FDA.reportPublic FDA data

Application 022128

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SELZENTRYMARAVIROCTABLET;ORAL150MGYesNo
002SELZENTRYMARAVIROCTABLET;ORAL300MGYesYes
003SELZENTRYMARAVIROCTABLET;ORAL25MGYesNo
004SELZENTRYMARAVIROCTABLET;ORAL75MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49702-223SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-223SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-223SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-223SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-223SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-223SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-223SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-223SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-224SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-224SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-224SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-224SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-224SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-224SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-224SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-224SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-233SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-233SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-233SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-233SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-233SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-233SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-233SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-233SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-235SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-235SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-235SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-235SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-235SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-235SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-235SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
49702-235SELZENTRYmaravirocViiV Healthcare CompanyNDACurrent
50090-1486SELZENTRYmaravirocA-S Medication SolutionsNDACurrent
50090-6238SELZENTRYmaravirocA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65139SUPPL2020-11-03
65138SUPPL2020-11-03
65128SUPPL2020-11-03
54932SUPPL2018-07-20
54916SUPPL2018-07-19
54915SUPPL2018-07-19
50201SUPPL2017-10-26
45848SUPPL2016-11-08
16999SUPPL2015-05-11
29301SUPPL2015-04-22
38291SUPPL2014-04-01
6946SUPPL2014-03-28
38290SUPPL2013-02-20
29300SUPPL2013-02-19
16998SUPPL2013-02-06
29299SUPPL2013-02-04
38289SUPPL2012-08-22
6945SUPPL2012-08-15
38288SUPPL2011-10-25
6944SUPPL2011-10-25
16997SUPPL2010-06-03
6943SUPPL2010-06-03
6942SUPPL2009-11-27
16996SUPPL2009-11-23
6941SUPPL2008-11-28
42425ORIG2007-10-05
16995ORIG2007-08-07
6940ORIG2007-08-07