Overview
A nonfluorinated corticosteroid anti-inflammatory agent used topically for dermatoses.
Indication
For the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatose.
Associated Conditions
- Dermatosis
- Ocular Inflammation
- Mild Atopic dermatitis
- Moderate Atopic dermatitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/11/29 | Phase 1 | Completed | MC2 Therapeutics | ||
2018/02/19 | Phase 1 | Recruiting | |||
2017/12/29 | Phase 3 | Completed | Procter and Gamble | ||
2016/04/08 | Phase 4 | Completed | Procter & Gamble Beauty | ||
2015/12/08 | Phase 4 | Withdrawn | EMS | ||
2014/11/10 | Phase 3 | UNKNOWN | |||
2012/03/02 | Phase 4 | Completed | |||
2011/11/08 | Phase 3 | Completed | |||
2009/01/26 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Alembic Pharmaceuticals Inc. | 62332-550 | TOPICAL | 0.5 mg in 1 mL | 12/13/2023 | |
| Alembic Pharmaceuticals Inc. | 62332-632 | TOPICAL | 0.5 mg in 1 g | 12/22/2023 | |
| Bryant Ranch Prepack | 72162-1272 | TOPICAL | 0.5 mg in 1 g | 1/31/2024 | |
| E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0309 | TOPICAL | 0.5 mg in 1 g | 2/24/2016 | |
| Teligent Pharma, Inc. | 52565-038 | TOPICAL | 0.5 mg in 1 g | 3/13/2019 | |
| NORTHSTAR RX LLC | 16714-729 | TOPICAL | 0.5 mg in 1 g | 7/19/2023 | |
| Actavis Pharma, Inc. | 0472-0804 | TOPICAL | 0.5 mg in 1 g | 1/28/2019 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-1281 | TOPICAL | 0.5 mg in 1 g | 1/31/2023 | |
| Bryant Ranch Prepack | 63629-2506 | TOPICAL | 0.5 mg in 1 g | 5/19/2021 | |
| Aleor Dermaceuticals Limited | 71589-005 | TOPICAL | 0.5 mg in 1 g | 11/30/2021 |
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 |
|---|---|---|---|---|---|
| DESOWEN CREAM 0.05% | SIN08252P | CREAM | 0.05% | 7/4/1995 | |
| DESOWEN LOTION 0.05% | SIN08572P | LOTION | 0.05% | 2/13/1996 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Desonide Cream | 国药准字H20253823 | 化学药品 | 乳膏剂 | 4/8/2025 | |
| Desonide Cream | 国药准字H20244058 | 化学药品 | 乳膏剂 | 6/18/2024 | |
| Desonide Cream | 国药准字H20243244 | 化学药品 | 乳膏剂 | 2/23/2024 | |
| Desonide Cream | 国药准字H20249111 | 化学药品 | 乳膏剂 | 10/22/2024 | |
| Desonide Cream | 国药准字H20060725 | 化学药品 | 乳膏剂 | 1/12/2021 | |
| Desonide Cream | 国药准字H20254157 | 化学药品 | 软膏剂 | 5/13/2025 | |
| Desonide Cream | 国药准字H20233813 | 化学药品 | 乳膏剂 | 6/27/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DESONIDE CREAM 0.05% W/W | N/A | bright future pharmaceuticals factory o/b bright future pharmaceutical laboratories limited | N/A | N/A | 1/8/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DESOWEN desonide 0.5 mg/g lotion bottle | 67182 | Medicine | A | 12/21/1998 | |
| DESOWEN Desonide 0.5mg/g ointment tube | 67174 | Medicine | A | 12/21/1998 | |
| DESOWEN Desonide 0.5mg/g cream tube | 67167 | Medicine | A | 12/21/1998 |
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