FDA.reportPublic FDA data

Application 021548

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEXIVAFOSAMPRENAVIR CALCIUMTABLET;ORALEQ 700MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49702-207LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
49702-207LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
49702-207LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
49702-207LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
49702-207LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
49702-207LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
49702-207LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
49702-207LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
49702-207LEXIVAfosamprenavir calciumViiV Healthcare CompanyNDACurrent
53808-0281LEXIVAfosamprenavir calciumState of Florida DOH Central PharmacyNDACurrent
53808-1010LEXIVAfosamprenavir calciumState of Florida DOH Central PharmacyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58179SUPPL2019-04-02
58149SUPPL2019-03-29
50602SUPPL2017-12-05
50601SUPPL2017-12-05
45383SUPPL2016-09-27
45334SUPPL2016-09-20
28094SUPPL2016-03-24
15762SUPPL2016-03-23
15761SUPPL2015-07-22
5710SUPPL2015-07-20
37203SUPPL2015-04-02
5711SUPPL2015-04-01
28093SUPPL2013-02-14
15760SUPPL2013-02-14
28092SUPPL2012-05-02
15758SUPPL2012-05-01
5709SUPPL2012-02-27
15759SUPPL2012-02-22
52956SUPPL2012-01-10
52955SUPPL2012-01-10
51618SUPPL2012-01-10
51617SUPPL2012-01-10
51616SUPPL2012-01-10
51615SUPPL2012-01-10
51614SUPPL2012-01-10
51613SUPPL2012-01-10
28091SUPPL2011-05-16
15757SUPPL2011-05-16
37202SUPPL2010-05-03
5708SUPPL2010-04-29
28090SUPPL2009-10-26
15756SUPPL2009-09-18
5707SUPPL2009-04-20
28089SUPPL2008-05-05
28088SUPPL2008-03-07
15755SUPPL2008-03-07
15754SUPPL2008-02-25
5706SUPPL2008-02-22
5705SUPPL2008-01-09
5704SUPPL2008-01-09
15753SUPPL2007-12-27
15752SUPPL2007-12-14
5703SUPPL2007-10-22
15751SUPPL2007-10-15
15749SUPPL2007-02-21
28087SUPPL2007-02-12
5702SUPPL2006-11-22
15750SUPPL2006-11-16
15748SUPPL2006-08-09
5701SUPPL2006-08-09
37201SUPPL2006-05-16
28086SUPPL2006-05-16
5700SUPPL2006-03-23
15747SUPPL2006-03-14
5699SUPPL2005-11-18
15746SUPPL2005-11-17
28085SUPPL2005-06-14
15745SUPPL2005-06-14
15744SUPPL2004-12-03
5698SUPPL2004-12-02
21729ORIG2004-10-26
15743ORIG2003-10-27
5697ORIG2003-10-27