Application 201379

Type
ANDA
Sponsor
SAGENT PHARMS INC

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
25021-221Melphalan HydrochlorideMelphalan HydrochlorideSagent PharmaceuticalsANDACurrent
25021-221Melphalan HydrochlorideMelphalan HydrochlorideSagent PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47447ORIG2017-03-03