ROSE BENGAL SODIUM I-131 - Generic Drug Details
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What are the generic sources for rose bengal sodium i-131 and what is the scope of freedom to operate?
Rose bengal sodium i-131
is the generic ingredient in two branded drugs marketed by Bracco and Sorin, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.Summary for ROSE BENGAL SODIUM I-131
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Clinical Trials: | 3 |
| DailyMed Link: | ROSE BENGAL SODIUM I-131 at DailyMed |
Recent Clinical Trials for ROSE BENGAL SODIUM I-131
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | N/A |
| Universidade Federal do Rio de Janeiro | Phase 4 |
| Santen Pharmaceutical Co., Ltd. | Phase 3 |
Medical Subject Heading (MeSH) Categories for ROSE BENGAL SODIUM I-131
Anatomical Therapeutic Chemical (ATC) Classes for ROSE BENGAL SODIUM I-131
US Patents and Regulatory Information for ROSE BENGAL SODIUM I-131
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sorin | SODIUM ROSE BENGAL I 131 | rose bengal sodium i-131 | INJECTABLE;INJECTION | 017318-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bracco | ROBENGATOPE | rose bengal sodium i-131 | INJECTABLE;INJECTION | 016224-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bracco | ROBENGATOPE | rose bengal sodium i-131 | INJECTABLE;INJECTION | 016224-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bracco | ROBENGATOPE | rose bengal sodium i-131 | INJECTABLE;INJECTION | 016224-001 | Approved Prior to Jan 1, 1982 | DISCN | No | 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 |
