FDA.reportPublic FDA data

Application 040843

Type
ANDA
Sponsor
PHARMACHEMIE BV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/40ML (EQ 25MG BASE/ML)NoNo
002METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMINJECTABLE;INJECTIONEQ 50MG BASE/2ML (EQ 25MG BASE/ML)NoNo
003METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMINJECTABLE;INJECTIONEQ 100MG BASE/4ML (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
0703-3671MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3671MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3671MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3671MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3671MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3671MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3671MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3675MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3675MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3675MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3675MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3675MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3675MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3675MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3678MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3678MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3678MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3678MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3678MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3678MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3678MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3678MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3678MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3678MethotrexateMethotrexateTeva Parenteral Medicines, Inc.ANDACurrent