FDA.reportPublic FDA data

Application 009330

Type
NDA
Sponsor
COVIS PHARMA BV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002LANOXINDIGOXININJECTABLE;INJECTION0.25MG/MLYesYes
004LANOXIN PEDIATRICDIGOXININJECTABLE;INJECTION0.1MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70515-260LANOXINdigoxinCovis Pharma US, IncNDACurrent
70515-260LANOXINdigoxinCovis Pharma US, IncNDACurrent
70515-260LANOXINdigoxinCovis PharmaNDACurrent
70515-260LANOXINdigoxinCovis PharmaNDACurrent
70515-260LANOXINdigoxinCovis PharmaNDACurrent
70515-261LANOXINdigoxinCovis PharmaNDACurrent
70515-261LANOXINdigoxinCovis Pharma US, IncNDACurrent
70515-261LANOXINdigoxinCovis Pharma US, IncNDACurrent
70515-261LANOXINdigoxinCovis PharmaNDACurrent
70515-262LANOXINdigoxinCovis PharmaNDACurrent
70515-262LANOXINdigoxinCovis PharmaNDACurrent
70515-262LANOXINdigoxinCovis PharmaNDACurrent
70515-262LANOXINdigoxinCovis Pharma US, IncNDACurrent
70515-262LANOXINdigoxinCovis Pharma US, IncNDACurrent
70515-263LANOXINdigoxinCovis PharmaNDACurrent
70515-263LANOXINdigoxinCovis Pharma US, IncNDACurrent
70515-263LANOXINdigoxinCovis Pharma US, IncNDACurrent
70515-263LANOXINdigoxinCovis PharmaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83726SUPPL 2025-10-14
78861SUPPL 2024-09-16
78864SUPPL 2024-06-24
72575SUPPL2022-11-07
72549SUPPL2022-11-03
56005SUPPL2018-10-17
55729SUPPL2018-10-01
55344SUPPL2018-08-28
55302SUPPL2018-08-24
46054SUPPL2016-12-06
46019SUPPL2016-12-05
32997SUPPL2015-07-30
187SUPPL2015-07-29
11874SUPPL2013-05-22
10726SUPPL2013-05-21
11873SUPPL2011-11-16
10725SUPPL2011-11-14
186SUPPL2010-03-18
32996SUPPL2010-02-16
185SUPPL2002-06-17
20021SUPPL2001-09-14