FDA.reportPublic FDA data

Application 210848

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOCETAXELDOCETAXELINJECTABLE;INJECTION80MG/8ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-532DocetaxelDOCETAXEL ANHYDROUSMylan Institutional LLCANDACurrent
67457-532DocetaxelDOCETAXEL ANHYDROUSMylan Institutional LLCANDACurrent
67457-532DocetaxelDOCETAXEL ANHYDROUSMylan Institutional LLCANDACurrent
72078-040DocetaxelDOCETAXEL ANHYDROUSMylan Institutional LLCANDACurrent