Sulfanilamide - Generic Drug Details
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What are the generic drug sources for sulfanilamide and what is the scope of freedom to operate?
Sulfanilamide
is the generic ingredient in two branded drugs marketed by Mylan Speciality Lp and Cosette, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.There are six drug master file entries for sulfanilamide.
Summary for sulfanilamide
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 174 |
Clinical Trials: | 1 |
Patent Applications: | 6,070 |
Formulation / Manufacturing: | see details |
DailyMed Link: | sulfanilamide at DailyMed |
Recent Clinical Trials for sulfanilamide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Jilin Provincial Tumor Hospital | Phase 4 |
Peking Union Medical College Hospital | Phase 4 |
Peking University Third Hospital | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for sulfanilamide
US Patents and Regulatory Information for sulfanilamide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Speciality Lp | AVC | sulfanilamide | CREAM;VAGINAL | 006530-003 | Jan 27, 1987 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Cosette | SULFANILAMIDE | sulfanilamide | CREAM;VAGINAL | 088718-001 | Sep 19, 1985 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mylan Speciality Lp | AVC | sulfanilamide | SUPPOSITORY;VAGINAL | 006530-004 | Jan 27, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |