FDA.reportPublic FDA data

Application 211340

Type
NDA
Sponsor
SILVERGATE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KATERZIAAMLODIPINE BENZOATESUSPENSION;ORALEQ 1MG BASE/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52652-5001KaterziaAmlodipineAzurity Pharmaceuticals, Inc.NDACurrent
52652-5001KaterziaAmlodipineAzurity Pharmaceuticals, Inc.NDACurrent
52652-5001KaterziaAmlodipineAzurity Pharmaceuticals, Inc.NDACurrent
52652-5001KaterziaAmlodipineSilvergate Pharmaceuticals, Inc.NDACurrent
52652-5001KaterziaAmlodipineAzurity Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83032SUPPL 2025-08-04
83031SUPPL 2025-08-04
61582ORIG2020-01-16
59286ORIG2019-07-09
59285ORIG2019-07-08
62866ORIG1900-01-01
62865ORIG1900-01-01