FDA.reportPublic FDA data

Application 020977

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZIAGENABACAVIR SULFATETABLET;ORALEQ 300MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49702-221ZIAGENabacavir sulfateViiV Healthcare CompanyNDACurrent
49702-221ZIAGENabacavir sulfateViiV Healthcare CompanyNDACurrent
49702-221ZIAGENabacavir sulfateViiV Healthcare CompanyNDACurrent
49702-221ZIAGENabacavir sulfateViiV Healthcare CompanyNDACurrent
49702-221ZIAGENabacavir sulfateViiV Healthcare CompanyNDACurrent
49702-221ZIAGENabacavir sulfateViiV Healthcare CompanyNDACurrent
53808-0811ZIAGENabacavir sulfateState of Florida DOH Central PharmacyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65351SUPPL2020-11-27
65340SUPPL2020-11-25
65337SUPPL2020-11-25
61165SUPPL2019-12-05
54251SUPPL2018-05-18
54250SUPPL2018-05-18
54249SUPPL2018-05-18
54074SUPPL2018-05-10
54073SUPPL2018-05-10
47688SUPPL2017-03-24
47619SUPPL2017-03-21
35771SUPPL2015-10-07
3912SUPPL2015-10-02
35769SUPPL2015-04-01
3910SUPPL2015-03-25
3911SUPPL2015-02-24
35770SUPPL2015-02-20
35768SUPPL2013-09-17
26360SUPPL2013-09-13
35767SUPPL2012-05-22
3909SUPPL2012-05-22
3908SUPPL2012-03-19
35766SUPPL2012-03-16
26359SUPPL2011-11-22
14070SUPPL2011-11-22
26358SUPPL2011-05-17
26357SUPPL2010-08-10
26351SUPPL2009-08-25
3906SUPPL2009-08-25
14069SUPPL2009-01-02
26356SUPPL2008-12-29
26355SUPPL2008-07-23
14068SUPPL2008-07-22
41856SUPPL2007-09-26
21321SUPPL2007-09-26
35765SUPPL2007-05-09
26354SUPPL2007-05-09
26353SUPPL2006-08-21
14067SUPPL2006-08-14
14066SUPPL2004-08-05
3907SUPPL2004-08-05
35764SUPPL2004-07-28
26352SUPPL2004-07-28
35763SUPPL2004-05-03
3905SUPPL2004-04-20
41855SUPPL2004-04-14
44084ORIG2003-12-12
14065SUPPL2003-09-25
3904SUPPL2003-07-28
26349SUPPL2002-10-02
14063SUPPL2002-10-02
26350SUPPL2002-08-14
14064SUPPL2002-08-14
26348SUPPL2002-01-28
41854ORIG1998-12-17
35762ORIG1998-12-17
3903ORIG1998-12-17
51935SUPPL1900-01-01
51934SUPPL1900-01-01