FDA.reportPublic FDA data

Application 205436

Type
NDA
Sponsor
CUBIST PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIVEXTROTEDIZOLID PHOSPHATEPOWDER;INTRAVENOUS200MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67919-040SIVEXTROtedizolid phosphateMerck Sharp & Dohme Corp.NDACurrent
67919-040SIVEXTROtedizolid phosphateMerck Sharp & Dohme Corp.NDACurrent
67919-040SIVEXTROtedizolid phosphateMerck Sharp & Dohme Corp.NDACurrent
67919-040SIVEXTROtedizolid phosphateMerck Sharp & Dohme LLCNDACurrent
67919-040SIVEXTROtedizolid phosphateMerck Sharp & Dohme LLCNDACurrent
67919-040SIVEXTROtedizolid phosphateMerck Sharp & Dohme LLCNDACurrent
67919-040SIVEXTROtedizolid phosphateMerck Sharp & Dohme Corp.NDACurrent
67919-040SIVEXTROtedizolid phosphateMerck Sharp & Dohme Corp.NDACurrent
67919-040SIVEXTROtedizolid phosphateMerck Sharp & Dohme Corp.NDACurrent
72000-320SIVEXTROtedizolid phosphateNabriva Therapeutics US, Inc.NDACurrent
72000-320SIVEXTROtedizolid phosphateNabriva Therapeutics US, Inc.NDACurrent
72000-320SIVEXTROtedizolid phosphateNabriva Therapeutics US, Inc.NDACurrent
72000-320SIVEXTROtedizolid phosphateNabriva Therapeutics US, Inc.NDACurrent
72000-320SIVEXTROtedizolid phosphateNabriva Therapeutics US, Inc.NDACurrent
72000-320SIVEXTROtedizolid phosphateNabriva Therapeutics US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85276SUPPL 2026-03-06
85207SUPPL 2026-03-03
81885SUPPL 2025-04-08
81828SUPPL 2025-04-07
69355SUPPL2021-11-18
69347SUPPL2021-11-18
65029SUPPL2020-10-27
65016SUPPL2020-10-23
63674SUPPL2020-06-23
63661SUPPL2020-06-22
59959SUPPL2019-09-11
59961SUPPL2019-09-10
57979SUPPL2019-03-13
57933SUPPL2019-03-08
49478SUPPL2017-08-21
49476SUPPL2017-08-21
49432SUPPL2017-08-16
49431SUPPL2017-08-16
45803SUPPL2016-11-04
45736SUPPL2016-10-31
19647SUPPL2015-03-09
10450SUPPL2015-03-06
43489ORIG2014-10-10
24495ORIG2014-10-10
40470ORIG2014-06-23
10449ORIG2014-06-23