FDA.reportPublic FDA data

Application 208368

Type
ANDA
Sponsor
DR REDDYS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDETABLET;ORALEQ 30MG BASENoNo
002CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDETABLET;ORALEQ 60MG BASENoNo
003CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDETABLET;ORALEQ 90MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-367CinacalcetCinacalcetDr. Reddys Laboratories IncANDACurrent
43598-367CinacalcetCinacalcetDr. Reddys Laboratories IncANDACurrent
43598-368CinacalcetCinacalcetDr. Reddys Laboratories IncANDACurrent
43598-368CinacalcetCinacalcetDr. Reddys Laboratories IncANDACurrent
43598-369CinacalcetCinacalcetDr. Reddys Laboratories IncANDACurrent
43598-369CinacalcetCinacalcetDr. Reddys Laboratories IncANDACurrent
50268-153CinacalcetCinacalcetAvPAKANDACurrent