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1. 11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic Acid
2. 4679, Kw
3. Hydrochloride, Olopatadine
4. Kw 4679
5. Kw 4943a
6. Kw-4679
7. Kw-4943a
8. Kw4943a
9. Olopatadine
10. Patanol
1. 140462-76-6
2. Olopatadine Hcl
3. Allelock
4. Pataday
5. Patanase
6. Alo4943a
7. Pazeo
8. Kw4679
9. Kw-4679
10. Olopatadine (hydrochloride)
11. Alo-4943a
12. (z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)acetic Acid Hydrochloride
13. Olopatadine (as Hydrochloride)
14. 2xg66w44kf
15. Dsstox_cid_26486
16. Dsstox_rid_81657
17. Dsstox_gsid_46486
18. Dibenz(b,e)oxepin-2-acetic Acid, 11-(3-(dimethylamino)propylidene)-6,11-dihydro-, Hydrochloride, (z)-
19. Olopine
20. Patadine
21. Olopax
22. Chembl1719
23. Kw 4679
24. Cas-140462-76-6
25. Opatanol (tn)
26. Unii-2xg66w44kf
27. Sr-01000763388
28. Alo 4943a
29. Olopatadine Hydrochloride [usan]
30. Allelock (tn)
31. Patanol (tn)
32. De 114
33. Mfcd00875716
34. Olopatadine Hydrochloride [usan:usp]
35. Olopatadine Hydrochlorde
36. O-ppds
37. Ncgc00164623-01
38. Schembl23213
39. Mls001401465
40. Dtxsid0046486
41. Chebi:31933
42. Hy-b0426a
43. Olopatadine Hydrochloride- Bio-x
44. Al4943a
45. Alo4943a;kw4679
46. 2-[(11z)-11-[3-(dimethylamino)propylidene]-6h-benzo[c][1]benzoxepin-2-yl]acetic Acid;hydrochloride
47. Dibenz[b,e]oxepin-2-acetic Acid, 11-[3-(dimethylamino)propylidene]-6,11-dihydro-, Hydrochloride (1:1), (11z)-
48. Ex-a1347
49. Olopatadine Hydrochloride (opatanol)
50. Tox21_112242
51. S2494
52. Olopatadine Hydrochloride [mi]
53. Akos015895232
54. Akos025149118
55. Olopatadine Hydrochloride (jp17/usp)
56. Tox21_112242_1
57. Bcp9001022
58. Ccg-101141
59. H06o056
60. Ks-1228
61. Nc00391
62. Olopatadine Hydrochloride [jan]
63. Ncgc00263532-01
64. Olopatadine Hydrochloride [mart.]
65. Olopatadine Hydrochloride [vandf]
66. 11-((z)-3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic Acid Hydrochloride
67. 11-((z)-3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic Acid, Hydrochloride
68. Bo164171
69. Dibenz(b,e)oxepin-2-acetic Acid, 11-(3-dimethylamino)propylidene)-6,11-dihydro-, Hydrochloride, (z)-
70. Olopatadine Hydrochloride [usp-rs]
71. Olopatadine Hydrochloride [who-dd]
72. Smr000469220
73. Olopatadine Hydrochloride, >=98% (hplc)
74. Olopatadine Hydrochloride [ema Epar]
75. O0361
76. C72607
77. D01192
78. Olopatadine Hydrochloride [orange Book]
79. Olopatadine Hydrochloride [usp Monograph]
80. A807652
81. Ryaltris Component Olopatadine Hydrochloride
82. Q-201511
83. Sr-01000763388-4
84. Olopatadine Hydrochloride Component Of Ryaltris
85. Q27255766
86. Olopatadine Hydrochloride, United States Pharmacopeia (usp) Reference Standard
87. (z)-11-[3-(dimethylamino)propylidene]-6,11-dihydro-dibenz[b,e]oxepin-2-acetic Acid Hydrochloride
88. (z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)aceticacidhydrochloride
| Molecular Weight | 373.9 g/mol |
|---|---|
| Molecular Formula | C21H24ClNO3 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 5 |
| Exact Mass | 373.1444713 g/mol |
| Monoisotopic Mass | 373.1444713 g/mol |
| Topological Polar Surface Area | 49.8 Ų |
| Heavy Atom Count | 26 |
| Formal Charge | 0 |
| Complexity | 488 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 8 | |
|---|---|
| Drug Name | Olopatadine hydrochloride |
| Drug Label | Olopatadine Hydrochloride Nasal Solution (Nasal Spray), 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of Olopatadine Hydrochloride Nasal Solution (Nasal Spray), is a wh... |
| Active Ingredient | Olopatadine hydrochloride |
| Dosage Form | Solution/drops; Spray, metered; Solution |
| Route | Ophthalmic; Nasal; ophthalmic |
