FDA.reportPublic FDA data

Application 022285

Type
NDA
Sponsor
UCB INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KEPPRA XRLEVETIRACETAMTABLET, EXTENDED RELEASE;ORAL500MGYesNo
002KEPPRA XRLEVETIRACETAMTABLET, EXTENDED RELEASE;ORAL750MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50474-598KeppralevetiracetamUCB, Inc.NDACurrent
50474-598KeppralevetiracetamUCB, Inc.NDACurrent
50474-598KeppralevetiracetamUCB, Inc.NDACurrent
50474-598KeppralevetiracetamUCB, Inc.NDACurrent
50474-598KeppralevetiracetamUCB, Inc.NDACurrent
50474-599KeppralevetiracetamUCB, Inc.NDACurrent
50474-599KeppralevetiracetamUCB, Inc.NDACurrent
50474-599KeppralevetiracetamUCB, Inc.NDACurrent
50474-599KeppralevetiracetamUCB, Inc.NDACurrent
50474-599KeppralevetiracetamUCB, Inc.NDACurrent
65084-460KeppralevetiracetamMckesson Rxpak IncNDACurrent
65084-461KeppralevetiracetamMckesson Rxpak IncNDACurrent
70518-2109KeppralevetiracetamREMEDYREPACK INC.NDACurrent
70518-2109KeppralevetiracetamREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77821SUPPL 2024-03-13
77793SUPPL 2024-03-13
77792SUPPL 2024-03-13
75140SUPPL 2023-08-18
75120SUPPL 2023-08-18
64809SUPPL2020-10-02
64808SUPPL2020-10-02
64780SUPPL2020-10-01
60655SUPPL2019-10-24
60651SUPPL2019-10-24
60649SUPPL2019-10-24
50219SUPPL2017-10-30
50173SUPPL2017-10-25
48143SUPPL2017-04-27
48106SUPPL2017-04-25
45763SUPPL2016-11-01
45705SUPPL2016-10-28
29527SUPPL2016-04-08
17198SUPPL2016-04-07
29524SUPPL2015-03-12
17196SUPPL2015-03-12
29526SUPPL2014-08-11
17197SUPPL2014-08-08
38503SUPPL2014-08-04
29525SUPPL2014-08-04
7176SUPPL2014-03-11
7175SUPPL2014-03-11
38504SUPPL2014-03-10
38502SUPPL2014-03-10
38501SUPPL2013-07-30
38500SUPPL2013-07-30
29523SUPPL2013-07-26
7173SUPPL2013-07-26
7174SUPPL2011-08-12
38499SUPPL2009-05-12
38498SUPPL2009-05-12
7172SUPPL2009-05-04
7171SUPPL2009-05-04
7170SUPPL2009-02-18
38497SUPPL2009-02-13
42478ORIG2009-01-06
24274ORIG2009-01-06
44180ORIG2008-09-19
38496ORIG2008-09-16
7169ORIG2008-09-16
51297SUPPL1900-01-01
51296SUPPL1900-01-01
51295SUPPL1900-01-01
51294SUPPL1900-01-01