FDA.reportPublic FDA data

Application 210947

Type
ANDA
Sponsor
INGENUS PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MELPHALAN HYDROCHLORIDEMELPHALAN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 50MG BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50742-477MELPHALAN HYDROCHLORIDEMELPHALAN HYDROCHLORIDEIngenus Pharmaceuticals, LLCANDACurrent
50742-477MELPHALAN HYDROCHLORIDEMELPHALAN HYDROCHLORIDEIngenus Pharmaceuticals, LLCANDACurrent
70700-278MELPHALAN HYDROCHLORIDEMELPHALAN HYDROCHLORIDEXiromed, LLCANDACurrent