| Strength | 0.665mg/spray; 0.2% base; 0.1%; eq 0.1% base; 0.2% |
| Market Status | Tentative Approval; Prescription |
| Company | Wockhardt; Apotex; Sandoz; Watson Labs; Barr |
| 2 of 8 | |
|---|---|
| Drug Name | Pataday |
| Drug Label | PATADAY (olopatadine hydrochloride ophthalmic solution) 0.2% is a sterile ophthalmic solution containing olopatadine for topical administration to the eyes.Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular we... |
| Active Ingredient | Olopatadine hydrochloride |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.2% base |
| Market Status | Prescription |
| Company | Alcon Pharms |
| 3 of 8 | |
|---|---|
| Drug Name | Patanase |
| PubMed Health | Olopatadine (Into the nose) |
| Drug Classes | Nasal Agent |
| Drug Label | PATANASE (olopatadine hydrochloride) Nasal Spray, 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of PATANASE Nasal Spray, is a white, water-soluble crystalline powder. T... |
| Active Ingredient | Olopatadine hydrochloride |
| Dosage Form | Spray, metered |
| Route | Nasal |
| Strength | 0.665mg/spray |
| Market Status | Prescription |
| Company | Alcon Pharms |
| 4 of 8 | |
|---|---|
| Drug Name | Patanol |
| PubMed Health | Olopatadine |
| Drug Classes | Nasal Agent, Ophthalmologic Agent |
| Drug Label | PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H1-receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to... |
| Active Ingredient | Olopatadine hydrochloride |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.1% base |
| Market Status | Prescription |
| Company | Alcon |
| 5 of 8 | |
|---|---|
| Drug Name | Olopatadine hydrochloride |
| Drug Label | Olopatadine Hydrochloride Nasal Solution (Nasal Spray), 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of Olopatadine Hydrochloride Nasal Solution (Nasal Spray), is a wh... |
| Active Ingredient | Olopatadine hydrochloride |
| Dosage Form | Solution/drops; Spray, metered; Solution |
| Route | Ophthalmic; Nasal; ophthalmic |
| Strength | 0.665mg/spray; 0.2% base; 0.1%; eq 0.1% base; 0.2% |
| Market Status | Tentative Approval; Prescription |
| Company | Wockhardt; Apotex; Sandoz; Watson Labs; Barr |
| 6 of 8 | |
|---|---|
| Drug Name | Pataday |
| Drug Label | PATADAY (olopatadine hydrochloride ophthalmic solution) 0.2% is a sterile ophthalmic solution containing olopatadine for topical administration to the eyes.Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular we... |
| Active Ingredient | Olopatadine hydrochloride |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.2% base |
| Market Status | Prescription |
| Company | Alcon Pharms |
| 7 of 8 | |
|---|---|
| Drug Name | Patanase |
| PubMed Health | Olopatadine (Into the nose) |
| Drug Classes | Nasal Agent |
| Drug Label | PATANASE (olopatadine hydrochloride) Nasal Spray, 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of PATANASE Nasal Spray, is a white, water-soluble crystalline powder. T... |
| Active Ingredient | Olopatadine hydrochloride |
| Dosage Form | Spray, metered |
| Route | Nasal |
| Strength | 0.665mg/spray |
| Market Status | Prescription |
| Company | Alcon Pharms |
| 8 of 8 | |
|---|---|
| Drug Name | Patanol |
| PubMed Health | Olopatadine |
| Drug Classes | Nasal Agent, Ophthalmologic Agent |
| Drug Label | PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H1-receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to... |
| Active Ingredient | Olopatadine hydrochloride |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.1% base |
| Market Status | Prescription |
| Company | Alcon |
Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.
