FDA.reportPublic FDA data

Application 090975

Type
ANDA
Sponsor
IMPAX LABS INC

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
0115-1309Sevelamer CarbonateSevelamer CarbonateImpax GenericsANDACurrent
0115-1309Sevelamer CarbonateSevelamer CarbonateImpax GenericsANDACurrent
42291-763Sevelamer CarbonateSevelamer CarbonateAvKARE, Inc.ANDACurrent
42291-763Sevelamer CarbonateSevelamer CarbonateAvKAREANDACurrent
70518-1102Sevelamer CarbonateSevelamer CarbonateREMEDYREPACK INC.ANDACurrent
70518-1102Sevelamer CarbonateSevelamer CarbonateREMEDYREPACK INC.ANDACurrent