FDA.reportPublic FDA data

Application 205433

Type
NDA
Sponsor
PULMOFLOW INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KITABIS PAKTOBRAMYCINSOLUTION;INHALATION300MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24492-850Kitabis PakTobramycinPari Respiratory EquipmentNDACurrent
24492-850Kitabis PakTobramycinPari Respiratory Equipment, Inc.NDACurrent
24492-850Kitabis PakTobramycinPari Respiratory EquipmentNDACurrent
24492-850Kitabis PakTobramycinPari Respiratory Equipment, Inc.NDACurrent
24492-850Kitabis PakTobramycinPari Respiratory EquipmentNDACurrent
70644-899TobramycinTobramycinGenericus, Inc.NDA AUTHORIZED GENERICCurrent
70644-899TobramycinTobramycinGenericus, Inc.NDA AUTHORIZED GENERICCurrent
70644-899TobramycinTobramycinGenericus, Inc.NDA AUTHORIZED GENERICCurrent
70644-899TobramycinTobramycinGenericus, Inc.NDA AUTHORIZED GENERICCurrent
70644-899TobramycinTobramycinGenericus, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73984SUPPL 2023-04-12
73971SUPPL 2023-04-11
73476SUPPL 2023-02-13
73466SUPPL 2023-02-13
61206SUPPL2019-12-10
61200SUPPL2019-12-09
22987ORIG2015-04-06
32671ORIG2014-12-03
19644ORIG2014-12-03
32672ORIG2014-08-27