FDA.reportPublic FDA data

Application 203860

Type
ANDA
Sponsor
INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SEVELAMER CARBONATESEVELAMER CARBONATETABLET;ORAL800MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50436-0893Sevelamer carbonateSEVELAMER CARBONATEUnit Dose ServicesANDACurrent
67787-407Sevelamer carbonateSEVELAMER CARBONATEInvaGen Pharmaceuticals Inc.ANDACurrent
69097-893Sevelamer carbonateSEVELAMER CARBONATECipla USA Inc.ANDACurrent
69097-967Sevelamer carbonateSEVELAMER CARBONATECipla USA Inc.ANDACurrent
69097-967Sevelamer carbonateSEVELAMER CARBONATECipla USA Inc.ANDACurrent
69097-967Sevelamer carbonateSEVELAMER CARBONATECipla USA Inc.ANDACurrent
70518-0909Sevelamer carbonateSEVELAMER CARBONATEREMEDYREPACK INC.ANDACurrent
70518-0909Sevelamer carbonateSEVELAMER CARBONATEREMEDYREPACK INC.ANDACurrent
76282-407Sevelamer carbonateSEVELAMER CARBONATEExelan Pharmaceuticals Inc.ANDACurrent
76282-664Sevelamer carbonateSEVELAMER CARBONATEExelan Pharmaceuticals Inc.ANDACurrent
76282-664Sevelamer carbonateSEVELAMER CARBONATEExelan Pharmaceuticals Inc.ANDACurrent