FDA.reportPublic FDA data

Application 208379

Type
NDA
Sponsor
MEDICURE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYPITAMAGPITAVASTATIN MAGNESIUMTABLET;ORALEQ 1MG BASEYesNo
002ZYPITAMAGPITAVASTATIN MAGNESIUMTABLET;ORALEQ 2MG BASEYesNo
003ZYPITAMAGPITAVASTATIN MAGNESIUMTABLET;ORALEQ 4MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25208-200ZYPITAMAGPitavastatin MagnesiumMedicure International IncNDACurrent
25208-200ZYPITAMAGPitavastatin MagnesiumMedicure International IncNDACurrent
25208-200ZYPITAMAGPitavastatin MagnesiumMedicure International IncNDACurrent
25208-201ZYPITAMAGPitavastatin MagnesiumMedicure International IncNDACurrent
25208-201ZYPITAMAGPitavastatin MagnesiumMedicure International IncNDACurrent
25208-201ZYPITAMAGPitavastatin MagnesiumMedicure International IncNDACurrent
25208-201ZYPITAMAGPitavastatin MagnesiumMedicure International IncNDACurrent
25208-201ZYPITAMAGPitavastatin MagnesiumMedicure International IncNDACurrent
25208-202ZYPITAMAGPitavastatin MagnesiumMedicure International IncNDACurrent
25208-202ZYPITAMAGPitavastatin MagnesiumMedicure International IncNDACurrent
25208-202ZYPITAMAGPitavastatin MagnesiumMedicure International IncNDACurrent
25208-202ZYPITAMAGPitavastatin MagnesiumMedicure International IncNDACurrent
25208-202ZYPITAMAGPitavastatin MagnesiumMedicure International IncNDACurrent
70771-1116ZYPITAMAGPitavastatin MagnesiumCadila Healthcare LimitedNDACurrent
70771-1117ZYPITAMAGPitavastatin MagnesiumCadila Healthcare LimitedNDACurrent
70771-1117ZYPITAMAGPitavastatin MagnesiumCadila Healthcare LimitedNDACurrent
70771-1117ZYPITAMAGPitavastatin MagnesiumZydus Lifesciences LimitedNDACurrent
70771-1118ZYPITAMAGPitavastatin MagnesiumCadila Healthcare LimitedNDACurrent
70771-1118ZYPITAMAGPitavastatin MagnesiumCadila Healthcare LimitedNDACurrent
70771-1118ZYPITAMAGPitavastatin MagnesiumZydus Lifesciences LimitedNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77390SUPPL 2024-02-02
77381SUPPL 2024-02-01
64719SUPPL2020-09-29
64707SUPPL2020-09-28
61856SUPPL2020-02-10
61851SUPPL2020-02-10
49652ORIG2017-09-01
49651ORIG2017-09-01
49001ORIG2017-07-17
48999ORIG2017-07-17