budesonide Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
steroids for topical use, acetal derivatives 419 51333-22-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • budesonide
  • barazone
  • budesomide
  • budeson
A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.
  • Molecular weight: 430.54
  • Formula: C25H34O6
  • CLOGP: 2.90
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 93.06
  • ALOGS: -3.97
  • ROTB: 4

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
9 mg O
0.20 mg N
0.80 mg Inhal.aerosol
0.80 mg Inhal.powder
1.50 mg Inhal.solution

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.02 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.04 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 37 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 3.90 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 20 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) 2.80 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Feb. 14, 1994 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 1968.53 27.23 456 3173 10858 2343598
Dyspnoea 1200.62 27.23 486 3143 78247 2276209
Wheezing 622.82 27.23 163 3466 6221 2348235
Cough 530.12 27.23 214 3415 32903 2321553
Obstructive airways disorder 520.90 27.23 106 3523 1267 2353189
Drug ineffective 466.27 27.23 279 3350 101345 2253111
Blood count abnormal 456.41 27.23 104 3525 2178 2352278
Chronic obstructive pulmonary disease 453.73 27.23 130 3499 6947 2347509
Intentional product misuse 407.70 27.23 128 3501 9361 2345095
Chest discomfort 338.68 27.23 124 3505 14471 2339985
Therapeutic product effect incomplete 310.72 27.23 107 3522 10424 2344032
Off label use 309.75 27.23 192 3437 73406 2281050
Pneumonia 257.25 27.23 148 3481 49148 2305308
Productive cough 216.54 27.23 69 3560 5252 2349204
Condition aggravated 210.34 27.23 112 3517 31867 2322589
Product dose omission 207.64 27.23 118 3511 38139 2316317
Cushing's syndrome 207.17 27.23 45 3584 744 2353712
Device malfunction 190.38 27.23 56 3573 3251 2351205
Intentional device misuse 186.35 27.23 32 3597 133 2354323
Circumstance or information capable of leading to medication error 172.20 27.23 41 3588 1037 2353419
Product use in unapproved indication 169.81 27.23 70 3559 11130 2343326
Dysphonia 169.46 27.23 60 3569 6304 2348152
Palpitations 156.15 27.23 74 3555 16382 2338074
Malaise 137.57 27.23 105 3524 55480 2298976
Tremor 137.35 27.23 73 3556 20588 2333868
Gastrooesophageal reflux disease 134.94 27.23 56 3573 9039 2345417
Feeling jittery 134.72 27.23 38 3591 1894 2352562
Hypertension 131.16 27.23 78 3551 27283 2327173
Device failure 128.91 27.23 36 3593 1729 2352727
Reversible airways obstruction 120.85 27.23 18 3611 20 2354436
Maternal exposure during pregnancy 120.35 27.23 60 3569 14803 2339653
Candida infection 115.71 27.23 37 3592 2836 2351620
Chest pain 113.84 27.23 72 3557 28065 2326391
Rash 112.26 27.23 96 3533 59462 2294994
Weight increased 107.81 27.23 64 3565 22273 2332183
Product use issue 107.06 27.23 52 3577 12117 2342339
Eosinophil count increased 105.54 27.23 28 3601 1106 2353350
Foetal exposure during pregnancy 104.54 27.23 40 3589 5212 2349244
Dyspnoea exertional 101.23 27.23 40 3589 5680 2348776
Swelling face 100.19 27.23 46 3583 9447 2345009
Drug hypersensitivity 99.88 27.23 81 3548 46562 2307894
Product quality issue 97.43 27.23 47 3582 10782 2343674
Sputum discoloured 90.72 27.23 25 3604 1141 2353315
Nasal congestion 90.31 27.23 39 3590 6927 2347529
Hypersensitivity 89.48 27.23 58 3571 23535 2330921
Anxiety 89.45 27.23 63 3566 29296 2325160
Exposure during pregnancy 85.96 27.23 58 3571 25161 2329295
Respiratory disorder 85.10 27.23 32 3597 3972 2350484
