50090-5031 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 50090-5032 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 53002-2436 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 16 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 53002-3477 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 16 sections
QVAR HUMAN PRESCRIPTION DRUG LABEL 1 54868-5857 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 14 sections
QVAR HUMAN PRESCRIPTION DRUG LABEL 1 54868-5858 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 14 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 59310-302 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 59310-304 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 17 sections
QNULLSL HUMAN PRESCRIPTION DRUG LABEL 1 59310-406 AEROSOL, METERED 40 ug NULLSAL NDA 27 sections
QNULLSL HUMAN PRESCRIPTION DRUG LABEL 1 59310-410 AEROSOL, METERED 80 ug NULLSAL NDA 27 sections