FDA.reportPublic FDA data

Application 203422

Type
ANDA
Sponsor
MYLAN

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
0378-6195Cinacalcet HydrochlorideCinacalcet HydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6195Cinacalcet HydrochlorideCinacalcet HydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6195CinacalcetCinacalcetMylan Pharmaceuticals Inc.ANDACurrent
0378-6195CinacalcetCinacalcetMylan Pharmaceuticals Inc.ANDACurrent
0378-6195CinacalcetCinacalcetMylan Pharmaceuticals Inc.ANDACurrent
0378-6196Cinacalcet HydrochlorideCinacalcet HydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6196Cinacalcet HydrochlorideCinacalcet HydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6196CinacalcetCinacalcetMylan Pharmaceuticals Inc.ANDACurrent
0378-6196CinacalcetCinacalcetMylan Pharmaceuticals Inc.ANDACurrent
0378-6196CinacalcetCinacalcetMylan Pharmaceuticals Inc.ANDACurrent
0378-6197Cinacalcet HydrochlorideCinacalcet HydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6197Cinacalcet HydrochlorideCinacalcet HydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6197CinacalcetCinacalcetMylan Pharmaceuticals Inc.ANDACurrent
0378-6197CinacalcetCinacalcetMylan Pharmaceuticals Inc.ANDACurrent
0378-6197CinacalcetCinacalcetMylan Pharmaceuticals Inc.ANDACurrent