FDA.reportPublic FDA data

Application 201820

Type
NDA
Sponsor
CHIESI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BETHKISTOBRAMYCINSOLUTION;INHALATION300MG/4MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10122-820BETHKIStobramycinChiesi USA, Inc.NDACurrent
10122-820BETHKIStobramycinChiesi USA, Inc.NDACurrent
10122-820BETHKIStobramycinChiesi USA, Inc.NDACurrent
10122-820BETHKIStobramycinChiesi USA, Inc.NDACurrent
66993-195Tobramycin Inhalationtobramycin inhalationPrasco, LLCNDA AUTHORIZED GENERICCurrent
66993-195Tobramycin Inhalationtobramycin inhalationPrasco, LLCNDA AUTHORIZED GENERICCurrent
66993-195Tobramycin Inhalationtobramycin inhalationPrasco, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73477SUPPL 2023-02-13
73464SUPPL 2023-02-13
61224SUPPL2019-12-11
61201SUPPL2019-12-10
48611SUPPL2017-06-01
48603SUPPL2017-05-31
24402ORIG2013-09-03
22862ORIG2013-09-03
32140ORIG2012-10-16
40089ORIG2012-10-15
51575ORIG1900-01-01
51574ORIG1900-01-01
51573ORIG1900-01-01