FDA.reportPublic FDA data

Application 207288

Type
ANDA
Sponsor
AMNEAL PHARMS CO

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
10135-660Sevelamer CarbonateSevelamer CarbonateMarlex Pharmaceuticals IncANDACurrent
17856-0058Sevelamer CarbonateSevelamer CarbonateAtlantic Biologicals CorpsANDACurrent
50268-720Sevelamer CarbonateSevelamer CarbonateAvPAKANDACurrent
50268-720Sevelamer CarbonateSevelamer CarbonateAvPAKANDACurrent
65162-058Sevelamer CarbonateSevelamer CarbonateAmneal Pharmaceuticals LLCANDACurrent
65162-058Sevelamer CarbonateSevelamer CarbonateAmneal Pharmaceuticals LLCANDACurrent
65162-058Sevelamer CarbonateSevelamer CarbonateAmneal Pharmaceuticals LLCANDACurrent
65162-058Sevelamer CarbonateSevelamer CarbonateAmneal Pharmaceuticals LLCANDACurrent
68094-034Sevelamer CarbonateSevelamer CarbonatePrecision Dose, Inc.ANDACurrent
68094-034Sevelamer CarbonateSevelamer CarbonatePrecision Dose, Inc.ANDACurrent
70518-1707Sevelamer CarbonateSevelamer CarbonateREMEDYREPACK INC.ANDACurrent
70518-1707Sevelamer CarbonateSevelamer CarbonateREMEDYREPACK INC.ANDACurrent