FDA.reportPublic FDA data

Application 211189

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOBRAMYCIN SULFATETOBRAMYCIN SULFATEINJECTABLE;INJECTIONEQ 1.2GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68083-312TobramycinTobramycinGland Pharma LimitedANDACurrent
68083-312TobramycinTobramycinGland Pharma LimitedANDACurrent
70700-173TobramycinTobramycinXiromed LLCANDACurrent
70700-173TobramycinTobramycinXiromed LLCANDACurrent
70700-173TobramycinTobramycinXiromed LLCANDACurrent
72266-163TobramycinTobramycinFosun Pharma USA IncANDACurrent
72266-163TobramycinTobramycinFosun Pharma USA IncANDACurrent