Throat irritation 84.90 27.23 34 3595 4996 2349460
Nausea 84.76 27.23 111 3518 112078 2242378
Dizziness 83.80 27.23 81 3548 58584 2295872
Nasal polyps 83.66 27.23 17 3612 199 2354257
Urticaria 80.77 27.23 55 3574 24206 2330250
Bronchitis 78.65 27.23 44 3585 13670 2340786
Oropharyngeal pain 77.27 27.23 41 3588 11477 2342979
Labile blood pressure 77.26 27.23 16 3613 207 2354249
Skin infection 76.61 27.23 23 3606 1427 2353029
Tachycardia 76.46 27.23 46 3583 16363 2338093
Eosinophilic bronchitis 74.95 27.23 11 3618 10 2354446
Pruritus 73.72 27.23 66 3563 43274 2311182
Adrenal insufficiency 73.07 27.23 22 3607 1378 2353078
Respiratory symptom 71.26 27.23 15 3614 211 2354245
Upper-airway cough syndrome 71.03 27.23 20 3609 988 2353468
Lower respiratory tract infection 69.08 27.23 30 3599 5394 2349062
Graft versus host disease in gastrointestinal tract 68.44 27.23 15 3614 258 2354198
Eosinophilia 67.73 27.23 25 3604 2945 2351511
Bronchospasm 67.29 27.23 25 3604 2999 2351457
Device issue 66.18 27.23 30 3599 5969 2348487
Throat tightness 64.66 27.23 27 3602 4409 2350047
Insomnia 64.15 27.23 49 3580 25738 2328718
Abdominal pain 63.73 27.23 55 3574 34319 2320137
Bronchiectasis 62.90 27.23 18 3611 943 2353513
Bronchopulmonary aspergillosis allergic 62.19 27.23 11 3618 56 2354400
Oedema peripheral 60.97 27.23 46 3583 23717 2330739
Blood immunoglobulin E increased 60.70 27.23 14 3615 306 2354150
Weight decreased 60.01 27.23 49 3580 28322 2326134
Diabetes mellitus 59.82 27.23 30 3599 7465 2346991
Lung disorder 58.98 27.23 28 3601 6184 2348272
Cytomegalovirus infection 58.79 27.23 22 3607 2691 2351765
Premature baby 58.74 27.23 23 3606 3181 2351275
Asthenia 58.07 27.23 60 3569 46866 2307590
Breath sounds abnormal 57.92 27.23 16 3613 736 2353720
Oral candidiasis 57.88 27.23 20 3609 1945 2352511
Muscular weakness 57.34 27.23 37 3592 14860 2339596
Graft versus host disease in skin 57.31 27.23 13 3616 263 2354193
Nasopharyngitis 57.25 27.23 43 3586 22013 2332443
Swollen tongue 56.67 27.23 26 3603 5317 2349139
Butterfly rash 54.88 27.23 12 3617 204 2354252
Drug interaction 54.71 27.23 47 3582 29116 2325340
Aspergillus infection 54.01 27.23 16 3613 947 2353509
Heart rate increased 53.95 27.23 32 3597 11073 2343383
Lung neoplasm malignant 52.83 27.23 21 3608 3021 2351435
Upper respiratory tract infection 52.35 27.23 29 3600 8822 2345634
Asthmatic crisis 51.73 27.23 12 3617 269 2354187
Oesophageal candidiasis 50.18 27.23 14 3615 668 2353788
Atrial fibrillation 50.05 27.23 33 3596 13735 2340721
Ageusia 49.94 27.23 18 3611 1980 2352476
Dysphagia 49.75 27.23 32 3597 12773 2341683
Lip swelling 49.68 27.23 23 3606 4798 2349658
Pulmonary function test decreased 49.61 27.23 13 3616 488 2353968
Aphonia 49.29 27.23 16 3613 1283 2353173
Rhinitis allergic 48.68 27.23 14 3615 746 2353710
Product packaging quantity issue 47.82 27.23 12 3617 378 2354078
Ill-defined disorder 47.34 27.23 20 3609 3358 2351098
Muscle spasms 47.17 27.23 38 3591 21528 2332928
Photosensitivity reaction 46.53 27.23 18 3611 2409 2352047
Arthralgia 45.95 27.23 57 3572 54228 2300228
Polyp 45.53 27.23 13 3616 675 2353781
Dysgeusia 45.38 27.23 26 3603 8433 2346023
Eczema 45.00 27.23 19 3610 3186 2351270
Adenovirus infection 44.48 27.23 11 3618 326 2354130
Tachypnoea 44.40 27.23 17 3612 2212 2352244
Feeling abnormal 44.20 27.23 38 3591 23543 2330913
Lung hyperinflation 43.55 27.23 9 3620 115 2354341
Pharyngeal oedema 43.42 27.23 19 3610 3474 2350982
Cryptosporidiosis infection 43.30 27.23 8 3621 54 2354402
Renal failure 43.18 27.23 33 3596 17316 2337140
Rhinorrhoea 42.78 27.23 24 3605 7476 2346980
Pseudomonas infection 42.77 27.23 14 3615 1152 2353304
