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Last Updated: June 6, 2020

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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 patent protection?

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.

There are one hundred and four drug master file entries for rose bengal sodium i-131.

Summary for rose bengal sodium i-131
Medical Subject Heading (MeSH) Categories 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   Start Trial   Start Trial   Start Trial
Bracco ROBENGATOPE rose bengal sodium i-131 INJECTABLE;INJECTION 016224-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Bracco ROBENGATOPE rose bengal sodium i-131 INJECTABLE;INJECTION 016224-003 Approved Prior to Jan 1, 1982 DISCN No 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

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
Colorcon
Express Scripts
Mallinckrodt
Boehringer Ingelheim

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