Anti-Inflammatory Agents, Non-Steroidal
Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)
Histamine H1 Antagonists, Non-Sedating
A class of non-sedating drugs that bind to but do not activate histamine receptors (DRUG INVERSE AGONISM), thereby blocking the actions of histamine or histamine agonists. These antihistamines represent a heterogenous group of compounds with differing chemical structures, adverse effects, distribution, and metabolism. Compared to the early (first generation) antihistamines, these non-sedating antihistamines have greater receptor specificity, lower penetration of BLOOD-BRAIN BARRIER, and are less likely to cause drowsiness or psychomotor impairment. (See all compounds classified as Histamine H1 Antagonists, Non-Sedating.)
Anti-Allergic Agents
Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)
S01GX09
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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
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Rev. Date : 2013-02-07
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Submission : 2010-06-18
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DMF Number : 19526
Submission : 2006-06-14
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Submission : 2009-10-30
Status : Inactive
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DMF Number : 24106
Submission : 2010-08-27
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DMF Number : 24624
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DMF Number : 19417
Submission : 2006-05-09
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Olopatadine Hydrochloride IH/USP/IP
Date of Issue : 08-08-2025
Valid Till : 07-07-2028
Written Confirmation Number : WC-0055
Address of the Firm : Plot No. 19 & 20/2, MIDC, Dhatav, Taluka: Roha, District-Raigad, Maharashtra, In...
Date of Issue : 05-08-2025
Valid Till : 15-07-2028
Written Confirmation Number : WC-0152
Address of the Firm : Kilo Lab, R-92-93,15 Floor, T.T.C. M.I.D.C., Thane Belapur Road, Navi Mumbai., R...
Olopatadine Hydrochloride IP/JP/USP
Date of Issue : 2022-08-04
Valid Till : 2025-07-22
Written Confirmation Number : WC-0341
Address of the Firm : Plot No. J-46/57, MIDC Taloja Panvel, Raigad-410208, Maharashtra, India
Olopatadine Hydrochloride IH/USP
Date of Issue : 07-07-2025
Valid Till : 14-07-2028
Written Confirmation Number : WC-0021
Address of the Firm : Sy. Nos, 317,320,321,322,323,604 & 605, Pincode-502329, Rudraram (Village), Pata...
Date of Issue : 2022-07-27
Valid Till : 2025-07-26
Written Confirmation Number : WC-0531
Address of the Firm : Plot No. D-90/3 TTC IND Area, MIDC Turbhe, Navi Mumbai- 400705,Taluka: Pawvane, ...
Olopatadine Hydrochloride IH/USP
Date of Issue : 2022-06-08
Valid Till : 2025-07-25
Written Confirmation Number : WC-0159nA2
Address of the Firm : A-7/A-8, M.I.D.C Industrial Area, Ahmednagar-414111, Maharashtra, India
Olopatadine Hydrochloride USP/IH
Date of Issue : 14-07-2025
Valid Till : 06-02-2028
Written Confirmation Number : WC-0012
Address of the Firm : B-1/8,MIDC, Lote Parshuram, Tal., Dist. Ratnagiri, Khed - 415722, Taluka: Khed, ...
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Bhavna Laboratories is an API & Intermediate manufacturer focusing on the muscle relaxant & ophthalmic segments.
About the Company : Bhavna Laboratories Pvt. Ltd., founded in 1986, is an Indian company that specializes in manufacturing APIs and intermediates. Besides being approved by the FDA of India, Bhavna ha...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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About the Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with over 26 years of expertise in human and veterinary pharmaceuticals. Operating in 40+ countries, we own two st...
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About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...