Crohn's disease 42.66 27.23 23 3606 6632 2347824
Loss of personal independence in daily activities 41.61 27.23 21 3608 5290 2349166
Diarrhoea 41.49 27.23 68 3561 83496 2270960
Mouth ulceration 41.36 27.23 19 3610 3893 2350563
Congenital pulmonary hypertension 40.95 27.23 7 3622 28 2354428
Fatigue 40.70 27.23 68 3561 84805 2269651
Periorbital oedema 40.50 27.23 13 3616 1005 2353451
Middle insomnia 39.53 27.23 14 3615 1463 2352993
Blood pressure increased 39.42 27.23 31 3598 16955 2337501
Nervousness 39.14 27.23 20 3609 5169 2349287
Hypoaesthesia 38.73 27.23 33 3596 20182 2334274
Cyanosis 38.54 27.23 17 3612 3168 2351288
Product taste abnormal 38.47 27.23 11 3618 574 2353882
Human herpesvirus 6 infection 38.30 27.23 10 3619 370 2354086
Headache 38.11 27.23 64 3565 80115 2274341
Cushingoid 38.01 27.23 11 3618 599 2353857
Blood test abnormal 37.21 27.23 13 3616 1305 2353151
Haemoptysis 36.88 27.23 17 3612 3510 2350946
Cardiac failure 36.85 27.23 26 3603 12068 2342388
Eosinophilic oesophagitis 36.21 27.23 7 3622 62 2354394
Gastrointestinal haemorrhage 36.20 27.23 26 3603 12409 2342047
Device ineffective 35.72 27.23 7 3622 67 2354389
Therapeutic response decreased 35.63 27.23 21 3608 7174 2347282
Product dispensing error 35.45 27.23 15 3614 2526 2351930
Forced expiratory volume decreased 34.73 27.23 10 3619 535 2353921
Oxygen saturation decreased 34.60 27.23 21 3608 7565 2346891
Vision blurred 34.52 27.23 27 3602 14641 2339815
Hypoacusis 34.23 27.23 16 3613 3409 2351047
Wrong technique in product usage process 33.33 27.23 30 3599 19718 2334738
Colitis 33.31 27.23 18 3611 5208 2349248
Fall 32.87 27.23 45 3584 47054 2307402
Myalgia 32.77 27.23 32 3597 23301 2331155
Pyrexia 32.60 27.23 48 3581 53660 2300796
Laryngitis 32.35 27.23 12 3617 1431 2353025
Ductus arteriosus premature closure 32.16 27.23 6 3623 43 2354413
Haemorrhage 31.94 27.23 23 3606 11016 2343440
Fungal infection 31.61 27.23 17 3612 4872 2349584
Haematemesis 31.56 27.23 16 3613 4066 2350390
Seizure 31.49 27.23 32 3597 24434 2330022
Mycobacterial infection 31.26 27.23 8 3621 273 2354183
Feeling hot 31.14 27.23 19 3610 6909 2347547
Essential hypertension 31.08 27.23 9 3620 491 2353965
Tinnitus 30.83 27.23 17 3612 5118 2349338
Foetal heart rate abnormal 30.70 27.23 7 3622 145 2354311
Osteoporosis 30.38 27.23 16 3613 4398 2350058
Hypokalaemia 30.37 27.23 22 3607 10632 2343824
Total lung capacity increased 30.37 27.23 5 3624 15 2354441
Anosmia 30.10 27.23 10 3619 862 2353594
Pulmonary function test abnormal 29.88 27.23 7 3622 164 2354292
Pancoast's syndrome 29.84 27.23 4 3625 0 2354456
Type IV hypersensitivity reaction 29.81 27.23 9 3620 568 2353888
Malnutrition 29.75 27.23 12 3617 1791 2352665
Treatment noncompliance 29.64 27.23 17 3612 5517 2348939
Colitis microscopic 29.40 27.23 10 3619 926 2353530
Oliguria 29.38 27.23 11 3618 1346 2353110
Rhabdomyolysis 29.14 27.23 18 3611 6686 2347770
Hypoalbuminaemia 29.09 27.23 11 3618 1383 2353073
Contusion 28.89 27.23 23 3606 12787 2341669
Asphyxia 28.71 27.23 10 3619 994 2353462
Paraesthesia 28.62 27.23 29 3600 22059 2332397
Hyperplastic cholecystopathy 28.51 27.23 5 3624 24 2354432
Sinus congestion 28.51 27.23 12 3617 1995 2352461
Rash papular 28.44 27.23 13 3616 2631 2351825
Obstructive pancreatitis 28.18 27.23 5 3624 26 2354430
Dry mouth 28.09 27.23 19 3610 8234 2346222
Medication error 28.03 27.23 17 3612 6114 2348342
Cortisol decreased 27.97 27.23 7 3622 218 2354238
Atopy 27.87 27.23 5 3624 28 2354428
Depression 27.79 27.23 32 3597 28100 2326356
Sinusitis 27.68 27.23 25 3604 16501 2337955
Rhinitis 27.57 27.23 10 3619 1119 2353337
Stomatitis 27.56 27.23 20 3609 9690 2344766
