Overview
Alcaftadine is a H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. This drug was approved in July 2010.
Indication
用于2岁以上人群过敏性结膜炎相关性眼部瘙痒的治疗。
Associated Conditions
- Allergic Conjunctivitis (AC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2015/09/22 | N/A | Completed | |||
2014/12/04 | Phase 4 | Completed | ORA, Inc. | ||
2014/06/11 | Phase 3 | Completed | |||
2014/03/10 | Phase 3 | Completed | |||
2013/03/11 | Phase 4 | UNKNOWN | Starx Research Center, LLC | ||
2012/12/21 | Phase 2 | Completed | |||
2012/11/26 | Phase 4 | Completed | |||
2011/11/11 | Phase 4 | Completed | |||
2009/04/28 | Phase 3 | Completed | Vistakon Pharmaceuticals |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Allergan, Inc. | 0023-4290 | OPHTHALMIC | 2.5 mg in 1 mL | 11/3/2023 | |
Rebel Distributors Corp | 42254-288 | OPHTHALMIC | 2.5 mg in 1 mL | 9/30/2010 | |
Physicians Total Care, Inc. | 54868-6294 | OPHTHALMIC | 2.5 mg in 1 mL | 8/22/2011 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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