FDA.reportPublic FDA data

Application 208325

Type
NDA
Sponsor
KAI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PARSABIVETELCALCETIDESOLUTION;INTRAVENOUS2.5MG/0.5ML (2.5MG/0.5ML)YesYes
002PARSABIVETELCALCETIDESOLUTION;INTRAVENOUS5MG/ML (5MG/ML)YesYes
003PARSABIVETELCALCETIDESOLUTION;INTRAVENOUS10MG/2ML (5MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-740PARSABIVetelcalcetideAmgen IncNDACurrent
55513-740PARSABIVetelcalcetideAmgen IncNDACurrent
55513-740PARSABIVetelcalcetideAmgen IncNDACurrent
55513-740PARSABIVetelcalcetideAmgen IncNDACurrent
55513-740PARSABIVetelcalcetideAmgen IncNDACurrent
55513-741PARSABIVetelcalcetideAmgen IncNDACurrent
55513-741PARSABIVetelcalcetideAmgen IncNDACurrent
55513-741PARSABIVetelcalcetideAmgen IncNDACurrent
55513-741PARSABIVetelcalcetideAmgen IncNDACurrent
55513-741PARSABIVetelcalcetideAmgen IncNDACurrent
55513-742PARSABIVetelcalcetideAmgen IncNDACurrent
55513-742PARSABIVetelcalcetideAmgen IncNDACurrent
55513-742PARSABIVetelcalcetideAmgen IncNDACurrent
55513-742PARSABIVetelcalcetideAmgen IncNDACurrent
55513-742PARSABIVetelcalcetideAmgen IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66210SUPPL2021-02-16
57962SUPPL2019-03-12
57957SUPPL2019-03-12
55324SUPPL2018-08-27
55255SUPPL2018-08-21
47628ORIG2017-03-21
47138ORIG2017-02-08
47131ORIG2017-02-08