FDA.reportPublic FDA data

Application 211316

Type
ANDA
Sponsor
IMPAX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SEVELAMER CARBONATESEVELAMER CARBONATEFOR SUSPENSION;ORAL800MG/PACKETNoNo
002SEVELAMER CARBONATESEVELAMER CARBONATEFOR SUSPENSION;ORAL2.4GM/PACKETNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1365sevelamer carbonatesevelamer carbonateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1365sevelamer carbonatesevelamer carbonateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1365sevelamer carbonatesevelamer carbonateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1366sevelamer carbonatesevelamer carbonateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1366sevelamer carbonatesevelamer carbonateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1366sevelamer carbonatesevelamer carbonateAmneal Pharmaceuticals of New York LLCANDACurrent