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Drugs in Development
Details:
Dr. Reddy’s has launched of over-the-counter Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% and 0.1%, the storebrand equivalents of Pataday® Once Daily Relief and Pataday® Twice Daily Relief, in the U.S. market, as approved by the USFDA.
Lead Product(s): Olopatadine Hydrochloride,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Pataday-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 17, 2020
Lead Product(s) : Olopatadine Hydrochloride,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Dr. Reddy’s has launched of over-the-counter Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% and 0.1%, the storebrand equivalents of Pataday® Once Daily Relief and Pataday® Twice Daily Relief, in the U.S. market, as approved by the USFDA.
Product Name : Pataday-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 17, 2020
Details:
Olopatadine HCl is a mast cell stabilizer and a histamine H1 antagonist. It is indicated for the treatment of ocular itching associated with allergic conjunctivitis.
Lead Product(s): Olopatadine Hydrochloride,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Pataday-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 16, 2025
Lead Product(s) : Olopatadine Hydrochloride,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Glenmark USA Launches OTC Olopatadine Hydrochloride Ophthalmic Solution 0.2%
Details : Olopatadine HCl is a mast cell stabilizer and a histamine H1 antagonist. It is indicated for the treatment of ocular itching associated with allergic conjunctivitis.
Product Name : Pataday-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 16, 2025
Details:
Pataday-Generic (olopatadine hydrochloride) solution is a mast cell stabilizer indicated for the treatment of ocular itching associated with allergic conjunctivitis
Lead Product(s): Olopatadine Hydrochloride,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Pataday-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 20, 2025
Lead Product(s) : Olopatadine Hydrochloride,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Glenmark Secures ANDA for Olopatadine Hydrochloride Ophthalmic Solution
Details : Pataday-Generic (olopatadine hydrochloride) solution is a mast cell stabilizer indicated for the treatment of ocular itching associated with allergic conjunctivitis
Product Name : Pataday-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 20, 2025
Details:
Olopatadine HCl solution is a mast cell stabilizer, works by H1R antagonist, indicated for the treatment of ocular itching associated with allergic conjunctivitis.
Lead Product(s): Olopatadine Hydrochloride,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Pataday-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 04, 2024
Lead Product(s) : Olopatadine Hydrochloride,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Alembic Pharma Gets Tentative USFDA Nod for Olopatadine Drug
Details : Olopatadine HCl solution is a mast cell stabilizer, works by H1R antagonist, indicated for the treatment of ocular itching associated with allergic conjunctivitis.
Product Name : Pataday-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 04, 2024
Details:
Pataday-Generic (olopatadine hydrochloride) is a solution that is a mast cell stabilizer indicated for the treatment of ocular itching associated with allergic conjunctivitis.
Lead Product(s): Olopatadine Hydrochloride,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Pataday-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 19, 2024
Lead Product(s) : Olopatadine Hydrochloride,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Glenmark Launches OTC Olopatadine Hydrochloride Eye Drops in USA
Details : Pataday-Generic (olopatadine hydrochloride) is a solution that is a mast cell stabilizer indicated for the treatment of ocular itching associated with allergic conjunctivitis.
Product Name : Pataday-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 19, 2024
Details:
Undisclosed
Lead Product(s): Azelastine Hydrochloride,Mometasone Furoate,Olopatadine Hydrochloride
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 13, 2023
Lead Product(s) : Azelastine Hydrochloride,Mometasone Furoate,Olopatadine Hydrochloride
Therapeutic Area : Immunology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Azelastine Allergen Chamber - Onset of Action Study
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 13, 2023
Details:
RYALTRIS® (olopatadine hydrochloride and mometasone furoate nasal spray) treats moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults, adolescents, and children aged 6 years and older.
Lead Product(s): Olopatadine Hydrochloride,Mometasone Furoate
Therapeutic Area: Immunology Brand Name: Ryaltris
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Glenmark Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 23, 2022
Lead Product(s) : Olopatadine Hydrochloride,Mometasone Furoate
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Glenmark Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Bausch Health and Glenmark Announce the Approval of RYALTRIS® in Canada
Details : RYALTRIS® (olopatadine hydrochloride and mometasone furoate nasal spray) treats moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults, adolescents, and children aged 6 years and older.
