FDA.reportPublic FDA data

Application 205574

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENDAMUSTINE HYDROCHLORIDEBENDAMUSTINE HYDROCHLORIDEPOWDER;IV (INFUSION)25MG/VIALNoNo
002BENDAMUSTINE HYDROCHLORIDEBENDAMUSTINE HYDROCHLORIDEPOWDER;IV (INFUSION)100MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-250bendamustine hydrochloridebendamustine hydrochlorideAccord Healthcare, Inc.ANDACurrent
16729-251bendamustine hydrochloridebendamustine hydrochlorideAccord Healthcare, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73129ORIG2023-01-10
65092ORIG2020-10-30
40482ORIG2016-05-26
32690ORIG2016-05-20
32689ORIG2015-12-08