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

Stem definitionDrug idCAS RN
antihistaminics 271 58581-89-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • azelastine
  • azelastine hydrochloride
  • azelastine HCl
Azelastine hydrochloride, a phthalazinone derivative, exhibits histamine H1-receptor antagonist activity in isolated tissues, animal models, and humans. Azelastine Hydrochloride is administered as a racemic mixture with no difference in pharmacologic activity noted between the enantiomers in in vitro studies. The major metabolite, desmethylazelastine, also possesses H1-receptor antagonist activity.
  • Molecular weight: 381.90
  • Formula: C22H24ClN3O
  • CLOGP: 4.01
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 0
  • TPSA: 35.91
  • ALOGS: -4.62
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.56 mg N
4 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.30 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 15 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.17 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 22 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 1, 1996 FDA MEDA PHARMS

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
Treatment failure 241.65 14.59 253 13356 198790 63276623
Sinusitis 186.89 14.59 236 13373 226417 63248996
Asthma 108.34 14.59 135 13474 127426 63347987
COVID-19 87.02 14.59 114 13495 112989 63362424
Product dose omission issue 80.77 14.59 164 13445 234149 63241264
Infusion site swelling 68.53 14.59 36 13573 9734 63465679
Infusion site erythema 59.86 14.59 35 13574 11644 63463769
Impaired quality of life 57.00 14.59 36 13573 13747 63461666
Sinus disorder 50.55 14.59 42 13567 24511 63450902
Cough 47.32 14.59 154 13455 292589 63182824
Infusion site pain 45.84 14.59 34 13575 16835 63458578
Infusion site pruritus 44.51 14.59 23 13586 6012 63469401
Bronchitis 43.61 14.59 88 13521 124847 63350566
Toxicity to various agents 41.48 14.59 3 13606 247247 63228166
Headache 41.42 14.59 254 13355 632987 62842426
Illness 38.53 14.59 50 13559 49009 63426404
Infusion site haemorrhage 36.41 14.59 19 13590 5067 63470346
Contraindicated product administered 35.49 14.59 3 13606 217645 63257768
Infusion site extravasation 32.87 14.59 23 13586 10403 63465010
