FDA.reportPublic FDA data

Application 050753

Type
NDA
Sponsor
MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOBITOBRAMYCINSOLUTION;INHALATION300MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0494TOBITobramycinNovartis Pharmaceuticals CorporationNDACurrent
0078-0494TOBITobramycinNovartis Pharmaceuticals CorporationNDACurrent
0078-0494TOBITobramycinNovartis Pharmaceuticals CorporationNDACurrent
0781-7171TobramycinTobramycinSandoz IncNDA AUTHORIZED GENERICCurrent
0781-7171TobramycinTobramycinSandoz IncNDA AUTHORIZED GENERICCurrent
49502-345TOBITobramycinMylan Specialty L.P.NDACurrent
49502-345TOBITobramycinMylan Specialty L.P.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73470SUPPL 2023-02-13
73461SUPPL 2023-02-13
56962SUPPL2018-12-21
56987SUPPL2018-12-20
55916SUPPL2018-10-15
55892SUPPL2018-10-11
18179SUPPL2015-10-08
8187SUPPL2015-10-06
39254SUPPL2014-04-29
30450SUPPL2014-04-29
30449SUPPL2013-10-01
18178SUPPL2013-09-27
22219ORIG2010-05-25
8186SUPPL2008-10-22
30448SUPPL2002-03-21