olopatadine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
histamine-H1 receptor antagonists, tricyclic compounds 1986 113806-05-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • olopatadine
  • olopatadine hydrochloride
  • opatanol
  • pataday
  • patanol
  • olopatadine HCl
An antihistamine with mast-cell stabilizing properties used as eye drops in the treatment of ALLERGIC CONJUNCTIVITIS.
  • Molecular weight: 337.42
  • Formula: C21H23NO3
  • CLOGP: 1.09
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 49.77
  • ALOGS: -4.03
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 28.04 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 65 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.11 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,EGFR,EIF2AK3,ERBB2,GRK2,ITK,MAP2K6,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PIK3CB,PRKDC,TEK,TGFBR1 22
kinase-selectivity-class AXL,BRAF,EIF2AK3,MAP2K6 4
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 3.926 Moderate 0.65
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 Moderate 0.65
rat-kpuu-brain Rat brain Kpuu 0.022 % Moderate 0.65

Approvals:

DateAgencyCompanyOrphan
Dec. 18, 1996 FDA ALCON

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 1289.04 13.72 704 12805 303224 90311714
Eye irritation 135.09 13.72 76 13433 33902 90581036
Eye pruritus 91.82 13.72 56 13453 28971 90585967
Asthma 60.52 13.72 120 13389 242040 90372898
Conjunctivitis allergic 58.86 13.72 17 13492 1315 90613623
Dry eye 57.41 13.72 56 13453 57875 90557063
Eye discharge 54.56 13.72 26 13483 8232 90606706
Ocular hyperaemia 52.16 13.72 42 13467 33756 90581182
Urticarial vasculitis 44.68 13.72 13 13496 1032 90613906
Vision blurred 40.88 13.72 65 13444 110228 90504710
Systemic lupus erythematosus 39.63 13.72 4 13505 361892 90253046
Maternal exposure during pregnancy 39.38 13.72 4 13505 360059 90254879
Eyelid margin crusting 37.92 13.72 13 13496 1759 90613179
Drug intolerance 37.86 13.72 10 13499 447581 90167357
Total cholesterol/HDL ratio abnormal 37.30 13.72 7 13502 77 90614861
Contraindicated product administered 36.49 13.72 3 13506 320136 90294802
Dry skin 35.56 13.72 54 13455 88019 90526919
Synovitis 35.19 13.72 4 13505 329748 90285190
Glossodynia 34.10 13.72 4 13505 321775 90293163
Hepatic function abnormal 33.77 13.72 38 13471 46250 90568688
Sinusitis 32.81 13.72 119 13390 342969 90271969
Dermatitis atopic 31.69 13.72 27 13482 23445 90591493
Arthropathy 31.31 13.72 8 13501 366234 90248704
Impaired quality of life 29.98 13.72 26 13483 23118 90591820
Toxicity to various agents 29.47 13.72 4 13505 287842 90327096
Upper respiratory tract inflammation 29.27 13.72 12 13497 2660 90612278
Bronchitis 29.19 13.72 68 13441 152859 90462079
Drug eruption 29.19 13.72 31 13478 35376 90579562
Eye pain 28.43 13.72 34 13475 44134 90570804
Eczema 28.13 13.72 37 13472 52833 90562105
Lower respiratory tract infection 26.84 13.72 3 13506 250656 90364282
Eye allergy 25.64 13.72 9 13500 1306 90613632
Alopecia areata 25.36 13.72 10 13499 2005 90612933
Conjunctivitis 24.93 13.72 25 13484 26681 90588257
General physical health deterioration 24.72 13.72 11 13498 355104 90259834
Eye swelling 24.70 13.72 26 13483 29360 90585578
Product delivery mechanism issue 24.66 13.72 7 13502 509 90614429
Seasonal allergy 24.24 13.72 23 13486 22960 90591978
Renal colic 23.63 13.72 9 13500 1644 90613294
Illness 23.36 13.72 43 13466 81926 90533012
Cold urticaria 23.32 13.72 6 13503 300 90614638
Urticaria aquagenic 22.25 13.72 4 13505 34 90614904
Cough 22.06 13.72 111 13398 368851 90246087
Urticaria cholinergic 21.75 13.72 4 13505 39 90614899
Wound 21.69 13.72 9 13500 302971 90311967
Helicobacter infection 21.31 13.72 4 13505 226846 90388092
Allergy to arthropod bite 20.77 13.72 6 13503 464 90614474
Infusion related reaction 20.69 13.72 19 13490 416761 90198177
Mobility decreased 20.44 13.72 6 13503 250728 90364210
Product packaging quantity issue 20.33 13.72 8 13501 1594 90613344
Lichenification 20.19 13.72 6 13503 513 90614425
Rheumatoid arthritis 19.88 13.72 15 13494 362599 90252339
Hepatic enzyme increased 19.68 13.72 15 13494 360721 90254217
Hypohidrosis 19.43 13.72 4 13505 73 90614865
Lacrimation increased 19.37 13.72 22 13487 27040 90587898
Neutrophil count decreased 18.49 13.72 36 13473 71496 90543442
Nasal congestion 18.04 13.72 39 13470 83375 90531563
Productive cough 17.79 13.72 37 13472 77026 90537912
Foreign body sensation in eyes 17.66 13.72 9 13500 3291 90611647
Burning feet syndrome 17.46 13.72 4 13505 122 90614816
Dust allergy 17.42 13.72 6 13503 823 90614115
Xerosis 17.28 13.72 7 13502 1504 90613434
Rhinorrhoea 16.55 13.72 39 13470 88277 90526661
Folliculitis 16.45 13.72 5 13504 204348 90410590
Homicidal ideation 16.18 13.72 7 13502 1773 90613165
Vein collapse 15.58 13.72 6 13503 1130 90613808
Myofascial pain syndrome 15.51 13.72 8 13501 2999 90611939
Gastrointestinal disorder 14.87 13.72 10 13499 256677 90358261
Adrenal insufficiency 14.48 13.72 20 13489 29901 90585037
Ear discomfort 14.32 13.72 12 13497 10188 90604750
Product dose omission issue 14.20 13.72 83 13426 291604 90323334
Ill-defined disorder 14.04 13.72 5 13504 184886 90430052