Dermatitis atopic 31.94 14.59 22 13587 9702 63465711
Ear infection 31.66 14.59 40 13569 38173 63437240
Seasonal allergy 31.49 14.59 30 13579 20920 63454493
Multiple allergies 31.33 14.59 25 13584 13777 63461636
Hepatic enzyme increased 29.89 14.59 4 13605 202324 63273089
Upper respiratory tract infection 27.67 14.59 57 13552 81990 63393423
Drug intolerance 27.54 14.59 16 13593 308645 63166768
General physical health deterioration 27.45 14.59 5 13604 201397 63274016
Systemic lupus erythematosus 26.78 14.59 6 13603 208912 63266501
Infusion site bruising 26.53 14.59 14 13595 3818 63471595
Nasal congestion 25.01 14.59 48 13561 65612 63409801
Pre-existing condition improved 23.26 14.59 17 13592 8227 63467186
Glossodynia 23.20 14.59 5 13604 178871 63296542
Nasal discomfort 21.11 14.59 13 13596 4747 63470666
Injection site swelling 20.91 14.59 37 13572 47535 63427878
Drug interaction 20.25 14.59 12 13597 229119 63246294
Migraine 20.03 14.59 58 13551 103288 63372125
Surgery 19.90 14.59 31 13578 35881 63439532
Dry skin 18.56 14.59 39 13570 56848 63418565
Eye pruritus 17.82 14.59 21 13588 18650 63456763
Maternal exposure during pregnancy 17.46 14.59 13 13596 220049 63255364
Therapeutic product effect decreased 17.24 14.59 10 13599 193177 63282236
Arthropathy 17.22 14.59 15 13594 234777 63240636
Fatigue 16.79 14.59 275 13334 887753 62587660
Wound 16.76 14.59 7 13602 163256 63312157
Upper-airway cough syndrome 16.50 14.59 16 13593 11402 63464011
Administration site pruritus 16.38 14.59 5 13604 324 63475089
Chest discomfort 16.07 14.59 56 13553 109913 63365500
Product administration interrupted 16.02 14.59 11 13598 4825 63470588
Product delivery mechanism issue 15.77 14.59 5 13604 367 63475046
Neutropenia 15.70 14.59 9 13600 174996 63300417
Hereditary angioedema 15.69 14.59 13 13596 7549 63467864
Joint swelling 15.65 14.59 29 13580 327637 63147776
Product taste abnormal 15.59 14.59 8 13601 2059 63473354
Incorrect drug administration rate 15.51 14.59 10 13599 3952 63471461
Product use in unapproved indication 15.04 14.59 77 13532 179003 63296410
Infusion site nodule 14.92 14.59 7 13602 1485 63473928
Urinary tract infection 14.64 14.59 102 13507 264582 63210831
Product quality issue 14.62 14.59 27 13582 35838 63439575

