FDA.reportPublic FDA data

Application 207383

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEMSIROLIMUSTEMSIROLIMUSSOLUTION;INTRAVENOUS25MG/ML (25MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65219-200TemsirolimusTemsirolimusFresenius Kabi USA, LLCANDACurrent
68083-202TemsirolimusTemsirolimus InjectionGland Pharma LimitedANDACurrent
68083-202TemsirolimusTemsirolimus InjectionGland Pharma LimitedANDACurrent
72611-785TemsirolimusTemsirolimus InjectionAlmaject, Inc.ANDACurrent
72611-785TemsirolimusTemsirolimus InjectionAlmaject, Inc.ANDACurrent
72611-785TemsirolimusTemsirolimus InjectionAlmaject, Inc.ANDACurrent