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 648.69 17.88 264 5715 62360 42552996
Hypersensitivity 97.79 17.88 81 5898 72289 42543067
Eye irritation 90.78 17.88 40 5939 11278 42604078
Ocular hyperaemia 63.55 17.88 35 5944 15928 42599428
Dry eye 53.61 17.88 31 5948 15475 42599881
Cardiac disorder 52.36 17.88 48 5931 48884 42566472
Dermatitis atopic 46.10 17.88 26 5953 12378 42602978
Asthma 44.34 17.88 49 5930 62265 42553091
Eye discharge 39.07 17.88 15 5964 2980 42612376
Pruritus 36.29 17.88 81 5898 188690 42426666
Hepatic function abnormal 35.73 17.88 40 5939 51527 42563829
Cerebral infarction 32.20 17.88 30 5949 31139 42584217
Eye pruritus 32.13 17.88 20 5959 11392 42603964
Product delivery mechanism issue 29.68 17.88 7 5972 259 42615097
Eye pain 29.27 17.88 22 5957 17008 42598348
Rash 28.16 17.88 94 5885 276860 42338496
Alopecia areata 27.77 17.88 7 5972 343 42615013
Interstitial lung disease 26.69 17.88 43 5936 78419 42536937
Sinusitis 26.63 17.88 33 5946 47259 42568097
Drug eruption 23.43 17.88 22 5957 23053 42592303
Eye allergy 22.79 17.88 5 5974 133 42615223
Lacrimation increased 22.02 17.88 16 5963 11742 42603614
Erythema multiforme 19.65 17.88 14 5965 9963 42605393

