Overview
No overview information available.
Background
No background information available.
Indication
For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Also used to treat endocrine (hormonal) disorders (adrenal insufficiency, Addisons disease). It is also used to treat many immune and allergic disorders, such as arthritis, lupus, severe psoriasis, severe asthma, ulcerative colitis, and Crohn's disease.
Associated Conditions
- Atopic Dermatitis
- Corticosteroid responsive, Inflammatory Dermatosis
- Corticosteroid responsive, pruritic Dermatosis
- Pruritic, corticosteroid responsive, Inflammatory Dermatosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/11/25 | Phase 1 | Completed | |||
2016/11/09 | Phase 4 | UNKNOWN | |||
2014/06/03 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bausch Health US, LLC | 16781-384 | TOPICAL | 1 mg in 1 g | 3/31/2021 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-4083 | TOPICAL | 1 mg in 1 g | 4/6/2021 | |
| Teligent Pharma, Inc. | 52565-087 | TOPICAL | 1 mg in 1 mL | 9/10/2019 | |
| Lupin Pharmaceuticals, Inc. | 68180-951 | TOPICAL | 1 mg in 1 mL | 12/13/2019 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-4061 | TOPICAL | 1 mg in 1 mL | 4/6/2021 | |
| Oceanside Pharmaceuticals | 68682-392 | TOPICAL | 1 mg in 1 mL | 12/11/2023 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-4074 | TOPICAL | 1 mg in 1 g | 4/6/2021 | |
| Oceanside Pharmaceuticals | 68682-384 | TOPICAL | 1 mg in 1 g | 3/31/2021 | |
| The J. Molner Company LLC | 83148-012 | TOPICAL | 1 mg in 1 mL | 11/30/2023 | |
| Pella Pharmaceuticals Co. ltd | 82160-127 | TOPICAL | 30 mg in 30 g | 12/26/2023 |
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 |
|---|---|---|---|---|---|
| Hydrocortisone Butyrate Cream | 国药准字H20074088 | 化学药品 | 乳膏剂 | 12/24/2021 | |
| Hydrocortisone Butyrate Cream | 国药准字H20058397 | 化学药品 | 乳膏剂 | 8/29/2020 | |
| Hydrocortisone Butyrate Cream | 国药准字H20163449 | 化学药品 | 乳膏剂 | 6/2/2021 | |
| Hydrocortisone Butyrate Cream | 国药准字H20083928 | 化学药品 | 乳膏剂 | 8/14/2023 | |
| Hydrocortisone Butyrate Cream | 国药准字H20063223 | 化学药品 | 乳膏剂 | 9/10/2020 | |
| Hydrocortisone Butyrate Cream | 国药准字H10940095 | 化学药品 | 乳膏剂 | 12/24/2019 | |
| Hydrocortisone Butyrate Cream | 国药准字H20074171 | 化学药品 | 乳膏剂 | 9/2/2022 | |
| Hydrocortisone Butyrate Cream | 国药准字H20083906 | 化学药品 | 乳膏剂 | 9/15/2022 | |
| Hydrocortisone Butyrate Cream | 国药准字H20074168 | 化学药品 | 乳膏剂 | 8/16/2022 | |
| Hydrocortisone Butyrate Cream | 国药准字H20093962 | 化学药品 | 乳膏剂 | 11/14/2023 |
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. | |||||