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Last Updated: June 14, 2024

Details for New Drug Application (NDA): 006530

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NDA 006530 describes AVC, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. Additional details are available on the AVC profile page.

The generic ingredient in AVC is sulfanilamide. There are six drug master file entries for this compound. Additional details are available on the sulfanilamide profile page.
Summary for 006530
Applicant:Mylan Speciality Lp
Formulation / Manufacturing:see details

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;VAGINALStrength15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jan 27, 1987TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:SUPPOSITORY;VAGINALStrength1.05GM
Approval Date:Jan 27, 1987TE:RLD:No

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