Product Name : Ryaltris
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 23, 2022
Details:
The efficacy and safety of RYALTRIS (olopatadine hydrochloride) was established in a robust clinical studies program in over 4,000 patients with SAR. Twice-daily RYALTRIS™ provided statistically significant improvement in both nasal and ocular symptoms vs placebo.
Lead Product(s): Olopatadine Hydrochloride,Mometasone Furoate
Therapeutic Area: Immunology Brand Name: Ryaltris
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 30, 2022
Lead Product(s) : Olopatadine Hydrochloride,Mometasone Furoate
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Hikma Launches Ryaltris™ Seasonal Allergic Rhinitis Nasal Spray in The US
Details : The efficacy and safety of RYALTRIS (olopatadine hydrochloride) was established in a robust clinical studies program in over 4,000 patients with SAR. Twice-daily RYALTRIS™ provided statistically significant improvement in both nasal and ocular symptoms...
Product Name : Ryaltris
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 30, 2022
Details:
Undisclosed
Lead Product(s): Olopatadine Hydrochloride,Sodium Chloride,Fluticasone Propionate,Hypromellosum
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 06, 2022
Lead Product(s) : Olopatadine Hydrochloride,Sodium Chloride,Fluticasone Propionate,Hypromellosum
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Alle...
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 06, 2022
Details:
Undisclosed
Lead Product(s): Olopatadine Hydrochloride,Loratadine,Hypromellosum
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 04, 2022
Lead Product(s) : Olopatadine Hydrochloride,Loratadine,Hypromellosum
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Claritin® Tab...
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 04, 2022
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info :
Registration Country : India
Olopatadine Hydrochloride; Benzalkonium Chloride
Brand Name : ALLERNIL-HS
Dosage Form : Ophthalmic Solution
Dosage Strength : 0.2MG; 0.1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OLOPATADINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.1% BASE
Packaging :
Approval Date : 2019-09-26
Application Number : 209282
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OLOPATADINE HYDROCHLORIDE
Dosage Form : SPRAY, METERED;NASAL
Dosage Strength : 0.665MG/SPRAY
Packaging :
Approval Date : 2020-08-19
Application Number : 213757
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : South Korea
Brand Name : Pata Once Drops
Dosage Form : Eye Drop
Dosage Strength : 222MG/ML
Packaging : Multi-Dose (6ml)
Approval Date :
Application Number :
Regulatory Info :
Registration Country : South Korea
Regulatory Info :
Registration Country : Canada
OLOPATADINE (OLOPATADINE HYDROCHLORIDE)
Brand Name : MINT-OLOPATADINE
Dosage Form : SOLUTION
Dosage Strength : 0.1%/W/V
Packaging : 5ML
Approval Date :
Application Number : 2422727
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : USA
Brand Name : OLOPATADINE HYDROCHLORIDE
Dosage Form : SOLUTION; OPHTHALMIC
Dosage Strength : 0.1%
Packaging :
Approval Date :
Application Number : 90972
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Canada
OLOPATADINE (OLOPATADINE HYDROCHLORIDE)
Brand Name : OLOPATADINE 0.2%
Dosage Form : SOLUTION
Dosage Strength : 0.2%/W/V
Packaging :
Approval Date :
Application Number : 2541653
Regulatory Info :
Registration Country : Canada
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OLOPATADINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.1% BASE
Packaging :
Approval Date : 2017-01-10
Application Number : 204532
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OLOPATADINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.2% BASE
Packaging :
Approval Date : 2017-12-05
Application Number : 204723
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Generic
Registration Country : Turkey
Brand Name :
Dosage Form : EYE DROPS
Dosage Strength : 0.1%
Packaging : 5 Ml/Bottle
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD :
TE Code :
Brand Name : OLOPATADINE HYDROCHLORIDE
Dosage Form : SOLUTION;OPHTHALMIC
Dosage Strength : 0.2%
Approval Date :
Application Number : 202526
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code :
Brand Name : OLOPATADINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.1% BASE
Approval Date : 2018-12-07
Application Number : 209919
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code : AB
Brand Name : OLOPATADINE HYDROCHLORIDE
Dosage Form : SPRAY, METERED;NASAL
Dosage Strength : 0.665MG/SPRAY
Approval Date : 2020-01-28
Application Number : 210901
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : OLOPATADINE HYDROCHLORIDE
Dosage Form : SPRAY, METERED;NASAL
Dosage Strength : 0.665MG/SPRAY
Approval Date : 2014-10-08
Application Number : 91572
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Brand Name : OLOPATADINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.1% BASE
Approval Date : 2015-12-18
Application Number : 204812
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : OLOPATADINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.2% BASE
Approval Date : 2019-04-04
Application Number : 209995
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : OLOPATADINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.1% BASE
Approval Date : 2017-07-26
Application Number : 206046
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : OLOPATADINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.2% BASE
