FDA.reportPublic FDA data

Application 021248

Type
NDA
Sponsor
CEPHALON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRISENOXARSENIC TRIOXIDEINJECTABLE;INJECTION1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002TRISENOXARSENIC TRIOXIDEINJECTABLE;INJECTION2MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63459-600TrisenoxArsenic TrioxideCephalon, Inc.NDACurrent
63459-600TrisenoxArsenic TrioxideCephalon, Inc.NDACurrent
63459-600TrisenoxArsenic TrioxideCephalon, Inc.NDACurrent
63459-601TrisenoxArsenic TrioxideCephalon, LLCNDACurrent
63459-601TrisenoxArsenic TrioxideCephalon, Inc.NDACurrent
63459-601TrisenoxArsenic TrioxideCephalon, Inc.NDACurrent
63459-601TrisenoxArsenic TrioxideCephalon, Inc.NDACurrent
63459-601TrisenoxArsenic TrioxideCephalon, Inc.NDACurrent
63459-601TrisenoxArsenic TrioxideCephalon, Inc.NDACurrent
63459-601TrisenoxArsenic TrioxideCephalon, Inc.NDACurrent
63459-601TrisenoxArsenic TrioxideCephalon, Inc.NDACurrent
63459-601TrisenoxArsenic TrioxideCephalon, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64959SUPPL2020-10-21
64951SUPPL2020-10-21
59154SUPPL2019-06-21
59147SUPPL2019-06-21
51070SUPPL2018-01-17
51058SUPPL2018-01-17
4756SUPPL2015-02-24
14729SUPPL2015-02-23
36449SUPPL2010-07-30
14728SUPPL2010-07-30
27197SUPPL2010-07-28
4755SUPPL2010-07-28
42052ORIG2001-07-12
27196ORIG2000-09-25
14727ORIG2000-09-25