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Generated: January 21, 2018

DrugPatentWatch Database Preview

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. It is available from two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the sulfanilamide profile page.
Summary for 006530
Applicant:Mylan Speciality Lp
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 006530
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AVC sulfanilamide CREAM;VAGINAL 006530 NDA Meda Pharmaceuticals 0037-6631 0037-6631-04 1 TUBE, WITH APPLICATOR in 1 CARTON (0037-6631-04) > 113 g in 1 TUBE, WITH APPLICATOR
AVC sulfanilamide CREAM;VAGINAL 006530 NDA Jazz Pharmaceuticals Commercial Corp. 66663-103 66663-103-04 1 TUBE, WITH APPLICATOR in 1 CARTON (66663-103-04) > 113 g in 1 TUBE, WITH APPLICATOR

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CREAM;VAGINALStrength15%
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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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Argus Health

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