Vomiting 27.36 27.23 52 3577 71550 2282906
Head discomfort 27.28 27.23 11 3618 1640 2352816

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 1178.15 31.31 265 2290 4639 1739587
Dyspnoea 747.46 31.31 322 2233 51737 1692489
Chronic obstructive pulmonary disease 554.32 31.31 151 2404 5802 1738424
Wheezing 436.11 31.31 116 2439 4037 1740189
Drug ineffective 304.90 31.31 190 2365 63611 1680615
Cough 291.61 31.31 125 2430 19072 1725154
Obstructive airways disorder 255.39 31.31 58 2497 1016 1743210
Cushing's syndrome 247.21 31.31 51 2504 553 1743673
Chest discomfort 199.67 31.31 73 2482 7258 1736968
Blood count abnormal 192.60 31.31 49 2506 1408 1742818
Intentional product misuse 162.93 31.31 63 2492 7295 1736931
Pneumonia 154.94 31.31 111 2444 46071 1698155
Off label use 151.05 31.31 102 2453 38469 1705757
Therapeutic product effect incomplete 150.99 31.31 55 2500 5393 1738833
Intentional device misuse 135.54 31.31 23 2532 72 1744154
Condition aggravated 133.70 31.31 76 2479 21074 1723152
Circumstance or information capable of leading to medication error 129.82 31.31 31 2524 678 1743548
Productive cough 121.24 31.31 42 2513 3549 1740677
Dysphonia 102.55 31.31 37 2518 3518 1740708
Drug interaction 102.17 31.31 71 2484 27887 1716339
Graft versus host disease 101.34 31.31 30 2525 1523 1742703
Hypertension 99.46 31.31 61 2494 19387 1724839
Device issue 99.35 31.31 33 2522 2449 1741777
Palpitations 95.12 31.31 42 2513 6772 1737454
Product dose omission 86.64 31.31 59 2496 22381 1721845
Product quality issue 86.46 31.31 38 2517 6055 1738171
Sputum discoloured 85.61 31.31 22 2533 655 1743571
Device malfunction 85.36 31.31 28 2527 1996 1742230
Chest pain 83.20 31.31 55 2500 19859 1724367
Bronchiectasis 74.64 31.31 19 2536 544 1743682
Herpes zoster meningoencephalitis 74.51 31.31 13 2542 50 1744176
Malaise 72.10 31.31 59 2496 29506 1714720
Dyspnoea exertional 69.04 31.31 29 2526 4132 1740094
Product use in unapproved indication 67.91 31.31 37 2518 9385 1734841
Cushingoid 65.95 31.31 16 2539 374 1743852
Pulmonary mass 65.86 31.31 21 2534 1366 1742860
Lower respiratory tract infection 64.42 31.31 27 2528 3824 1740402
Candida infection 62.56 31.31 22 2533 1936 1742290
Reversible airways obstruction 62.44 31.31 10 2545 19 1744207
Colitis microscopic 61.81 31.31 15 2540 351 1743875
Oropharyngeal pain 61.76 31.31 28 2527 4790 1739436
Cataract 60.33 31.31 24 2531 2974 1741252
Pulmonary mycosis 59.59 31.31 13 2542 186 1744040
Bronchitis 58.55 31.31 28 2527 5404 1738822
Laryngitis 57.35 31.31 14 2541 336 1743890
Foetal distress syndrome 57.11 31.31 13 2542 228 1743998
Blood test abnormal 56.49 31.31 17 2538 911 1743315
Aphonia 56.26 31.31 15 2540 516 1743710
Adrenal insufficiency 53.99 31.31 18 2537 1347 1742879
Respiratory failure 53.19 31.31 37 2518 14468 1729758
Asthmatic crisis 52.68 31.31 11 2544 126 1744100
Oral candidiasis 50.74 31.31 17 2538 1292 1742934
Throat irritation 49.58 31.31 18 2537 1736 1742490
Insomnia 49.36 31.31 37 2518 16239 1727987
Product use issue 49.16 31.31 29 2526 8542 1735684
Bronchopulmonary aspergillosis allergic 49.02 31.31 9 2546 49 1744177
Periumbilical abscess 47.38 31.31 7 2548 5 1744221
Gastrooesophageal reflux disease 47.19 31.31 23 2532 4624 1739602
Vision blurred 47.00 31.31 28 2527 8395 1735831
Bronchospasm 46.57 31.31 18 2537 2064 1742162
Weight increased 46.44 31.31 31 2524 11326 1732900
Muscle spasms 45.79 31.31 31 2524 11590 1732636
Tachycardia 45.78 31.31 32 2523 12596 1731630
Diarrhoea 45.65 31.31 61 2494 53791 1690435
Sinusitis 44.64 31.31 23 2532 5200 1739026
Osteoporosis 44.10 31.31 16 2539 1539 1742687
Diabetes mellitus 43.93 31.31 25 2530 6883 1737343