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
Asthma 81.45 13.48 132 14879 250159 110324129
Eye irritation 76.97 13.48 51 14960 33401 110540887
Hepatic function abnormal 66.75 13.48 71 14940 89224 110485064
Eye pruritus 63.64 13.48 45 14966 32730 110541558
Cardiac disorder 61.21 13.48 63 14948 76217 110498071
Dermatitis atopic 58.90 13.48 39 14972 25502 110548786
Ocular hyperaemia 58.51 13.48 46 14965 39240 110535048
Dry eye 55.82 13.48 52 14959 55741 110518547
Drug eruption 51.75 13.48 49 14962 53610 110520678
Alopecia areata 48.10 13.48 16 14995 2171 110572117
Eye discharge 43.41 13.48 22 14989 8732 110565556
Conjunctivitis allergic 39.06 13.48 19 14992 6912 110567376
Drug intolerance 38.26 13.48 5 15006 406507 110167781
Total cholesterol/HDL ratio abnormal 37.87 13.48 7 15004 78 110574210
Upper respiratory tract inflammation 37.32 13.48 16 14995 4355 110569933
Dry skin 36.63 13.48 58 14953 107595 110466693
Neutrophil count decreased 35.55 13.48 61 14950 120880 110453408
Cerebral infarction 34.86 13.48 39 14972 51799 110522489
Urticarial vasculitis 33.27 13.48 10 15001 976 110573312
Interstitial lung disease 33 13.48 64 14947 139270 110435018
Platelet count decreased 31.35 13.48 85 14926 230358 110343930
Adrenal insufficiency 28.68 13.48 32 14979 42358 110531930
Erythema multiforme 27.80 13.48 23 14988 21074 110553214
Sinusitis 26.90 13.48 95 14916 296593 110277695
Synovitis 26.69 13.48 3 15008 274089 110300199
Eye pain 25.95 13.48 33 14978 50066 110524222
Lacrimation increased 25.61 13.48 26 14985 30924 110543364
Pruritus 25.40 13.48 150 14861 581410 109992878
Treatment failure 24.70 13.48 4 15007 277230 110297058
Impaired quality of life 24.44 13.48 25 14986 29992 110544296
Maternal exposure during pregnancy 24.30 13.48 3 15008 254880 110319408
Giant papillary conjunctivitis 24.29 13.48 4 15007 21 110574267
Blepharitis 24.22 13.48 12 14999 4540 110569748
Conjunctivitis 23.71 13.48 26 14985 33766 110540522
Hypersensitivity 23.65 13.48 113 14898 403885 110170403
Bronchitis 23.46 13.48 60 14951 156972 110417316
Eczema 23.29 13.48 38 14973 72255 110502033
Seasonal allergy 22.91 13.48 20 14991 19702 110554586
Lower respiratory tract infection 22.84 13.48 3 15008 243103 110331185
Eyelid margin crusting 22.72 13.48 9 15002 2007 110572281
Urticaria aquagenic 22.52 13.48 4 15007 35 110574253
Concomitant disease aggravated 21.89 13.48 18 14993 16346 110557942
Allergy to arthropod bite 21.68 13.48 6 15005 437 110573851
Rash 21.43 13.48 187 14824 820777 109753511
Corneal erosion 21.22 13.48 6 15005 473 110573815
Lichenification 20.68 13.48 7 15004 1002 110573286
Anaphylactic reaction 20.64 13.48 47 14964 114253 110460035
Erythema 20.41 13.48 86 14925 291361 110282927
Eye allergy 20.35 13.48 7 15004 1052 110573236
Urticaria cholinergic 20.12 13.48 4 15007 67 110574221
Pyrexia 20.12 13.48 198 14813 898067 109676221
Arthropathy 20.03 13.48 7 15004 287515 110286773
Urticaria 19.98 13.48 91 14920 318766 110255522
Systemic lupus erythematosus 19.89 13.48 5 15006 254333 110319955
Off label use 19.88 13.48 121 14890 1500064 109074224
Contraindicated product administered 19.19 13.48 5 15006 248262 110326026
Pharyngitis 18.82 13.48 20 14991 25078 110549210
General physical health deterioration 18.80 13.48 18 14993 425277 110149011
Hypohidrosis 18.68 13.48 5 15006 321 110573967
Renal colic 18.56 13.48 9 15002 3249 110571039
Completed suicide 18.51 13.48 5 15006 242376 110331912
Glossodynia 18.08 13.48 4 15007 222000 110352288
Skin exfoliation 18.05 13.48 38 14973 87613 110486675
Pericarditis 17.74 13.48 4 15007 219110 110355178
Productive cough 17.41 13.48 44 14967 114261 110460027
Myofascial pain syndrome 17.40 13.48 8 15003 2565 110571723
Cataract cortical 16.86 13.48 4 15007 157 110574131
Cough 16.38 13.48 113 14898 461528 110112760
Ocular surface disease 16.33 13.48 4 15007 180 110574108
Allergy to animal 16.31 13.48 7 15004 1909 110572379
Vein collapse 15.31 13.48 6 15005 1301 110572987
Nasal congestion 15.14 13.48 38 14973 98244 110476044
Rhinorrhoea 15.09 13.48 39 14972 102627 110471661
Burning feet syndrome 15.03 13.48 4 15007 251 110574037
Corynebacterium sepsis 15.02 13.48 4 15007 252 110574036
Cold urticaria 14.97 13.48 4 15007 255 110574033
Tricuspid valve thickening 14.94 13.48 3 15008 53 110574235
Rhinitis allergic 14.72 13.48 15 14996 17907 110556381
Oropharyngeal pain 14.63 13.48 46 14965 135230 110439058
Mobility decreased 14.56 13.48 7 15004 237415 110336873
Cornea verticillata 14.14 13.48 4 15007 316 110573972
Rheumatoid arthritis 14.05 13.48 12 14999 299601 110274687
Illness 13.97 13.48 33 14978 82138 110492150
Xerosis 13.96 13.48 6 15005 1643 110572645
Corneal scar 13.87 13.48 4 15007 338 110573950
Disseminated intravascular coagulation 13.70 13.48 22 14989 41264 110533024
Hyperuricaemia 13.49 13.48 13 14998 14518 110559770

