FDA.reportPublic FDA data

Application 203585

Type
NDA
Sponsor
TEVA PHARMS INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYNRIBOOMACETAXINE MEPESUCCINATEPOWDER;SUBCUTANEOUS3.5MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63459-177SYNRIBOOmacetaxine MepesuccinateCephalon, Inc.NDACurrent
63459-177SYNRIBOOmacetaxine MepesuccinateCephalon, Inc.NDACurrent
63459-177SYNRIBOOmacetaxine MepesuccinateCephalon, Inc.NDACurrent
63459-177SYNRIBOOmacetaxine MepesuccinateCephalon, Inc.NDACurrent
63459-177SYNRIBOOmacetaxine MepesuccinateCephalon, Inc.NDACurrent
63459-177SYNRIBOOmacetaxine MepesuccinateCephalon, LLCNDACurrent
63459-177SYNRIBOOmacetaxine MepesuccinateCephalon, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68386SUPPL2021-08-16
68384SUPPL2021-08-16
67475SUPPL2021-05-12
61103SUPPL2019-11-29
61102SUPPL2019-11-29
61077SUPPL2019-11-27
57537SUPPL2019-02-13
57342SUPPL2019-01-25
48805SUPPL2017-06-22
48796SUPPL2017-06-22
19487SUPPL2016-06-17
32450SUPPL2016-06-15
32449SUPPL2014-05-06
40315SUPPL2014-05-02
32448SUPPL2014-02-12
19486SUPPL2014-02-11
43441ORIG2012-11-28
24441ORIG2012-11-28
32447ORIG2012-10-29
40314ORIG2012-10-26