Functional gastrointestinal disorder 42.64 31.31 11 2544 332 1743894
Renal failure 42.61 31.31 37 2518 19980 1724246
Cortisol decreased 42.31 31.31 10 2545 208 1744018
Hypoxia 41.77 31.31 23 2532 5940 1738286
Crohn's disease 41.52 31.31 21 2534 4566 1739660
Rash erythematous 41.38 31.31 20 2535 3945 1740281
Drug hypersensitivity 40.60 31.31 32 2523 15103 1729123
Eosinophilia 40.50 31.31 19 2536 3508 1740718
Foetal growth restriction 39.35 31.31 12 2543 672 1743554
Arthritis 38.34 31.31 19 2536 3956 1740270
Device failure 37.91 31.31 12 2543 761 1743465
Tremor 37.90 31.31 29 2526 13102 1731124
Nasal polyps 37.73 31.31 9 2546 195 1744031
Psychiatric symptom 37.41 31.31 12 2543 794 1743432
Epstein-Barr virus infection 37.30 31.31 13 2542 1112 1743114
Immunosuppressant drug level increased 36.79 31.31 11 2544 576 1743650
Respiratory tract infection 36.78 31.31 16 2539 2477 1741749
Bronchopulmonary aspergillosis 36.67 31.31 14 2541 1552 1742674
Cytomegalovirus enteritis 36.61 31.31 7 2548 49 1744177
Feeling jittery 36.59 31.31 12 2543 852 1743374
Vasculitis 36.59 31.31 14 2541 1561 1742665
Nasal congestion 36.46 31.31 17 2538 3094 1741132
Disseminated cryptococcosis 36.31 31.31 8 2547 120 1744106
Arrhythmia 36.18 31.31 21 2534 5995 1738231
Blood pressure increased 36.08 31.31 26 2529 10727 1733499
Gastroenteritis clostridial 36.01 31.31 7 2548 54 1744172
Dry mouth 35.66 31.31 18 2537 3895 1740331
Dizziness 35.49 31.31 43 2512 34318 1709908
Nervousness 35.18 31.31 15 2540 2212 1742014
Sleep disorder 35.02 31.31 18 2537 4045 1740181
Adrenal suppression 34.89 31.31 8 2547 145 1744081
Neurological symptom 34.85 31.31 11 2544 691 1743535
Pulmonary interstitial emphysema syndrome 34.40 31.31 6 2549 23 1744203
Loss of personal independence in daily activities 34.10 31.31 15 2540 2384 1741842
Nervous system disorder 33.78 31.31 15 2540 2439 1741787
Anxiety 33.63 31.31 29 2526 15498 1728728
Hypoacusis 33.43 31.31 15 2540 2498 1741728
Respiratory disorder 33.20 31.31 16 2539 3133 1741093
Skin necrosis 33.11 31.31 11 2544 813 1743413
Necrotising ulcerative gingivostomatitis 33.07 31.31 5 2550 5 1744221
Weight decreased 32.98 31.31 34 2521 22719 1721507
Rash 32.97 31.31 44 2511 38649 1705577
Osteonecrosis 32.56 31.31 17 2538 3945 1740281
Pyrexia 32.47 31.31 48 2507 46352 1697874
Atrial fibrillation 32.27 31.31 28 2527 15083 1729143
Headache 32.26 31.31 41 2514 34335 1709891
Chronic sinusitis 31.58 31.31 8 2547 224 1744002
Alveolar lung disease 31.50 31.31 6 2549 41 1744185

Pharmacologic Action:

SourceCodeDescription
ATC A07EA06 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
INTESTINAL ANTIINFLAMMATORY AGENTS
Corticosteroids acting locally
ATC D07AC09 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, potent (group III)
ATC R01AD05 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R03BA02 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Glucocorticoids
ATC R03AK07 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK12 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AL11 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D001993 Bronchodilator Agents
MeSH PA D005938 Glucocorticoids
MeSH PA D006728 Hormones
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D019141 Respiratory System Agents
CHEBI has role CHEBI:35523 bronchodilator agent
CHEBI has role CHEBI:35472 anti-inflammatory drug
CHEBI has role CHEBI:88188 drug allergen
FDA EPC N0000175576 Corticosteroid
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Crohn's disease indication 34000006
Allergic rhinitis indication 61582004
Asthma indication 195967001 DOID:2841
Asthma management indication 406162001
