FDA.report

Application 022318

Type
NDA
Sponsor
GENZYME

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001RENVELASEVELAMER CARBONATEFOR SUSPENSION;ORAL800MG/PACKETYesNo
002RENVELASEVELAMER CARBONATEFOR SUSPENSION;ORAL2.4GM/PACKETYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0955-1052Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1052Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1052Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1052Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1052Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1052Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1054Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1054Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1054Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1054Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1054Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1054Sevelamer CarbonateSevelamer CarbonateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
58468-0131RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0131RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0131RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0131RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0131RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0131RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0131RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0131RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0132RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0132RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0132RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0132RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0132RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0132RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0132RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent
58468-0132RenvelaSEVELAMER CARBONATEGenzyme CorporationNDACurrent

Documents

DocumentSubmission typeDate
62806SUPPL2020-05-04
62786SUPPL2020-05-01
45997SUPPL2016-12-01
45962SUPPL2016-11-28
17236SUPPL2016-03-14
29588SUPPL2016-03-11
38568SUPPL2014-12-17
7228SUPPL2014-11-28
29587SUPPL2011-06-24
38567SUPPL2011-06-16
24281ORIG2011-02-03
21992ORIG2011-02-03
38566ORIG2009-10-01
7227ORIG2009-08-17