FDA.reportPublic FDA data

Application 208686

Type
NDA
Sponsor
SILVERGATE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPANEDENALAPRIL MALEATESOLUTION;ORAL1MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52652-4001Epanedenalapril maleateAzurity Pharmaceuticals, Inc.NDACurrent
52652-4001Epanedenalapril maleateSilvergate Pharmaceuticals, Inc.NDACurrent
52652-4001Epanedenalapril maleateSilvergate Pharmaceuticals, Inc.NDACurrent
52652-4001Epanedenalapril maleateAzurity Pharmaceuticals, Inc.NDACurrent
69238-2141Enalapril MaleateEnalaprilAmneal Pharmaceuticals NY LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49151SUPPL2017-07-31
46971ORIG2017-01-24
46007ORIG2016-12-02
45496ORIG2016-09-22