FDA.reportPublic FDA data

Application 022127

Type
NDA
Sponsor
SANOFI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RENVELASEVELAMER CARBONATETABLET;ORAL800MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0955-1050Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1050Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1050Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1050Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1050Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1050Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
17856-0130RenvelaSEVELAMER CARBONATEAtlantic Biologicals CorpsNDACurrent
58468-0130RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0130RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0130RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0130RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0130RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0130RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0130RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0130RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
68151-5113RenvelaSEVELAMER CARBONATECarilion Materials ManagementNDACurrent
70518-2490Sevelamer CarbonateSevelamer CarbonateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2490Sevelamer CarbonateSevelamer CarbonateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2490Sevelamer CarbonateSevelamer CarbonateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74458SUPPL 2023-06-07
74457SUPPL 2023-06-07
62805SUPPL2020-05-04
62785SUPPL2020-05-01
45996SUPPL2016-12-01
45961SUPPL2016-11-28
16994SUPPL2016-03-14
29298SUPPL2016-03-11
16993SUPPL2014-12-17
6939SUPPL2014-11-28
29297SUPPL2011-06-24
16992SUPPL2011-06-16
24247ORIG2008-08-29
21943ORIG2008-08-29
29296ORIG2007-10-22
16991ORIG2007-10-22
51661SUPPL1900-01-01
51660SUPPL1900-01-01
51658SUPPL1900-01-01