FDA.reportPublic FDA data

Application 205109

Type
NDA
Sponsor
VIFOR FRESENIUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VELPHOROSUCROFERRIC OXYHYDROXIDETABLET, CHEWABLE;ORAL500MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49230-645Velphorosucroferric oxyhydroxideFresenius Medical Care North AmericaNDACurrent
49230-645Velphorosucroferric oxyhydroxideFresenius Medical Care North AmericaNDACurrent
49230-645Velphorosucroferric oxyhydroxideFresenius Medical Care North AmericaNDACurrent
49230-645Velphorosucroferric oxyhydroxideFresenius Medical Care North AmericaNDACurrent
49230-645Velphorosucroferric oxyhydroxideFresenius Medical Care North AmericaNDACurrent
49230-645Velphorosucroferric oxyhydroxideFresenius Medical Care North AmericaNDACurrent
49230-645Velphorosucroferric oxyhydroxideFresenius Medical Care North AmericaNDACurrent
49230-645Velphorosucroferric oxyhydroxideFresenius Medical Care North AmericaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79495SUPPL 2024-08-29
79492SUPPL 2024-08-28
78987SUPPL 2024-07-08
78958SUPPL 2024-07-02
62015SUPPL2020-03-03
62008SUPPL2020-03-02
53867SUPPL2018-04-27
53821SUPPL2018-04-26
49262SUPPL2017-08-07
49254SUPPL2017-08-07
40446SUPPL2014-09-26
32632SUPPL2014-09-26
44914ORIG2014-08-07
22975ORIG2014-08-07
40445ORIG2014-03-24
10426ORIG2013-11-29