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 |
|---|---|
|
Synonyms:
|
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.
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 | 339.96 | 15.22 | 252 | 9696 | 137385 | 50457791 |
| Sinusitis | 143.74 | 15.22 | 172 | 9776 | 170386 | 50424790 |
| Product dose omission issue | 59.31 | 15.22 | 119 | 9829 | 183719 | 50411457 |
| Asthma | 59.06 | 15.22 | 80 | 9868 | 89257 | 50505919 |
| Infusion site swelling | 45.45 | 15.22 | 24 | 9924 | 7152 | 50588024 |
| Headache | 44.65 | 15.22 | 207 | 9741 | 506328 | 50088848 |
| Infusion site erythema | 43.72 | 15.22 | 25 | 9923 | 8702 | 50586474 |
| Bronchitis | 33.01 | 15.22 | 67 | 9881 | 104092 | 50491084 |
| Toxicity to various agents | 30.95 | 15.22 | 3 | 9945 | 212496 | 50382680 |
| Sinus disorder | 30.85 | 15.22 | 27 | 9921 | 18431 | 50576745 |
| Cough | 30.17 | 15.22 | 110 | 9838 | 241154 | 50354022 |
| Infusion site extravasation | 27.18 | 15.22 | 17 | 9931 | 6959 | 50588217 |
| COVID-19 | 23.82 | 15.22 | 37 | 9911 | 46625 | 50548551 |
| Infusion site pain | 22.54 | 15.22 | 19 | 9929 | 12327 | 50582849 |
| Pre-existing condition improved | 22.03 | 15.22 | 15 | 9933 | 7082 | 50588094 |
| Multiple allergies | 21.89 | 15.22 | 16 | 9932 | 8447 | 50586729 |
| Nasal discomfort | 21.77 | 15.22 | 12 | 9936 | 3892 | 50591284 |
| Infusion site pruritus | 21.67 | 15.22 | 12 | 9936 | 3925 | 50591251 |
| Fatigue | 20.29 | 15.22 | 220 | 9728 | 707381 | 49887795 |
| Infusion site haemorrhage | 18.89 | 15.22 | 10 | 9938 | 2994 | 50592182 |
| Systemic lupus erythematosus | 18.01 | 15.22 | 3 | 9945 | 140619 | 50454557 |
| Product quality issue | 17.93 | 15.22 | 26 | 9922 | 30832 | 50564344 |
| Product taste abnormal | 17.54 | 15.22 | 8 | 9940 | 1737 | 50593439 |
| Hepatic enzyme increased | 17.44 | 15.22 | 3 | 9945 | 137377 | 50457799 |
| Upper respiratory tract infection | 16.97 | 15.22 | 39 | 9909 | 65859 | 50529317 |
| Ear infection | 16.74 | 15.22 | 23 | 9925 | 25947 | 50569229 |
| Sleep apnoea syndrome | 16.70 | 15.22 | 22 | 9926 | 23846 | 50571330 |
| Therapy interrupted | 16.36 | 15.22 | 20 | 9928 | 20132 | 50575044 |
| Nasal congestion | 16.31 | 15.22 | 33 | 9915 | 51087 | 50544089 |
| General physical health deterioration | 16.25 | 15.22 | 4 | 9944 | 142430 | 50452746 |
| Drug intolerance | 15.79 | 15.22 | 12 | 9936 | 219092 | 50376084 |
| Upper-airway cough syndrome | 15.28 | 15.22 | 13 | 9935 | 8537 | 50586639 |
| Choroidal effusion | 15.22 | 15.22 | 5 | 9943 | 449 | 50594727 |
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 | 250.98 | 18.87 | 116 | 4043 | 36823 | 29533545 |
| Sinusitis | 69.59 | 18.87 | 49 | 4110 | 34301 | 29536067 |
| Transferrin increased | 35.89 | 18.87 | 5 | 4154 | 5 | 29570363 |
| Chorioretinopathy | 33.34 | 18.87 | 11 | 4148 | 1405 | 29568963 |
| Oesophageal injury | 30.40 | 18.87 | 5 | 4154 | 25 | 29570343 |
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 | 81.25 | 14.78 | 106 | 9826 | 145822 | 64342978 |
| Asthma | 49.60 | 14.78 | 67 | 9865 | 95158 | 64393642 |
| Product dose omission issue | 47.08 | 14.78 | 97 | 9835 | 194650 | 64294150 |
| Headache | 44.58 | 14.78 | 180 | 9752 | 529287 | 63959513 |
| Toxicity to various agents | 44.34 | 14.78 | 3 | 9929 | 363510 | 64125290 |
| Fatigue | 31.67 | 14.78 | 210 | 9722 | 748520 | 63740280 |
| Transferrin increased | 29.94 | 14.78 | 5 | 9927 | 25 | 64488775 |
| Chorioretinopathy | 27.64 | 14.78 | 11 | 9921 | 2186 | 64486614 |
| Cough | 25.54 | 14.78 | 103 | 9829 | 302045 | 64186755 |
| Oesophageal injury | 25.17 | 14.78 | 5 | 9927 | 73 | 64488727 |
| Product quality issue | 23.71 | 14.78 | 26 | 9906 | 29773 | 64459027 |
| Infusion site erythema | 23.22 | 14.78 | 14 | 9918 | 6859 | 64481941 |
