FDA.reportPublic FDA data

Application 210464

Type
ANDA
Sponsor
DR REDDYS LABS LTD

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
43598-478Sevelamer Carbonate for Oral SuspensionSevelamer Carbonate for Oral SuspensionDr. Reddys Laboratories IncANDACurrent
43598-478Sevelamer Carbonate for Oral SuspensionSevelamer Carbonate for Oral SuspensionDr. Reddys Laboratories IncANDACurrent
43598-479Sevelamer Carbonate for Oral SuspensionSevelamer Carbonate for Oral SuspensionDr. Reddys Laboratories IncANDACurrent
43598-479Sevelamer Carbonate for Oral SuspensionSevelamer Carbonate for Oral SuspensionDr. Reddys Laboratories IncANDACurrent