FDA.reportPublic FDA data

Application 021526

Type
NDA
Sponsor
GILEAD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANEXARANOLAZINETABLET, EXTENDED RELEASE;ORAL1GMYesYes
002RANEXARANOLAZINETABLET, EXTENDED RELEASE;ORAL500MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43353-880RanexaRANOLAZINEAphena Pharma Solutions - Tennessee, LLCNDACurrent
61958-1001RanexaranolazineGilead Sciences, Inc.NDACurrent
61958-1002RanexaranolazineGilead Sciences, Inc.NDACurrent
61958-1003RanexaRANOLAZINEGilead Sciences, Inc.NDACurrent
61958-1003RanexaRANOLAZINEGilead Sciences, Inc.NDACurrent
61958-1003RanexaRANOLAZINEGilead Sciences, Inc.NDACurrent
61958-1003RanexaRANOLAZINEGilead Sciences, Inc.NDACurrent
61958-1003RanexaRANOLAZINEGilead Sciences, Inc.NDACurrent
61958-1004RanexaRANOLAZINEGilead Sciences, Inc.NDACurrent
61958-1004RanexaRANOLAZINEGilead Sciences, Inc.NDACurrent
61958-1004RanexaRANOLAZINEGilead Sciences, Inc.NDACurrent
61958-1004RanexaRANOLAZINEGilead Sciences, Inc.NDACurrent
61958-1004RanexaRANOLAZINEGilead Sciences, Inc.NDACurrent
68151-5004RanexaRANOLAZINECarilion Materials ManagementNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60726SUPPL2019-10-30
60724SUPPL2019-10-30
59665SUPPL2019-08-13
59641SUPPL2019-08-08
28028SUPPL2016-01-07
15689SUPPL2016-01-07
37157SUPPL2015-12-17
28027SUPPL2015-12-16
21716SUPPL2015-01-16
21717SUPPL2014-08-05
37156SUPPL2013-12-23
28026SUPPL2013-12-20
5643SUPPL2013-11-15
15688SUPPL2013-11-14
5642SUPPL2012-07-30
37155SUPPL2012-07-26
5641SUPPL2011-12-28
37154SUPPL2011-12-23
5640SUPPL2011-07-13
15687SUPPL2011-07-11
37153SUPPL2010-09-29
28025SUPPL2010-09-28
5639SUPPL2009-03-27
15686SUPPL2009-03-26
37152SUPPL2008-11-07
5638SUPPL2008-11-06
28024SUPPL2008-01-09
15685SUPPL2007-12-27
21715ORIG2006-04-06
5637ORIG2006-02-08
37151ORIG2006-02-07