FDA.reportPublic FDA data

Application 208194

Type
NDA
Sponsor
EAGLE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENDEKABENDAMUSTINE HYDROCHLORIDESOLUTION;IV (INFUSION)100MG/4ML (25MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63459-348Bendekabendamustine hydrochlorideTeva Pharmaceuticals USA, Inc.NDACurrent
63459-348Bendekabendamustine hydrochlorideTeva Pharmaceuticals USA, Inc.NDACurrent
63459-348Bendekabendamustine hydrochlorideTeva Pharmaceuticals USA, Inc.NDACurrent
63459-348Bendekabendamustine hydrochlorideTeva Pharmaceuticals USA, Inc.NDACurrent
63459-348Bendekabendamustine hydrochlorideTeva Pharmaceuticals USA, Inc.NDACurrent
63459-348BENDEKAbendamustine hydrochlorideTeva Pharmaceuticals USA, Inc.NDACurrent
63459-348Bendekabendamustine hydrochlorideTeva Pharmaceuticals USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77228SUPPL 2024-01-16
77212SUPPL 2024-01-16
69023SUPPL2021-10-19
69000SUPPL2021-10-15
61244SUPPL2019-12-12
60826SUPPL2019-11-13
60572SUPPL2019-10-15
60507SUPPL2019-10-10
55089SUPPL2018-08-03
55065SUPPL2018-07-31
52652SUPPL2018-02-15
52651SUPPL2018-02-15
47180SUPPL2017-02-13
47169SUPPL2017-02-10
40623SUPPL2016-08-02
40624SUPPL2016-06-27
23053ORIG2016-06-27
32897SUPPL2016-06-24
10649SUPPL2016-06-24
10648ORIG2015-12-09
19987ORIG2015-12-08