Hydrocortisone; urea - Generic Drug Details
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What are the generic drug sources for hydrocortisone; urea and what is the scope of freedom to operate?
Hydrocortisone; urea
is the generic ingredient in two branded drugs marketed by Bioglan and Pharmacia And Upjohn, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.Summary for hydrocortisone; urea
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 8 |
| Clinical Trials: | 482 |
| DailyMed Link: | hydrocortisone; urea at DailyMed |
Recent Clinical Trials for hydrocortisone; urea
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Virginia | PHASE3 |
| National Institute of Allergy and Infectious Diseases (NIAID) | PHASE3 |
| Assistance Publique - Hôpitaux de Paris | PHASE3 |
Anatomical Therapeutic Chemical (ATC) Classes for hydrocortisone; urea
US Patents and Regulatory Information for hydrocortisone; urea
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharmacia And Upjohn | CALMURID HC | hydrocortisone; urea | CREAM;TOPICAL | 083947-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bioglan | ALPHADERM | hydrocortisone; urea | CREAM;TOPICAL | 086008-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
