Overview
No overview information available.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Greenstone LLC | 59762-2012 | SUBLINGUAL | 5 mg in 1 1 | 10/18/2023 | |
Greenstone LLC | 59762-2888 | SUBLINGUAL | 10 mg in 1 1 | 10/18/2023 | |
Allergan, Inc. | 0456-2405 | SUBLINGUAL | 5 mg in 1 1 | 7/31/2023 | |
Greenstone LLC | 59762-1091 | SUBLINGUAL | 2.5 mg in 1 1 | 10/18/2023 | |
Breckenridge Pharmaceutical, Inc. | 51991-360 | SUBLINGUAL | 10 mg in 1 1 | 1/31/2024 | |
MSN LABORATORIES PRIVATE LIMITED | 69539-060 | SUBLINGUAL | 10 mg in 1 1 | 8/26/2021 | |
MSN LABORATORIES PRIVATE LIMITED | 69539-058 | SUBLINGUAL | 5 mg in 1 1 | 8/26/2021 | |
Allergan, Inc. | 0456-2402 | SUBLINGUAL | 2.5 mg in 1 1 | 7/31/2023 | |
MSN LABORATORIES PRIVATE LIMITED | 69539-057 | SUBLINGUAL | 5 mg in 1 1 | 8/26/2021 | |
STAT RX USA LLC | 16590-936 | SUBLINGUAL | 10 mg in 1 1 | 2/16/2011 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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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 |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
SAPHRIS asenapine (as maleate) 10mg sublingual wafer blister pack | 166561 | Medicine | A | 3/11/2011 | |
SAPHRIS asenapine (as maleate) 5mg sublingual wafer blister pack | 166562 | Medicine | A | 3/11/2011 |
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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