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Last Updated: June 12, 2021

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Sulfisoxazole diolamine - Generic Drug Details

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What are the generic sources for sulfisoxazole diolamine and what is the scope of freedom to operate?

Sulfisoxazole diolamine is the generic ingredient in two branded drugs marketed by Roche and Sola Barnes Hind, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for sulfisoxazole diolamine.

Summary for sulfisoxazole diolamine

US Patents and Regulatory Information for sulfisoxazole diolamine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche GANTRISIN sulfisoxazole diolamine SOLUTION/DROPS;OPHTHALMIC 007757-002 Approved Prior to Jan 1, 1982 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Roche GANTRISIN sulfisoxazole diolamine OINTMENT;OPHTHALMIC 008414-002 Approved Prior to Jan 1, 1982 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Roche GANTRISIN sulfisoxazole diolamine INJECTABLE;INJECTION 006917-001 Approved Prior to Jan 1, 1982 DISCN No No   Get Started Free   Get Started Free   Get Started Free
>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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