FDA.reportPublic FDA data

Application 212848

Type
ANDA
Sponsor
ALKEM LABS LTD

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
60940-027TobramycinTobramycinHolopack Verpackungstechnik GmbHANDACurrent
67877-678TobramycinTobramycinAscend Laboratories, LLCANDACurrent
67877-678TobramycinTobramycinAscend Laboratories, LLCANDACurrent