FDA.reportPublic FDA data

Application 209197

Type
ANDA
Sponsor
BPI LABS 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
54288-106MelphalanMelphalan HydrochlorideBPI Labs LLCANDACurrent
54288-106MelphalanMelphalan HydrochlorideBPI Labs LLCANDACurrent
54288-106MelphalanMelphalan HydrochlorideBPI Labs LLCANDACurrent
54288-109Melphalan hydrochlorideMelphalan HydrochlorideBPI Labs LLCANDACurrent
54288-109Melphalan hydrochlorideMelphalan HydrochlorideBPI Labs LLCANDACurrent