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R01AC08 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Antiallergic agents, excl. corticosteroids
ATC S01GX09 SENSORY ORGANS
OPHTHALMOLOGICALS
DECONGESTANTS AND ANTIALLERGICS
Other antiallergics
FDA MoA N0000000190 Histamine H1 Receptor Antagonists
FDA EPC N0000175519 Histamine-1 Receptor Inhibitor
MeSH PA D000700 Analgesics
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018501 Antirheumatic Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D039563 Histamine H1 Antagonists, Non-Sedating
FDA EPC N0000175587 Histamine-1 Receptor Antagonist
FDA PE N0000175628 Decreased Histamine Release
FDA EPC N0000175630 Mast Cell Stabilizer
CHEBI has role CHEBI:66981 ophthalmology drug

Related Drugs by ATC class:

R01AC Antiallergic agents, excl. corticosteroids 7 drugs
S01GX Other antiallergics 12 drugs

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

DiseaseRelationSNOMED_IDDOID
Allergic rhinitis indication 61582004
Seasonal allergic rhinitis indication 367498001
Allergic conjunctivitis indication 473460002 DOID:11204
Epistaxis contraindication 12441001
Perforation of nasal septum contraindication 80142000
Nasal Lesions contraindication
Nasal Septal Ulcers contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.89 acidic
pKa2 8.66 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 0.7% BASE PATADAY ONCE DAILY RELIEF ALCON LABS INC N206276 Jan. 30, 2015 OTC SOLUTION/DROPS OPHTHALMIC 8791154 May 19, 2032 TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECLT N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10016443 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECLT N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10517880 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECLT N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10548907 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECLT N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10646500 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECLT N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10758550 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE TO A PEDIATRIC PATIENT
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECLT N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10765686 Sept. 4, 2034 METHOD OF DELIVERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE TO A NASAL AIRWAY
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECLT N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 11400101 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECLT N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 12064442 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECLT N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 9078923 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECLT N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 9750754 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE

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 8.28 WOMBAT-PK CHEMBL
Histamine H1 receptor GPCR Ki 7.80 CHEMBL

External reference:

