Application 201529

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMINJECTABLE;INJECTIONEQ 50MG BASE/2ML (EQ 25MG BASE/ML)NoNo
002METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMINJECTABLE;INJECTIONEQ 100MG BASE/4ML (EQ 25MG BASE/ML)NoNo
003METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMINJECTABLE;INJECTIONEQ 200MG BASE/8ML (EQ 25MG BASE/ML)NoNo
004METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMINJECTABLE;INJECTIONEQ 250MG BASE/10ML (EQ 25MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-466MethotrexateMethotrexateMylan Institutional LLCANDACurrent
67457-466MethotrexateMethotrexateMylan Institutional LLCANDACurrent
67457-466MethotrexateMethotrexateMylan Institutional LLCANDACurrent