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
Treatment failure 218.82 18.60 118 5346 46579 34904888
Sinusitis 91.74 18.60 65 5399 41337 34910130
Asthma 38.44 18.60 40 5424 42616 34908851
Transferrin increased 35.36 18.60 5 5459 5 34951462
Chorioretinopathy 31.63 18.60 11 5453 1482 34949985
Impaired quality of life 30.81 18.60 16 5448 5802 34945665
Oesophageal injury 28.69 18.60 5 5459 33 34951434
Product dose omission issue 27.62 18.60 59 5405 119652 34831815
Product delivery mechanism issue 26.62 18.60 6 5458 162 34951305
Ear infection 20.19 18.60 15 5449 10216 34941251
pH body fluid increased 19.24 18.60 4 5460 73 34951394
Cardiac valve sclerosis 18.89 18.60 4 5460 80 34951387

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
Sinusitis 125.37 14.53 159 13221 195342 79535666
Asthma 103.01 14.53 120 13260 134975 79596033
Product dose omission issue 74.48 14.53 142 13238 247395 79483613
Toxicity to various agents 58.42 14.53 3 13377 421537 79309471
Impaired quality of life 58.39 14.53 34 13346 14352 79716656
COVID-19 56.98 14.53 98 13282 157576 79573432
Headache 42.56 14.53 219 13161 653553 79077455
Infusion site swelling 38.54 14.53 21 13359 7805 79723203
Sinus disorder 38.12 14.53 31 13349 22433 79708575
Infusion site pain 36.21 14.53 25 13355 14151 79716857
Dermatitis atopic 36.20 14.53 22 13358 10034 79720974
Bronchitis 34.46 14.53 71 13309 130573 79600435
Cough 33.59 14.53 136 13244 366653 79364355
Fatigue 32.95 14.53 267 13113 929460 78801548
General physical health deterioration 32.46 14.53 4 13376 275234 79455774
Infusion site erythema 29.77 14.53 19 13361 9441 79721567
Transferrin increased 29.51 14.53 5 13375 25 79730983
Infusion site bruising 26.75 14.53 12 13368 2940 79728068
Chorioretinopathy 26.56 14.53 11 13369 2220 79728788
Illness 25.36 14.53 35 13345 46476 79684532
Ear infection 25.22 14.53 30 13350 34402 79696606
Drug interaction 23.57 14.53 21 13359 415162 79315846
Oesophageal injury 23.12 14.53 5 13375 103 79730905
Infusion site pruritus 22.95 14.53 12 13368 4106 79726902
Seasonal allergy 22.43 14.53 20 13360 16386 79714622
Product quality issue 22.31 14.53 28 13352 33912 79697096
Nasal congestion 21.84 14.53 43 13337 76509 79654499
Chest discomfort 20.32 14.53 60 13320 137984 79593024
Upper respiratory tract infection 19.98 14.53 46 13334 91122 79639886
Product use in unapproved indication 19.91 14.53 89 13291 250270 79480738
Injection site swelling 19.28 14.53 31 13349 47101 79683907
Insurance issue 19.25 14.53 12 13368 5721 79725287
Multiple allergies 18.95 14.53 15 13365 10445 79720563
Infusion site thrombosis 18.83 14.53 5 13375 251 79730757
pH body fluid increased 18.66 14.53 4 13376 79 79730929
Acute kidney injury 18.55 14.53 37 13343 519367 79211641
Infusion site haemorrhage 18.37 14.53 10 13370 3710 79727298
Thrombocytopenia 18.17 14.53 11 13369 265248 79465760
Acute respiratory failure 17.65 14.53 34 13346 59507 79671501
Upper-airway cough syndrome 17.48 14.53 15 13365 11678 79719330
Cardiac valve sclerosis 17.29 14.53 4 13376 113 79730895
Dyspnoea 17.14 14.53 219 13161 856806 78874202
Pneumonia 16.89 14.53 177 13203 660069 79070939
Eye pruritus 16.87 14.53 19 13361 20551 79710457
Gastrointestinal submucosal tumour 16.84 14.53 4 13376 127 79730881
Sinus operation 15.93 14.53 8 13372 2517 79728491
Flushing 15.58 14.53 41 13339 88227 79642781
Product administration interrupted 15.25 14.53 9 13371 3890 79727118
Hereditary angioedema 15.03 14.53 10 13370 5325 79725683
Incorrect drug administration rate 14.98 14.53 9 13371 4017 79726991
Treatment failure 14.91 14.53 5 13375 170481 79560527
Nasal operation 14.87 14.53 4 13376 211 79730797
Nasal discomfort 14.78 14.53 10 13370 5473 79725535
Therapy interrupted 14.76 14.53 22 13358 31319 79699689

