FDA.reportPublic FDA data

Application 022116

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEXIVAFOSAMPRENAVIR CALCIUMSUSPENSION;ORALEQ 50MG BASE/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49702-208LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
49702-208LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
49702-208LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
49702-208LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
49702-208LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
49702-208LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
49702-208LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
49702-208LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
49702-208LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58180SUPPL2019-04-02
58151SUPPL2019-03-29
50604SUPPL2017-12-05
50603SUPPL2017-12-05
45333SUPPL2016-09-20
45320SUPPL2016-09-16
29280SUPPL2016-03-24
16976SUPPL2016-03-23
38276SUPPL2015-07-22
6926SUPPL2015-07-20
16975SUPPL2015-04-02
29279SUPPL2015-04-01
38275SUPPL2013-02-14
29278SUPPL2013-02-14
29277SUPPL2012-05-02
38273SUPPL2012-05-01
6925SUPPL2012-02-27
38274SUPPL2012-02-22
29276SUPPL2011-05-16
16974SUPPL2011-05-16
38272SUPPL2010-05-03
6924SUPPL2010-04-29
42421ORIG2009-11-10
6923SUPPL2009-10-26
16973SUPPL2009-09-18
6922SUPPL2009-04-20
29275SUPPL2008-05-05
29274SUPPL2008-03-07
16972SUPPL2008-03-07
6921ORIG2007-07-05
16971ORIG2007-06-18