Approval Date : 2017-12-05
Application Number : 206087
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : OLOPATADINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.1% BASE
Approval Date : 2017-06-28
Application Number : 200810
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : Yes
TE Code :
MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE
Brand Name : RYALTRIS
Dosage Form : SPRAY, METERED;NASAL
Dosage Strength : 0.025MG/SPRAY;0.665MG/SPRAY
Approval Date : 2022-01-13
Application Number : 211746
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.7% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.7% BASE
USFDA APPLICATION NUMBER - 206276
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.1% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.1% BASE
USFDA APPLICATION NUMBER - 20688
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% BASE
USFDA APPLICATION NUMBER - 21545
DOSAGE - SPRAY, METERED;NASAL - 0.665MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21861
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ABOUT THIS PAGE
99
PharmaCompass offers a list of Olopatadine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Olopatadine Hydrochloride manufacturer or Olopatadine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Olopatadine Hydrochloride manufacturer or Olopatadine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Olopatadine Hydrochloride API Price utilized in the formulation of products. Olopatadine Hydrochloride API Price is not always fixed or binding as the Olopatadine Hydrochloride Price is obtained through a variety of data sources. The Olopatadine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock, including repackagers and relabelers. The FDA regulates Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock supplier is an individual or a company that provides Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock active pharmaceutical ingredient (API) or Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock finished formulations upon request. The Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock suppliers may include Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock API manufacturers, exporters, distributors and traders.
click here to find a list of Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock DMF (Drug Master File) is a document detailing the whole manufacturing process of Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock active pharmaceutical ingredient (API) in detail. Different forms of Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock DMFs exist exist since differing nations have different regulations, such as Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock DMF submitted to regulatory agencies in the US is known as a USDMF. Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock USDMF includes data on Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock Drug Master File in Japan (Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock JDMF) empowers Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock JDMF during the approval evaluation for pharmaceutical products. At the time of Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock Drug Master File in Korea (Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock. The MFDS reviews the Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock KDMF as part of the drug registration process and uses the information provided in the Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock KDMF to evaluate the safety and efficacy of the drug.
After submitting a Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock suppliers with KDMF on PharmaCompass.
A Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock written confirmation (Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock WC) is an official document issued by a regulatory agency to a Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock manufacturer, verifying that the manufacturing facility of a Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock APIs or Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock finished pharmaceutical products to another nation, regulatory agencies frequently require a Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock WC (written confirmation) as part of the regulatory process.
click here to find a list of Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock suppliers with NDC on PharmaCompass.
Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock GMP manufacturer or Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock GMP API supplier for your needs.
A Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock CoA (Certificate of Analysis) is a formal document that attests to Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock's compliance with Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock specifications and serves as a tool for batch-level quality control.
Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock CoA mostly includes findings from lab analyses of a specific batch. For each Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock may be tested according to a variety of international standards, such as European Pharmacopoeia (Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock EP), Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Olopatadine hydrochloride, Opatanol, Pataday, Patanase, Allelock USP).