IDSource
4021024 VUID
N0000148491 NUI
D01192 KEGG_DRUG
140462-76-6 SECONDARY_CAS_RN
4021024 VANDF
4021040 VANDF
C0527189 UMLSCUI
CHEBI:7769 CHEBI
CHEMBL1189432 ChEMBL_ID
CHEMBL1719 ChEMBL_ID
DB00768 DRUGBANK_ID
D000069605 MESH_DESCRIPTOR_UI
5281071 PUBCHEM_CID
7249 IUPHAR_LIGAND_ID
7257 INN_ID
D27V6190PM UNII
135391 RXNORM
10342 MMSL
107496 MMSL
230004 MMSL
5199 MMSL
006403 NDDF
006404 NDDF
108843008 SNOMEDCT_US
108845001 SNOMEDCT_US
372550002 SNOMEDCT_US
D27V6190PM INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
PATADAY ONCE DAILY RELIEF HUMAN OTC DRUG LABEL 1 0065-0816 SOLUTION 7 mg OPHTHALMIC NDA 12 sections
PATADAY TWICE A DAY RELIEF HUMAN OTC DRUG LABEL 1 0065-4274 SOLUTION 1 mg OPHTHALMIC NDA 12 sections
PATADAY ONCE DAILY RELIEF HUMAN OTC DRUG LABEL 1 0065-8150 SOLUTION 2 mg OPHTHALMIC NDA 12 sections
OLOPATADINE HYDROCHLORIDE Human OTC Drug Label 1 0363-0200 SOLUTION 1 mg OPHTHALMIC ANDA 13 sections
Olopatadine Hydrochloride Ophthalmic Solution HUMAN OTC DRUG LABEL 1 0363-0867 SOLUTION 1 mg OPHTHALMIC ANDA 8 sections
OLOPATADINE HYDROCHLORIDE HUMAN OTC DRUG LABEL 1 0363-0869 SOLUTION 2 mg OPHTHALMIC ANDA 8 sections
Eye Allergy Itch Relief Human OTC Drug Label 1 0363-1325 SOLUTION 7 mg OPHTHALMIC ANDA 14 sections
Olopatadine Hydrochloride Ophthalmic Solution Human OTC Drug Label 1 0363-7130 SOLUTION/ DROPS 1 mg OPHTHALMIC ANDA 14 sections
Olopatadine Hydrochloride Ophthalmic Solution Human OTC Drug Label 1 0363-7131 SOLUTION 2 mg OPHTHALMIC ANDA 12 sections
OLOPATADINE HYDROCHLORIDE Human OTC Drug Label 1 0363-8022 SOLUTION 2 mg OPHTHALMIC ANDA 13 sections
Olopatadine Hydrochloride Human OTC Drug Label 1 0536-1307 SOLUTION/ DROPS 2 mg OPHTHALMIC ANDA 11 sections
Olopatadine Hydrochloride HUMAN OTC DRUG LABEL 1 0536-1445 SOLUTION/ DROPS 1 mg OPHTHALMIC ANDA 11 sections
Olopatadine HCl Human OTC Drug Label 1 0536-1478 SOLUTION/ DROPS 7 mg OPHTHALMIC ANDA 14 sections
Olopatadine Hydrochloride Ophthalmic Solution Human OTC Drug Label 1 11673-688 SOLUTION 2 mg OPHTHALMIC ANDA 11 sections
Olopatadine Hydrochloride Ophthalmic Solution Human OTC Drug Label 1 11673-689 SOLUTION/ DROPS 1 mg OPHTHALMIC ANDA 13 sections
OLOPATADINE HYDROCHLORIDE Human OTC Drug Label 1 11822-0063 SOLUTION 2 mg OPHTHALMIC ANDA 13 sections
OLOPATADINE HYDROCHLORIDE Human OTC Drug Label 1 11822-0064 SOLUTION 1 mg OPHTHALMIC ANDA 13 sections
Olopatadine Hydrochloride Ophthalmic Solution Human OTC Drug Label 1 11822-9975 SOLUTION 2 mg OPHTHALMIC ANDA 11 sections
Olopatadine Hydrochloride Ophthalmic Solution Human OTC Drug Label 1 11822-9976 SOLUTION/ DROPS 1 mg OPHTHALMIC ANDA 13 sections
olopatadine hydrochloride Human OTC Drug Label 1 16571-861 SOLUTION 2 mg OPHTHALMIC ANDA 12 sections
olopatadine hydrochloride Human OTC Drug Label 1 16571-882 SOLUTION 1 mg OPHTHALMIC ANDA 12 sections
Olopatadine HUMAN PRESCRIPTION DRUG LABEL 1 17478-105 SOLUTION/ DROPS 1 mg OPHTHALMIC ANDA 17 sections
Olopatadine HUMAN PRESCRIPTION DRUG LABEL 1 17478-305 SOLUTION/ DROPS 2 mg OPHTHALMIC ANDA 24 sections
Olopatadine HUMAN PRESCRIPTION DRUG LABEL 1 17478-305 SOLUTION/ DROPS 2 mg OPHTHALMIC ANDA 24 sections
Olopatadine HUMAN OTC DRUG LABEL 1 17478-308 SOLUTION/ DROPS 1 mg OPHTHALMIC ANDA 13 sections
Olopatadine HUMAN OTC DRUG LABEL 1 17478-312 SOLUTION/ DROPS 2 mg OPHTHALMIC ANDA 13 sections
Olopatadine Hydrochloride Ophthalmic Solution Human OTC Drug Label 1 21130-105 SOLUTION 2 mg OPHTHALMIC ANDA 12 sections
OLOPATADINE HYDROCHLORIDE HUMAN OTC DRUG LABEL 1 24208-617 SOLUTION 2 mg OPHTHALMIC ANDA 9 sections
Olopatadine Hydrochloride Ophthalmic Solution HUMAN OTC DRUG LABEL 1 24208-966 SOLUTION 1 mg OPHTHALMIC ANDA 11 sections
OLOPATADINE HYDROCHLORIDE HUMAN OTC DRUG LABEL 1 24208-967 SOLUTION 2 mg OPHTHALMIC ANDA 13 sections