Crohn's disease in remission indication 426549001
Chronic Non-Allergic Rhinitis indication
Allergic Rhinitis Prevention indication
Severe chronic obstructive pulmonary disease off-label use 313299006
Infection by Strongyloides contraindication 1214006 DOID:10955
Mycosis contraindication 3218000 DOID:1564
Ocular hypertension contraindication 4210003 DOID:9282
Gastritis contraindication 4556007 DOID:4029
Inactive tuberculosis contraindication 11999007
Epistaxis contraindication 12441001
Peptic ulcer contraindication 13200003 DOID:750
Hypercholesterolemia contraindication 13644009
Measles contraindication 14189004 DOID:8622
Disease caused by parasite contraindication 17322007
Cirrhosis of liver contraindication 19943007 DOID:5082
Arginase deficiency contraindication 23501004 DOID:9278
Glaucoma contraindication 23986001 DOID:1686
Acute tuberculosis contraindication 25629007
Viral disease contraindication 34014006 DOID:934
Immunosuppression contraindication 38013005
Hypertensive disorder contraindication 38341003 DOID:10763
Infectious disease contraindication 40733004
Hypothyroidism contraindication 40930008 DOID:1459
Hypokalemia contraindication 43339004
Hypercortisolism contraindication 47270006
Chronic heart failure contraindication 48447003
Cerebral malaria contraindication 53622003 DOID:14069
Tuberculosis contraindication 56717001
Congenital hyperammonemia, type I contraindication 62522004
Osteoporosis contraindication 64859006 DOID:11476
Psychotic disorder contraindication 69322001
Diabetes mellitus contraindication 73211009 DOID:9351
Hypopituitarism contraindication 74728003 DOID:9406
Perforation of nasal septum contraindication 80142000
Hyperglycemia contraindication 80394007 DOID:4195
Open-angle glaucoma contraindication 84494001 DOID:1067
Bacterial infectious disease contraindication 87628006
Muscle atrophy contraindication 88092000 DOID:767
Herpes simplex contraindication 88594005 DOID:8566
Operation on nose contraindication 88733004
Bilateral cataracts contraindication 95722004
Seizure disorder contraindication 128613002
Disorder of muscle contraindication 129565002 DOID:423
Pulmonary tuberculosis contraindication 154283005 DOID:2957
Ophthalmic herpes simplex contraindication 186542001
Anastomosis of intestine contraindication 235407009
Disease of liver contraindication 235856003 DOID:409
Edema contraindication 267038008
Pathological fracture contraindication 268029009
Diverticulitis of gastrointestinal tract contraindication 271366000
Cerebral trauma contraindication 275382005
Varicella-zoster virus infection contraindication 309465005
Osteopenia contraindication 312894000
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Avascular necrosis of bone contraindication 397758007 DOID:10159
Citrullinemia contraindication 398680004 DOID:9273
Traumatic rupture of tendon contraindication 415749005
Exposure to varicella contraindication 444453009
Oropharyngeal Candidiasis contraindication
Nasal Septal Ulcers contraindication
Uncontrolled Bacterial Infections contraindication
Nasal Trauma contraindication
Untreated Fungal Infection contraindication
Arginosuccinate Lyase Deficiency contraindication
Nasal Candidiasis contraindication
Ornithine Carbamyltransferase Deficiency contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.8 acidic
pKa2 12.78 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
9MG UCERIS SALIX N203634 Jan. 14, 2013 RX TABLET, EXTENDED RELEASE ORAL 10064878 June 9, 2020 INDUCTION OF REMISSION IN PATIENTS WITH ACTIVE, MILD TO MODERATE ULCERATIVE COLITIS
9MG UCERIS SALIX N203634 Jan. 14, 2013 RX TABLET, EXTENDED RELEASE ORAL 10105374 June 9, 2020 INDUCTION OF REMISSION IN PATIENTS WITH ACTIVE, MILD TO MODERATE ULCERATIVE COLITIS
