FDA.reportPublic FDA data

Application 209360

Type
NDA
Sponsor
LA JOLLA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GIAPREZAANGIOTENSIN II ACETATESOLUTION;INTRAVENOUSEQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)YesYes
002GIAPREZAANGIOTENSIN II ACETATESOLUTION;INTRAVENOUSEQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)YesNo
003GIAPREZAANGIOTENSIN II ACETATESOLUTION;INTRAVENOUSEQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68547-005Giaprezaangiotensin IILa Jolla Pharmaceutical CompanyNDACurrent
68547-005Giaprezaangiotensin IILa Jolla Pharmaceutical CompanyNDACurrent
68547-501Giaprezaangiotensin IILa Jolla Pharmaceutical CompanyNDACurrent
68547-501Giaprezaangiotensin IILa Jolla Pharmaceutical CompanyNDACurrent
68547-501Giaprezaangiotensin IILa Jolla Pharmaceutical CompanyNDACurrent
68547-501Giaprezaangiotensin IILa Jolla Pharmaceutical CompanyNDACurrent
68547-501Giaprezaangiotensin IILa Jolla Pharmaceutical CompanyNDACurrent
68547-501Giaprezaangiotensin IILa Jolla Pharmaceutical CompanyNDACurrent
68547-501Giaprezaangiotensin IILa Jolla Pharmaceutical CompanyNDACurrent
68547-501Giaprezaangiotensin IILa Jolla Pharmaceutical CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52233ORIG2018-01-31
50923ORIG2017-12-27
50866ORIG2017-12-26