FDA.reportPublic FDA data

Application 207008

Type
ANDA
Sponsor
SUN PHARM

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
16714-078CinacalcetCinacalcetNorthStar RxLLCANDACurrent
16714-078CinacalcetCinacalcetNorthStar RxLLCANDACurrent
16714-078CinacalcetCinacalcetNorthStar RxLLCANDACurrent
16714-079CinacalcetCinacalcetNorthStar RxLLCANDACurrent
16714-079CinacalcetCinacalcetNorthStar RxLLCANDACurrent
16714-079CinacalcetCinacalcetNorthStar RxLLCANDACurrent
16714-080CinacalcetCinacalcetNorthStar RxLLCANDACurrent
16714-080CinacalcetCinacalcetNorthStar RxLLCANDACurrent
16714-080CinacalcetCinacalcetNorthStar RxLLCANDACurrent
47335-379CinacalcetCinacalcetSun Pharmaceutical Industries, Inc.ANDACurrent
47335-379CinacalcetCinacalcetSun Pharmaceutical Industries, Inc.ANDACurrent
47335-379CinacalcetCinacalcetSun Pharmaceutical Industries, Inc.ANDACurrent
47335-379CinacalcetCinacalcetSun Pharmaceutical Industries, Inc.ANDACurrent
47335-379CinacalcetCinacalcetSun Pharmaceutical Industries, Inc.ANDACurrent
47335-380CinacalcetCinacalcetSun Pharmaceutical Industries, Inc.ANDACurrent
47335-380CinacalcetCinacalcetSun Pharmaceutical Industries, Inc.ANDACurrent
47335-380CinacalcetCinacalcetSun Pharmaceutical Industries, Inc.ANDACurrent
47335-380CinacalcetCinacalcetSun Pharmaceutical Industries, Inc.ANDACurrent
47335-380CinacalcetCinacalcetSun Pharmaceutical Industries, Inc.ANDACurrent
47335-600CinacalcetCinacalcetSun Pharmaceutical Industries, Inc.ANDACurrent
47335-600CinacalcetCinacalcetSun Pharmaceutical Industries, Inc.ANDACurrent
47335-600CinacalcetCinacalcetSun Pharmaceutical Industries, Inc.ANDACurrent
47335-600CinacalcetCinacalcetSun Pharmaceutical Industries, Inc.ANDACurrent
47335-600CinacalcetCinacalcetSun Pharmaceutical Industries, Inc.ANDACurrent