9MG UCERIS SALIX N203634 Jan. 14, 2013 RX TABLET, EXTENDED RELEASE ORAL 10143698 June 9, 2020 INDUCTION OF REMISSION IN PATIENTS WITH ACTIVE, MILD TO MODERATE ULCERATIVE COLITIS
9MG UCERIS SALIX N203634 Jan. 14, 2013 RX TABLET, EXTENDED RELEASE ORAL 7410651 June 9, 2020 INDUCTION OF REMISSION IN PATIENTS WITH ACTIVE, MILD TO MODERATE ULCERATIVE COLITIS
9MG UCERIS SALIX N203634 Jan. 14, 2013 RX TABLET, EXTENDED RELEASE ORAL 9320716 June 9, 2020 INDUCTION OF REMISSION IN PATIENTS WITH ACTIVE, MILD TO MODERATE ULCERATIVE COLITIS
9MG UCERIS SALIX N203634 Jan. 14, 2013 RX TABLET, EXTENDED RELEASE ORAL 9532954 June 9, 2020 INDUCTION OF REMISSION IN PATIENTS WITH ACTIVE, MILD TO MODERATE ULCERATIVE COLITIS
9MG UCERIS SALIX N203634 Jan. 14, 2013 RX TABLET, EXTENDED RELEASE ORAL RE43799 June 9, 2020 INDUCTION OF REMISSION IN PATIENTS WITH ACTIVE, MILD TO MODERATE ULCERATIVE COLITIS
0.08MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
9MG UCERIS SALIX N203634 Jan. 14, 2013 RX TABLET, EXTENDED RELEASE ORAL 9192581 Sept. 7, 2031 INDUCTION OF REMISSION IN PATIENTS WITH ACTIVE, MILD TO MODERATE ULCERATIVE COLITIS
6MG ORTIKOS SUN PHARMA GLOBAL N211929 June 13, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10172802 Sept. 9, 2036 TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON
6MG ORTIKOS SUN PHARMA GLOBAL N211929 June 13, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 9707182 Sept. 9, 2036 TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON
9MG ORTIKOS SUN PHARMA GLOBAL N211929 June 13, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 10172802 Sept. 9, 2036 TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON
9MG ORTIKOS SUN PHARMA GLOBAL N211929 June 13, 2019 RX CAPSULE, EXTENDED RELEASE ORAL 9707182 Sept. 9, 2036 TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.08MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION Jan. 27, 2020 NEW PATIENT POPULATION
0.08MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION July 27, 2020 PEDIATRIC EXCLUSIVITY
0.08MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION Sept. 11, 2020 INFORMATION ADDED TO LABELING TO SUPPORT THE USE OF SYMBICORT TO REDUCE EXACERBATIONS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION Sept. 11, 2020 INFORMATION ADDED TO LABELING TO SUPPORT THE USE OF SYMBICORT TO REDUCE EXACERBATIONS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.08MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION Dec. 20, 2020 INFORMATION ADDED TO THE CLINICAL TRIALS SECTION OF THE LABELING REGARDING A POSTMARKETING SAFETY AND EFFICACY STUDY EVALUATING THE RISK OF SERIOUS ASTHMA-RELATED EVENTS
0.16MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION Dec. 20, 2020 INFORMATION ADDED TO THE CLINICAL TRIALS SECTION OF THE LABELING REGARDING A POSTMARKETING SAFETY AND EFFICACY STUDY EVALUATING THE RISK OF SERIOUS ASTHMA-RELATED EVENTS

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST EC50 10.30 WOMBAT-PK CHEMBL
Interleukin-5 Cytokine IC50 9.92 WOMBAT-PK
Matrix metalloproteinase-9 Enzyme IC50 5.70 DRUG MATRIX
Multidrug resistance protein 1 Transporter WOMBAT-PK
Mineralocorticoid receptor Nuclear hormone receptor AGONIST EC50 7.85 IUPHAR
Interferon gamma Cytokine IC50 9.50 WOMBAT-PK
Progesterone receptor Nuclear hormone receptor AGONIST EC50 7.55 IUPHAR
Androgen receptor Transcription factor Ki 5.96 DRUG MATRIX
Progesterone receptor Transcription factor Ki 7.57 DRUG MATRIX
Interleukin-5 Unclassified IC50 4.58 CHEMBL
Glucocorticoid receptor Transcription factor IC50 8.54 CHEMBL

External reference:

IDSource
