Overview
A topical glucocorticoid used in the treatment of eczema.
Indication
A topical anti-inflammatory product for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Associated Conditions
- Dermatosis
- Inflammation
- Pruritus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/07/16 | Phase 1 | Recruiting | |||
2023/11/18 | Not Applicable | Recruiting | |||
2014/11/26 | Not Applicable | Withdrawn | |||
2014/06/26 | N/A | Completed | |||
2013/03/01 | Early Phase 1 | Completed | |||
2011/11/10 | Phase 2 | Completed | |||
2011/08/24 | Phase 2 | Completed | |||
2010/01/14 | Phase 4 | Completed | |||
2009/01/09 | Phase 4 | Completed | |||
2008/04/28 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Teligent Pharma, Inc. | 52565-040 | TOPICAL | 0.5 mg in 1 g | 8/12/2016 | |
IPG PHARMACEUTICALS, INC. | 71085-005 | TOPICAL | 0.5 mg in 1 g | 2/15/2017 | |
A-S Medication Solutions | 50090-2419 | TOPICAL | 0.5 mg in 1 g | 12/6/2022 | |
Aidarex Pharmaceuticals LLC | 33261-560 | TOPICAL | 0.5 mg in 1 g | 8/23/2018 | |
Asclemed USA, Inc. | 76420-509 | TOPICAL | 1 mg in 1 g | 12/16/2023 | |
NuCare Pharmaceuticals,Inc. | 68071-1754 | TOPICAL | 0.5 mg in 1 g | 2/11/2021 | |
NuCare Pharmaceuticals, Inc. | 66267-973 | TOPICAL | 0.5 mg in 1 g | 1/11/2021 | |
NuCare Pharmaceuticals,Inc. | 68071-4921 | TOPICAL | 0.5 mg in 1 g | 2/18/2021 | |
Preferred Pharmaceuticals Inc. | 68788-8105 | TOPICAL | 0.5 mg in 1 g | 6/8/2023 | |
NuCare Pharmaceuticals,Inc. | 68071-2808 | TOPICAL | 0.5 mg in 1 g | 8/8/2022 |
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 |
---|---|---|---|---|---|
LIDEMOL 0.05% | syntex inc. | 00424943 | Cream
,
Emulsion - Topical | .05 % | 12/31/1979 |
LYDERM | taropharma, a division of taro pharmaceuticals inc. | 00716863 | Cream - Topical | 0.05 % / W/W | 12/31/1988 |
LYDONIDE EMOLLIENT CREAM 0.05% | technilab pharma inc. | 02187671 | Cream - Topical | .05 % | 7/30/1996 |
LIDEMOL | bausch health, canada inc. | 02163152 | Cream - Topical | 0.05 % / W/W | 12/31/1995 |
LIDEX OINTMENT MILD 0.01% | medicis canada ltd. | 00274445 | Ointment - Topical | 0.01 % | 12/31/1973 |
TOPSYN 0.05% | syntex inc. | 00281913 | Jelly - Topical | .5 MG / G | 12/31/1973 |
LIDEX CREAM MILD 0.01% | medicis canada ltd. | 00274453 | Cream - Topical | 0.01 % | 12/31/1972 |
LIDEX ONT 0.05% | syntex inc. | 00274437 | Ointment - Topical | .05 % | 12/31/1973 |
LIDEX | bausch health, canada inc. | 02161923 | Cream - Topical | 0.05 % / W/W | 12/31/1996 |
LYDERM | taropharma, a division of taro pharmaceuticals inc. | 02236996 | Ointment - Topical | 0.05 % | 10/15/1999 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
NOVOTER 0,5 MG/G CREMA | Teofarma S.R.L. | 54036 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized |
ABRASONE RECTAL, CREMA RECTAL | Anotaciones Farmaceuticas, S.L. | 56385 | CREMA RECTAL | Sin Receta | Commercialized |
NOVOTER GENTAMICINA 0,5 MG/G + 1 MG/G CREMA | Teofarma S.R.L. | 54003 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized |
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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