FDA.reportPublic FDA data

Application 208915

Type
ANDA
Sponsor
CIPLA

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
69097-410CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-410CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-410CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-410CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-410CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-410CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-410CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-411CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-411CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-411CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-411CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-411CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-411CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-412CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-412CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-412CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-412CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-412CINACALCETCINACALCETCipla USA Inc.ANDACurrent
69097-412CINACALCETCINACALCETCipla USA Inc.ANDACurrent
76282-674CINACALCETCINACALCETEXELAN PHARMACEUTICALS INC.ANDACurrent
76282-675CINACALCETCINACALCETEXELAN PHARMACEUTICALS INC.ANDACurrent
76282-676CINACALCETCINACALCETEXELAN PHARMACEUTICALS INC.ANDACurrent