FDA.reportPublic FDA data

Application 210570

Type
ANDA
Sponsor
ALKEM LABS LTD

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
0904-7067CinacalcetCinacalcetMajor PharmaceuticalsANDACurrent
0904-7067CinacalcetCinacalcetMajor PharmaceuticalsANDACurrent
60687-525CinacalcetCinacalcetAmerican Health PackagingANDACurrent
60687-525CinacalcetCinacalcetAmerican Health PackagingANDACurrent
60687-525CinacalcetCinacalcetAmerican Health PackagingANDACurrent
63629-8763CinacalcetCinacalcetBryant Ranch PrepackANDACurrent
63629-8763CinacalcetCinacalcetBryant Ranch PrepackANDACurrent
63629-8763CinacalcetCinacalcetBryant Ranch PrepackANDACurrent
63629-8764CinacalcetCinacalcetBryant Ranch PrepackANDACurrent
63629-8764CinacalcetCinacalcetBryant Ranch PrepackANDACurrent
63629-8764CinacalcetCinacalcetBryant Ranch PrepackANDACurrent
63629-8765CinacalcetCinacalcetBryant Ranch PrepackANDACurrent
63629-8765CinacalcetCinacalcetBryant Ranch PrepackANDACurrent
63629-8765CinacalcetCinacalcetBryant Ranch PrepackANDACurrent
63629-9606CinacalcetCinacalcetBryant Ranch PrepackANDACurrent
63629-9607CinacalcetCinacalcetBryant Ranch PrepackANDACurrent
63629-9608CinacalcetCinacalcetBryant Ranch PrepackANDACurrent
67877-503CinacalcetCinacalcetAscend Laboratories, LLCANDACurrent
67877-503CinacalcetCinacalcetAscend Laboratories, LLCANDACurrent
67877-503CinacalcetCinacalcetAscend Laboratories, LLCANDACurrent
67877-503CinacalcetCinacalcetAscend Laboratories, LLCANDACurrent
67877-504CinacalcetCinacalcetAscend Laboratories, LLCANDACurrent
67877-504CinacalcetCinacalcetAscend Laboratories, LLCANDACurrent
67877-504CinacalcetCinacalcetAscend Laboratories, LLCANDACurrent
67877-504CinacalcetCinacalcetAscend Laboratories, LLCANDACurrent
67877-505CinacalcetCinacalcetAscend Laboratories, LLCANDACurrent
67877-505CinacalcetCinacalcetAscend Laboratories, LLCANDACurrent
67877-505CinacalcetCinacalcetAscend Laboratories, LLCANDACurrent
67877-505CinacalcetCinacalcetAscend Laboratories, LLCANDACurrent