Application 213325

Type
ANDA
Sponsor
ACME LABS

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
71093-152CinacalcetCinacalcet HydrochlorideACI Healthcare USA, IncANDACurrent
71093-152CinacalcetCinacalcet HydrochlorideACI Healthcare USA, IncANDACurrent
71093-152CinacalcetCinacalcet HydrochlorideACI Healthcare USA, IncANDACurrent
71093-153CinacalcetCinacalcet HydrochlorideACI Healthcare USA, IncANDACurrent
71093-153CinacalcetCinacalcet HydrochlorideACI Healthcare USA, IncANDACurrent
71093-153CinacalcetCinacalcet HydrochlorideACI Healthcare USA, IncANDACurrent
71093-154CinacalcetCinacalcet HydrochlorideACI Healthcare USA, IncANDACurrent
71093-154CinacalcetCinacalcet HydrochlorideACI Healthcare USA, IncANDACurrent
71093-154CinacalcetCinacalcet HydrochlorideACI Healthcare USA, IncANDACurrent