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Federal Trade Commission
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Fish and Richardson

Generated: December 16, 2017

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SULFANILAMIDE - Generic Drug Details

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What are the generic drug sources for sulfanilamide and what is the scope of sulfanilamide freedom to operate?

is the generic ingredient in two branded drugs marketed by Mylan Speciality Lp and G And W Labs Inc, 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. Two suppliers are listed for this compound.


Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
G And W Labs IncSULFANILAMIDEsulfanilamideCREAM;VAGINAL088718-001Sep 19, 1985DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Speciality LpAVCsulfanilamideSUPPOSITORY;VAGINAL006530-004Jan 27, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Speciality LpAVCsulfanilamideCREAM;VAGINAL006530-003Jan 27, 1987RXYesYes► Subscribe► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Farmers Insurance
Daiichi Sankyo
US Department of Justice

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