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R01AC03 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Antiallergic agents, excl. corticosteroids
ATC R06AX19 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Other antihistamines for systemic use
ATC S01GX07 SENSORY ORGANS
OPHTHALMOLOGICALS
DECONGESTANTS AND ANTIALLERGICS
Other antiallergics
FDA MoA N0000000190 Histamine H1 Receptor Antagonists
FDA EPC N0000175587 Histamine-1 Receptor Antagonist
CHEBI has role CHEBI:35523 bronchodilator
CHEBI has role CHEBI:37955 H1 receptor antagonists
CHEBI has role CHEBI:49167 anti-asthmatic drugs
CHEBI has role CHEBI:50427 platelet aggregation inhibitors
CHEBI has role CHEBI:50857 anti-allergic drugs
CHEBI has role CHEBI:64964 5delta-lipoxygenase inhibitor
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D001993 Bronchodilator Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D039563 Histamine H1 Antagonists, Non-Sedating
MeSH PA D016859 Lipoxygenase Inhibitors
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D019141 Respiratory System Agents

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

DiseaseRelationSNOMED_IDDOID
Vasomotor rhinitis indication 8229003 DOID:4730
Allergic rhinitis indication 61582004
Seasonal allergic rhinitis indication 367498001
Allergic conjunctivitis indication 473460002 DOID:11204
Kidney disease contraindication 90708001 DOID:557
Drowsy contraindication 271782001
Ocular Irritation contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.91 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.137MG/SPRAY;0.05MG/SPRAY DYMISTA MYLAN SPECIALITY LP N202236 May 1, 2012 RX SPRAY, METERED NASAL 9259428 June 13, 2023 TREATMENT OF SEASONAL ALLERGIC RHINITIS
0.137MG/SPRAY;0.05MG/SPRAY DYMISTA MYLAN SPECIALITY LP N202236 May 1, 2012 RX SPRAY, METERED NASAL 8163723 Aug. 29, 2023 ALLERGIC RHINITIS
0.137MG/SPRAY;0.05MG/SPRAY DYMISTA MYLAN SPECIALITY LP N202236 May 1, 2012 RX SPRAY, METERED NASAL 8163723 Aug. 29, 2023 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS
0.137MG/SPRAY;0.05MG/SPRAY DYMISTA MYLAN SPECIALITY LP N202236 May 1, 2012 RX SPRAY, METERED NASAL 8163723 Aug. 29, 2023 TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL ALLERGIC RHINITIS
0.137MG/SPRAY;0.05MG/SPRAY DYMISTA MYLAN SPECIALITY LP N202236 May 1, 2012 RX SPRAY, METERED NASAL 8163723 Aug. 29, 2023 TREATMENT OF SEASONAL ALLERGIC RHINITIS
0.137MG/SPRAY;0.05MG/SPRAY DYMISTA MYLAN SPECIALITY LP N202236 May 1, 2012 RX SPRAY, METERED NASAL 8163723 Aug. 29, 2023 TREATMENT OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ASTEPRO MYLAN SPECIALITY LP N022203 Oct. 15, 2008 DISCN SPRAY, METERED NASAL 8518919 Nov. 22, 2025 TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS
0.2055MG/SPRAY ASTEPRO MYLAN SPECIALITY LP N022203 Aug. 31, 2009 DISCN SPRAY, METERED NASAL 8518919 Nov. 22, 2025 TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS
0.2055MG/SPRAY ASTEPRO ALLERGY BAYER HLTHCARE N213872 June 17, 2021 OTC SPRAY, METERED NASAL 8518919 Nov. 22, 2025 OTC USE: ALLERGY SYMPTOM RELIEVER; TEMPORARY RELIEF OF THESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES: NASAL CONGESTION, RUNNY NOSE, SNEEZING AND ITCHY NOSE
0.2055MG/SPRAY CHILDRENS ASTEPRO ALLERGY BAYER HLTHCARE N213872 June 17, 2021 OTC SPRAY, METERED NASAL 8518919 Nov. 22, 2025 OTC USE: ALLERGY SYMPTOM RELIEVER; TEMPORARY RELIEF OF THESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES: NASAL CONGESTION, RUNNY NOSE, SNEEZING AND ITCHY NOSE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Histamine H1 receptor GPCR ANTAGONIST Ki 8.17 WOMBAT-PK CHEMBL
Multidrug resistance protein 1 Transporter WOMBAT-PK
5-hydroxytryptamine receptor 2B GPCR Ki 7.70 CHEMBL
5-hydroxytryptamine receptor 2C GPCR Ki 6.30 CHEMBL
Alpha-1A adrenergic receptor GPCR Ki 7.30 CHEMBL
Muscarinic acetylcholine receptor M1 GPCR IC50 5.20 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 7.30 CHEMBL
Histamine H3 receptor GPCR Ki 6.83 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 7 CHEMBL
Alpha-1A adrenergic receptor GPCR Ki 7.30 CHEMBL

External reference:

