FDA.reportPublic FDA data

Application 204364

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDETABLET;ORAL30MGNoNo
002CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDETABLET;ORAL60MGNoNo
003CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDETABLET;ORAL90MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-155Cinacalcet HydrochlorideCinacalcetAmneal Pharmaceuticals LLCANDACurrent
65162-155Cinacalcet HydrochlorideCinacalcetAmneal Pharmaceuticals LLCANDACurrent
65162-157Cinacalcet HydrochlorideCinacalcetAmneal Pharmaceuticals LLCANDACurrent
65162-157Cinacalcet HydrochlorideCinacalcetAmneal Pharmaceuticals LLCANDACurrent
65162-213Cinacalcet HydrochlorideCinacalcetAmneal Pharmaceuticals LLCANDACurrent
65162-213Cinacalcet HydrochlorideCinacalcetAmneal Pharmaceuticals LLCANDACurrent