FDA.reportPublic FDA data

Application 209379

Type
NDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SELENIOUS ACIDSELENIOUS ACIDSOLUTION;INTRAVENOUSEQ 600MCG BASE/10ML (EQ 60MCG BASE/ML)YesYes
002SELENIOUS ACIDSELENIOUS ACIDSOLUTION;INTRAVENOUSEQ 60MCG BASE/ML (EQ 60MCG BASE/ML)YesYes
003SELENIOUS ACIDSELENIOUS ACIDSOLUTION;INTRAVENOUSEQ 12MCG BASE/2ML (EQ 6MCG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-6502Selenious AcidSelenious AcidAmerican Regent, Inc.NDACurrent
0517-6560Selenious AcidSelenious AcidAmerican Regent, Inc.NDACurrent
0517-6560Selenious AcidSelenious AcidAmerican Regent, Inc.NDACurrent
0517-6560Selenious AcidSelenious AcidAmerican Regent, Inc.NDACurrent
0517-6560Selenious AcidSelenious AcidAmerican Regent, Inc.NDACurrent
0517-6560Selenious AcidSelenious AcidAmerican Regent, Inc.NDACurrent
0517-6560Selenious AcidSelenious AcidAmerican Regent, Inc.NDACurrent
0517-6560Selenious AcidSelenious AcidAmerican Regent, Inc.NDACurrent
0517-6560Selenious AcidSelenious AcidAmerican Regent, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75372SUPPL 2023-09-08
65996SUPPL2021-01-26
65019SUPPL2020-10-23
64981SUPPL2020-10-23
61312ORIG2019-12-17
58513ORIG2019-05-02
58495ORIG2019-05-01