4020889 VUID
N0000148384 NUI
C0054201 UMLSCUI
D00246 KEGG_DRUG
108622005 SNOMEDCT_US
4020889 VANDF
004214 NDDF
44092 MMSL
19831 RXNORM
395726003 SNOMEDCT_US
4303 MMSL
d04276 MMSL
CHEMBL1370 ChEMBL_ID
Q3OKS62Q6X UNII
4145 INN_ID
DB01222 DRUGBANK_ID
CHEBI:3207 CHEBI
7434 IUPHAR_LIGAND_ID
D019819 MESH_DESCRIPTOR_UI
5281004 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-6815 SUSPENSION 0.25 mg RESPIRATORY (INHALATION) ANDA 17 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-6816 SUSPENSION 0.50 mg RESPIRATORY (INHALATION) ANDA 17 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-6817 SUSPENSION 1 mg RESPIRATORY (INHALATION) ANDA 17 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-7445 CAPSULE, DELAYED RELEASE PELLETS 3 mg ORAL ANDA 18 sections
Budesonide Inhalation HUMAN PRESCRIPTION DRUG LABEL 1 0115-1687 SUSPENSION 0.25 mg RESPIRATORY (INHALATION) ANDA 17 sections
Budesonide Inhalation HUMAN PRESCRIPTION DRUG LABEL 1 0115-1689 SUSPENSION 0.50 mg RESPIRATORY (INHALATION) ANDA 17 sections
SYMBICORT HUMAN PRESCRIPTION DRUG LABEL 1 0186-0370 AEROSOL 160 ug RESPIRATORY (INHALATION) NDA 17 sections
SYMBICORT HUMAN PRESCRIPTION DRUG LABEL 1 0186-0372 AEROSOL 80 ug RESPIRATORY (INHALATION) NDA 17 sections
PULMICORT HUMAN PRESCRIPTION DRUG LABEL 1 0186-0916 AEROSOL, POWDER 180 ug RESPIRATORY (INHALATION) NDA 17 sections
PULMICORT HUMAN PRESCRIPTION DRUG LABEL 1 0186-0917 AEROSOL, POWDER 90 ug RESPIRATORY (INHALATION) NDA 17 sections
PULMICORT RESPULES HUMAN PRESCRIPTION DRUG LABEL 1 0186-1988 SUSPENSION 0.25 mg RESPIRATORY (INHALATION) NDA 17 sections
PULMICORT RESPULES HUMAN PRESCRIPTION DRUG LABEL 1 0186-1989 SUSPENSION 0.50 mg RESPIRATORY (INHALATION) NDA 17 sections
PULMICORT RESPULES HUMAN PRESCRIPTION DRUG LABEL 1 0186-1990 SUSPENSION 1 mg RESPIRATORY (INHALATION) NDA 17 sections
Budesonide and Formoterol Fumarate Dihydrate HUMAN PRESCRIPTION DRUG LABEL 1 0310-7370 AEROSOL 160 ug RESPIRATORY (INHALATION) NDA authorized generic 17 sections
Budesonide and Formoterol Fumarate Dihydrate HUMAN PRESCRIPTION DRUG LABEL 1 0310-7372 AEROSOL 80 ug RESPIRATORY (INHALATION) NDA authorized generic 17 sections
Budesonide HUMAN OTC DRUG LABEL 1 0363-0048 SPRAY, METERED 32 ug NASAL ANDA 9 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0378-7155 CAPSULE 3 mg ORAL ANDA 18 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0487-9601 INHALANT 0.25 mg RESPIRATORY (INHALATION) ANDA 18 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0487-9701 INHALANT 0.50 mg RESPIRATORY (INHALATION) ANDA 18 sections
Budesonide HUMAN OTC DRUG LABEL 1 0536-1112 SPRAY, METERED 32 ug NASAL ANDA 9 sections
Entocort EC HUMAN PRESCRIPTION DRUG LABEL 1 0574-9850 CAPSULE 3 mg ORAL NDA 20 sections
budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0574-9855 CAPSULE 3 mg ORAL NDA 19 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0591-2510 TABLET, FILM COATED, EXTENDED RELEASE 9 mg ORAL ANDA 18 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0781-7515 SUSPENSION 0.25 mg RESPIRATORY (INHALATION) ANDA 17 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0781-7516 SUSPENSION 0.50 mg RESPIRATORY (INHALATION) ANDA 17 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0781-7517 SUSPENSION 1 mg RESPIRATORY (INHALATION) ANDA 17 sections
Budesonide HUMAN OTC DRUG LABEL 1 11822-1700 SPRAY, METERED 32 ug NASAL ANDA 9 sections
Budesonide HUMAN OTC DRUG LABEL 1 11822-6000 SPRAY, METERED 32 ug NASAL ANDA 9 sections
budesonide HUMAN PRESCRIPTION DRUG LABEL 1 16714-829 CAPSULE, COATED PELLETS 3 mg ORAL ANDA 19 sections
Budesonide HUMAN OTC DRUG LABEL 1 21130-710 SPRAY, METERED 32 ug NASAL ANDA 9 sections