OXYMETHOLONE - Generic Drug Details
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What are the generic sources for oxymetholone and what is the scope of freedom to operate?
Oxymetholone
is the generic ingredient in one branded drug marketed by Norvium Bioscience and is included in one NDA. Additional information is available in the individual branded drug profile pages.There is one drug master file entry for oxymetholone.
Summary for OXYMETHOLONE
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 37 |
| Clinical Trials: | 3 |
| Patent Applications: | 3,766 |
| What excipients (inactive ingredients) are in OXYMETHOLONE? | OXYMETHOLONE excipients list |
| DailyMed Link: | OXYMETHOLONE at DailyMed |
Recent Clinical Trials for OXYMETHOLONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Federal University of São Paulo | Phase 4 |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
| Boston Children’s Hospital | Phase 1/Phase 2 |
Medical Subject Heading (MeSH) Categories for OXYMETHOLONE
Anatomical Therapeutic Chemical (ATC) Classes for OXYMETHOLONE
US Patents and Regulatory Information for OXYMETHOLONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Norvium Bioscience | ANADROL-50 | oxymetholone | TABLET;ORAL | 016848-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