| Bronchitis | 22.60 | 14.78 | 51 | 9881 | 108692 | 64380108 |
| General physical health deterioration | 21.47 | 14.78 | 3 | 9929 | 204422 | 64284378 |
| Sinus disorder | 21.38 | 14.78 | 19 | 9913 | 16889 | 64471911 |
| Infusion site swelling | 20.74 | 14.78 | 12 | 9920 | 5453 | 64483347 |
| Acute respiratory failure | 19.94 | 14.78 | 31 | 9901 | 49903 | 64438897 |
| Upper-airway cough syndrome | 17.80 | 14.78 | 13 | 9919 | 8757 | 64480043 |
| Therapy interrupted | 16.84 | 14.78 | 18 | 9914 | 20018 | 64468782 |
| Nasal operation | 16.07 | 14.78 | 4 | 9928 | 169 | 64488631 |
| Dermatitis atopic | 16.02 | 14.78 | 9 | 9923 | 3867 | 64484933 |
| Infusion site pain | 15.83 | 14.78 | 13 | 9919 | 10384 | 64478416 |
| Flushing | 15.36 | 14.78 | 36 | 9896 | 78612 | 64410188 |
| Drug interaction | 15.32 | 14.78 | 20 | 9912 | 362063 | 64126737 |
| Psoriasis | 15.31 | 14.78 | 34 | 9898 | 71669 | 64417131 |
| Dyspnoea | 15.16 | 14.78 | 173 | 9759 | 718501 | 63770299 |
| Nasal discomfort | 15.10 | 14.78 | 9 | 9923 | 4319 | 64484481 |
| Choroidal effusion | 14.95 | 14.78 | 5 | 9927 | 607 | 64488193 |
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 | 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]) | Mechanism action | Bioact source | MoA 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:
| 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 |
| 003931 | NDDF |
| 003932 | NDDF |
| 4021001 | VANDF |
| 4024042 | VANDF |
| 108644000 | SNOMEDCT_US |
| 108646003 | SNOMEDCT_US |
| 372520005 | SNOMEDCT_US |
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 | 28 sections |
| Azelastine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0293 | SPRAY, METERED | 137 ug | NASAL | ANDA | 27 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 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 | 50090-3833 | 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 | 53002-1279 | SPRAY, METERED | 137 ug | NASAL | ANDA | 19 sections |
| Azelastine Hydrochloride | Human Prescription Drug Label | 1 | 53002-2279 | SPRAY, METERED | 137 ug | NASAL | ANDA | 25 sections |
| Astelin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-5072 | SPRAY, METERED | 137 ug | NASAL | NDA | 22 sections |
| Azelastine Hydrochloride | Human prescription drug label | 1 | 54868-6131 | SPRAY, METERED | 137 ug | NASAL | ANDA | 19 sections |
| AZELASTINE HYDROCHLORIDE | Human Prescription Drug Label | 1 | 59651-214 | SPRAY, METERED | 137 ug | NASAL | ANDA | 26 sections |
| AZELASTINE HYDROCHLORIDE | Human Prescription Drug Label | 1 | 59651-214 | SPRAY, METERED | 137 ug | NASAL | ANDA | 26 sections |
| AZELASTINE HYDROCHLORIDE | Human Prescription Drug Label | 1 | 59651-215 | SPRAY, METERED | 205.50 ug | NASAL | ANDA | 26 sections |
| AZELASTINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-0578 | SOLUTION/ DROPS | 0.50 mg | INTRAOCULAR | ANDA | 17 sections |
| Azelastine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-0833 | SPRAY, METERED | 137 ug | NASAL | ANDA | 19 sections |
| Azelastine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-0848 | SPRAY, METERED | 205.50 ug | NASAL | ANDA | 26 sections |
| Azelastine hydrochloride and Fluticasone propionate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 60505-0953 | SPRAY, METERED | 137 ug | NASAL | ANDA | 27 sections |
| Azelastine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61314-308 | SOLUTION/ DROPS | 0.50 mg | INTRAOCULAR | ANDA | 16 sections |
| Azelastine Hydrochloride Ophthalmic Solution 0.05% | Human Prescription Drug Label | 1 | 62332-506 | SOLUTION/ DROPS | 0.50 mg | OPHTHALMIC | ANDA | 16 sections |
| Azelastine Hydrochloride Ophthalmic Solution 0.05% | Human Prescription Drug Label | 1 | 62332-506 | SOLUTION/ DROPS | 0.50 mg | OPHTHALMIC | ANDA | 16 sections |