FDA.reportPublic FDA data

Application 210040

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHOTREXATE SODIUMMETHOTREXATE SODIUMTABLET;ORALEQ 2.5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-505MethotrexateMethotrexateAvKAREANDACurrent
42291-505MethotrexateMethotrexateAvKAREANDACurrent
50268-527MethotrexateMethotrexateAvPAKANDACurrent
50268-527MethotrexateMethotrexateAvPAKANDACurrent
69238-1423MethotrexateMethotrexateAmneal Pharmaceuticals LLCANDACurrent
69238-1423MethotrexateMethotrexateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1423MethotrexateMethotrexateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1423MethotrexateMethotrexateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1423MethotrexateMethotrexateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1423MethotrexateMethotrexateAmneal Pharmaceuticals NY LLCANDACurrent