FDA.reportPublic FDA data

Application 200959

Type
ANDA
Sponsor
TWI 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
24979-186Sevelamer CarbonateSevelamer CarbonateTWi Pharmaceuticals, Inc.ANDACurrent
24979-186Sevelamer CarbonateSevelamer CarbonateTWi Pharmaceuticals, Inc.ANDACurrent
71205-966Sevelamer CarbonateSevelamer CarbonateProficient Rx LPANDACurrent
71205-966Sevelamer CarbonateSevelamer CarbonateProficient Rx LPANDACurrent