IDSource
4024042 VUID
N0000022047 NUI
D00659 KEGG_DRUG
79307-93-0 SECONDARY_CAS_RN
18603 RXNORM
C0052762 UMLSCUI
CHEBI:2951 CHEBI
CHEMBL639 ChEMBL_ID
DB00972 DRUGBANK_ID
CHEMBL1200809 ChEMBL_ID
C020976 MESH_SUPPLEMENTAL_RECORD_UI
2267 PUBCHEM_CID
7121 IUPHAR_LIGAND_ID
4074 INN_ID
ZQI909440X UNII
169403 MMSL
4237 MMSL
8899 MMSL
108644000 SNOMEDCT_US
108646003 SNOMEDCT_US
372520005 SNOMEDCT_US
4021001 VANDF
4024042 VANDF
003931 NDDF
003932 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DYMISTA HUMAN PRESCRIPTION DRUG LABEL 2 0037-0245 SPRAY, METERED 137 ug NASAL NDA 29 sections
DYMISTA HUMAN PRESCRIPTION DRUG LABEL 2 0037-0245 SPRAY, METERED 137 ug NASAL NDA 29 sections
Azelastine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-0293 SPRAY, METERED 137 ug NASAL ANDA 27 sections
Astepro Allergy HUMAN OTC DRUG LABEL 1 0280-0065 SPRAY, METERED 205.50 ug NASAL NDA 16 sections
Astepro Allergy HUMAN OTC DRUG LABEL 1 0280-0065 SPRAY, METERED 205.50 ug NASAL NDA 16 sections
Children Astepro Allergy HUMAN OTC DRUG LABEL 1 0280-0066 SPRAY, METERED 205.50 ug NASAL NDA 16 sections
Azelastine Hydrochloride and Fluticasone Propionate HUMAN PRESCRIPTION DRUG LABEL 2 0378-3458 SPRAY, METERED 137 ug NASAL NDA authorized generic 29 sections
Azelastine Hydrochloride and Fluticasone Propionate HUMAN PRESCRIPTION DRUG LABEL 2 0378-3458 SPRAY, METERED 137 ug NASAL NDA authorized generic 29 sections
Azelastine Hydrochloride and Fluticasone Propionate HUMAN PRESCRIPTION DRUG LABEL 2 0378-3458 SPRAY, METERED 137 ug NASAL NDA authorized generic 29 sections
Azelastine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 17478-718 SOLUTION/ DROPS 0.50 mg OPHTHALMIC ANDA 10 sections
Azelastine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42291-094 SPRAY, METERED 1 mg NASAL ANDA 27 sections
Azelastine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42291-094 SPRAY, METERED 1 mg NASAL ANDA 27 sections
azelastine hcl nasal HUMAN PRESCRIPTION DRUG LABEL 1 45802-026 SPRAY 205.50 ug NASAL ANDA 27 sections
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE HUMAN PRESCRIPTION DRUG LABEL 2 45802-066 SPRAY, METERED 137 ug NASAL ANDA 28 sections
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE HUMAN PRESCRIPTION DRUG LABEL 2 45802-066 SPRAY, METERED 137 ug NASAL ANDA 28 sections
Azelastine Hydrochloride Human Prescription Drug Label 1 47335-779 SPRAY, METERED 137 ug NASAL ANDA 25 sections
Azelastine Hydrochloride Human Prescription Drug Label 1 47335-938 SOLUTION/ DROPS 0.50 mg INTRAOCULAR ANDA 17 sections
Azelastine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-2330 SPRAY, METERED 137 ug NASAL ANDA 19 sections
Azelastine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-2330 SPRAY, METERED 137 ug NASAL ANDA 19 sections
Azelastine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-3833 SPRAY, METERED 1 mg NASAL ANDA 27 sections
Azelastine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50383-738 SPRAY, METERED 1 mg NASAL ANDA 25 sections
Azelastine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50383-942 SPRAY, METERED 1.50 mg NASAL ANDA 25 sections
Azelastine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50383-942 SPRAY, METERED 1.50 mg NASAL ANDA 25 sections
AZELASTINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 51991-814 SPRAY, METERED 137 ug NASAL ANDA 28 sections
AZELASTINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 51991-814 SPRAY, METERED 137 ug NASAL ANDA 28 sections
Azelastine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 53002-1279 SPRAY, METERED 137 ug NASAL ANDA 19 sections
Azelastine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 53002-1279 SPRAY, METERED 137 ug NASAL ANDA 19 sections
Azelastine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 53002-1803 SOLUTION/ DROPS 0.50 mg INTRAOCULAR ANDA 16 sections
Azelastine Hydrochloride Human Prescription Drug Label 1 53002-2279 SPRAY, METERED 137 ug NASAL ANDA 25 sections
AZELASTINE HYDROCHLORIDE Human Prescription Drug Label 1 53002-5279 SPRAY, METERED 137 ug NASAL ANDA 26 sections