FDA.report

Application 021179

Type
NDA
Sponsor
GENZYME

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001RENAGELSEVELAMER HYDROCHLORIDETABLET;ORAL400MGYesNo
002RENAGELSEVELAMER HYDROCHLORIDETABLET;ORAL800MGYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0955-1048Sevelamer HydrochlorideSevelamer HydrochlorideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1048Sevelamer HydrochlorideSevelamer HydrochlorideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1048Sevelamer HydrochlorideSevelamer HydrochlorideWinthrop U.S, a business of sanofi-aventis U.S. LLCNDA AUTHORIZED GENERICCurrent
0955-1048Sevelamer HydrochlorideSevelamer HydrochlorideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1048Sevelamer HydrochlorideSevelamer HydrochlorideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1048Sevelamer HydrochlorideSevelamer HydrochlorideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
17856-0021RenagelRenagelAtlantic Biologicals CorpsNDACurrent
53808-0777RenagelRenagelDOH CENTRAL PHARMACYNDACurrent
58468-0020RenagelRenagelGenzyme CorporationNDACurrent
58468-0021Renagelsevelamer hydrochlorideGenzyme CorporationNDACurrent
58468-0021RenagelRenagelGenzyme CorporationNDACurrent
58468-0021Renagelsevelamer hydrochlorideGenzyme CorporationNDACurrent
58468-0021RenagelRenagelGenzyme CorporationNDACurrent
58468-0021RenagelRenagelGenzyme CorporationNDACurrent
67544-656RenagelRenagelAphena Pharma Solutions - Tennessee, LLCNDACurrent
68151-4295RENAGELRenagelCarilion Materials ManagementNDACurrent

Documents

DocumentSubmission typeDate
78035SUPPL 2024-04-02
78031SUPPL 2024-04-02
62804SUPPL2020-05-04
62788SUPPL2020-05-01
57785SUPPL2019-02-22
57766SUPPL2019-02-22
14586SUPPL2016-03-14
4572SUPPL2016-03-11
36297SUPPL2014-12-19
4571SUPPL2014-11-28
4570SUPPL2011-06-24
36296SUPPL2011-06-16
27004SUPPL2007-10-22
14584SUPPL2007-10-22
14585SUPPL2007-08-17
4569SUPPL2007-08-17
27003SUPPL2005-07-26
42003ORIG2004-03-11
27002SUPPL2004-03-03
27001ORIG2000-07-12
14583ORIG2000-07-12