FDA.reportPublic FDA data

Application 022249

Type
NDA
Sponsor
CEPHALON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TREANDABENDAMUSTINE HYDROCHLORIDEPOWDER;IV (INFUSION)100MG/VIALYesYes
002TREANDABENDAMUSTINE HYDROCHLORIDEPOWDER;IV (INFUSION)25MG/VIALYesYes
003TREANDABENDAMUSTINE HYDROCHLORIDESOLUTION;IV (INFUSION)45MG/0.5ML (90MG/ML)YesNo
004TREANDABENDAMUSTINE HYDROCHLORIDESOLUTION;IV (INFUSION)180MG/2ML (90MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63459-390TREANDABendamustine HydrochlorideCephalon, Inc.NDACurrent
63459-390TREANDABendamustine HydrochlorideCephalon, LLCNDACurrent
63459-390TREANDABendamustine HydrochlorideCephalon, Inc.NDACurrent
63459-390TREANDABendamustine HydrochlorideCephalon, Inc.NDACurrent
63459-390TREANDABendamustine HydrochlorideCephalon, Inc.NDACurrent
63459-390TREANDABendamustine HydrochlorideCephalon, Inc.NDACurrent
63459-391TREANDABendamustine HydrochlorideCephalon, Inc.NDACurrent
63459-391TREANDABendamustine HydrochlorideCephalon, LLCNDACurrent
63459-391TREANDABendamustine HydrochlorideCephalon, Inc.NDACurrent
63459-391TREANDABendamustine HydrochlorideCephalon, Inc.NDACurrent
63459-391TREANDABendamustine HydrochlorideCephalon, Inc.NDACurrent
63459-391TREANDABendamustine HydrochlorideCephalon, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72557SUPPL2022-11-03
72480SUPPL2022-10-27
67772SUPPL2021-06-14
67765SUPPL2021-06-11
62854SUPPL2020-05-08
61031SUPPL2019-11-22
61013SUPPL2019-11-22
50836SUPPL2017-12-22
50782SUPPL2017-12-20
45566SUPPL2016-10-20
45906SUPPL2016-10-19
42464SUPPL2016-07-27
42463SUPPL2016-07-27
38422SUPPL2015-11-12
29442SUPPL2015-11-09
7088SUPPL2015-09-04
38423SUPPL2015-09-02
7087SUPPL2015-03-11
38421SUPPL2015-03-10
42462SUPPL2014-08-01
17120SUPPL2013-09-17
29441SUPPL2013-08-29
17119SUPPL2013-08-29
17118SUPPL2012-06-27
7086SUPPL2012-06-27
51261SUPPL2011-07-07
7085SUPPL2010-12-28
38420SUPPL2010-12-26
29440SUPPL2010-03-04
17117SUPPL2010-03-03
51260SUPPL2010-01-23
51259SUPPL2010-01-19
38418SUPPL2009-05-11
29439SUPPL2009-05-06
38419SUPPL2009-04-28
7084SUPPL2009-04-27
44714ORIG2008-05-08
21969ORIG2008-05-08
29438ORIG2008-03-21
38417ORIG2008-03-20
53186SUPPL1900-01-01
53185SUPPL1900-01-01