FDA.reportPublic FDA data

Application 089343

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMINJECTABLE;INJECTIONEQ 250MG BASE/10ML (EQ 25MG BASE/ML)NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9516MethotrexateMethotrexateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9516MethotrexateMethotrexateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9516MethotrexateMethotrexateHikma Pharmaceuticals USA Inc.ANDACurrent