FDA.reportPublic FDA data

Application 207080

Type
ANDA
Sponsor
DR REDDYS LABS SA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-119Tobramycin Inhalation SolutionTobramycin Inhalation SolutionNorthStar RxLLCANDACurrent
16714-119Tobramycin Inhalation SolutionTobramycin Inhalation SolutionNorthStar RxLLCANDACurrent
16714-119Tobramycin Inhalation SolutionTobramycin Inhalation SolutionNorthStar RxLLCANDACurrent
43598-605Tobramycin Inhalation SolutionTobramycin Inhalation SolutionDr. ReddyANDACurrent
43598-605Tobramycin Inhalation SolutionTobramycin Inhalation SolutionDr. ReddyANDACurrent
60940-025TobramycinTobramycinHolopack Verpackungstechnik GmbHANDACurrent