azelastine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antihistaminics	271	58581-89-8

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
0.56	mg	N
4	mg	O

ADMET properties:

Property	Value	Reference
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 µM/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:

Date	Agency	Company	Orphan
Nov. 1, 1996	FDA	MEDA PHARMS

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
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 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
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 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
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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.91	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
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Histamine H1 receptor	GPCR	P35367	HRH1_HUMAN	ANTAGONIST	Ki	8.17	WOMBAT-PK	CHEMBL
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN				WOMBAT-PK
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		Ki	7.70	CHEMBL
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN		Ki	6.30	CHEMBL
Alpha-1A adrenergic receptor	GPCR	P35348	ADA1A_HUMAN		Ki	7.30	CHEMBL
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		IC50	5.20	CHEMBL
Alpha-1B adrenergic receptor	GPCR	P35368	ADA1B_HUMAN		Ki	7.30	CHEMBL
Histamine H3 receptor	GPCR	Q9Y5N1	HRH3_HUMAN		Ki	6.83	CHEMBL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	7	CHEMBL
Alpha-1A adrenergic receptor	GPCR		ADA1A_RAT		Ki	7.30	CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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