FDA.reportPublic FDA data

Application 016273

Type
NDA
Sponsor
US PHARM HOLDINGS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LASIXFUROSEMIDETABLET;ORAL40MGYesNo
002LASIXFUROSEMIDETABLET;ORAL20MGYesNo
003LASIXFUROSEMIDETABLET;ORAL80MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
30698-060LasixFUROSEMIDEValidus Pharmaceuticals LNDACurrent
30698-060LasixFUROSEMIDEValidus Pharmaceuticals LLCNDACurrent
30698-060LasixFUROSEMIDEValidus Pharmaceuticals LLCNDACurrent
30698-066LasixFUROSEMIDEValidus Pharmaceuticals LNDACurrent
30698-066LasixFUROSEMIDEValidus Pharmaceuticals LLCNDACurrent
30698-066LasixFUROSEMIDEValidus Pharmaceuticals LLCNDACurrent
30698-067LasixFUROSEMIDEValidus Pharmaceuticals LNDACurrent
30698-067LasixFUROSEMIDEValidus Pharmaceuticals LLCNDACurrent
30698-067LasixFUROSEMIDEValidus Pharmaceuticals LLCNDACurrent
70518-2030LasixFUROSEMIDEREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62207SUPPL2020-03-19
55158SUPPL2018-08-10
12983SUPPL2016-03-08
10877SUPPL2016-03-08
33152SUPPL2012-03-28
428SUPPL2012-03-28
12982SUPPL2010-10-20
33151SUPPL2010-10-18
12981SUPPL2008-10-23
427SUPPL2006-02-22