FDA.reportPublic FDA data

Application 020705

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RESCRIPTORDELAVIRDINE MESYLATETABLET;ORAL100MGYesNo
002RESCRIPTORDELAVIRDINE MESYLATETABLET;ORAL200MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49702-209RESCRIPTORdelavirdine mesylateViiV Healthcare CompanyNDACurrent
49702-225RESCRIPTORdelavirdine mesylateViiV Healthcare CompanyNDACurrent
49702-225RESCRIPTORdelavirdine mesylateViiV Healthcare CompanyNDACurrent
49702-225RESCRIPTORdelavirdine mesylateViiV Healthcare CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
13253SUPPL2012-08-15
3142SUPPL2012-08-15
41593SUPPL2007-07-09
20862SUPPL2007-07-09
20861SUPPL2007-07-09
20860SUPPL2007-07-09
3141SUPPL2006-04-13
41592SUPPL2004-03-24
13252SUPPL2003-04-22
3140SUPPL2002-03-14
25581SUPPL1999-07-14
13251SUPPL1999-07-14