FDA.reportPublic FDA data

Application 208401

Type
NDA
Sponsor
SILVERGATE PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52652-3001QbrelislisinoprilSilvergate Pharmaceuticals, Inc.NDACurrent
52652-3001QbrelislisinoprilAzurity Pharmaceuticals, Inc.NDACurrent
52652-3001QbrelislisinoprilAzurity Pharmaceuticals, Inc.NDACurrent
52652-3001QbrelislisinoprilSilvergate Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49185SUPPL2017-08-02
49153SUPPL2017-07-31
46455ORIG2016-12-21
19993ORIG2016-08-02
10654ORIG2016-08-02