FDA.reportPublic FDA data

Application 050758

Type
NDA
Sponsor
ROCHE PALO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CELLCEPTMYCOPHENOLATE MOFETIL HYDROCHLORIDEINJECTABLE;INJECTION500MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0004-0298CellCeptMycophenolate Mofetil hydrochlorideGenentech, Inc.NDACurrent
0004-0298CellCeptMycophenolate Mofetil hydrochlorideGenentech, Inc.NDACurrent
0004-0298CellCeptMycophenolate Mofetil hydrochlorideGenentech, Inc.NDACurrent
0004-0298CellCeptMycophenolate Mofetil hydrochlorideGenentech, Inc.NDACurrent
0004-0298CellCeptMycophenolate Mofetil hydrochlorideGenentech, Inc.NDACurrent
0004-0298CellCeptMycophenolate Mofetil hydrochlorideGenentech, Inc.NDACurrent
0004-0298CellCeptMycophenolate Mofetil hydrochlorideGenentech, Inc.NDACurrent
0004-0298CellCeptMycophenolate Mofetil hydrochlorideGenentech, Inc.NDACurrent
0004-0298CellCeptMycophenolate Mofetil hydrochlorideGenentech, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82735SUPPL 2025-07-03
82707SUPPL 2025-06-30
79396SUPPL 2024-08-14
71786SUPPL2022-08-11
71785SUPPL2022-08-11
71772SUPPL2022-08-11
71243SUPPL2022-06-07
71242SUPPL2022-06-07
71241SUPPL2022-06-07
71228SUPPL2022-06-07
71227SUPPL2022-06-07
69101SUPPL2021-10-25
69100SUPPL2021-10-25
69093SUPPL2021-10-25
69092SUPPL2021-10-25
68359SUPPL2021-08-12
67157SUPPL2021-04-23
65937SUPPL2021-01-19
61304SUPPL2019-12-17
61291SUPPL2019-12-16
61290SUPPL2019-12-16
57850SUPPL2019-02-28
55307SUPPL2018-08-24
55290SUPPL2018-08-24
55287SUPPL2018-08-24
50873SUPPL2017-12-27
50764SUPPL2017-12-19
30482SUPPL2015-11-19
30481SUPPL2015-07-14
18195SUPPL2015-07-13
30480SUPPL2013-10-01
18194SUPPL2013-10-01
18193SUPPL2013-10-01
8218SUPPL2013-10-01
44520ORIG2012-09-27
30477SUPPL2012-09-27
39285SUPPL2012-06-26
8217SUPPL2012-06-26
39284SUPPL2012-06-18
30479SUPPL2012-06-12
30478SUPPL2009-11-09
39283SUPPL2009-10-14
23727ORIG2009-07-15
18192SUPPL2009-06-24
30476SUPPL2009-06-23
39282SUPPL2009-03-19
30475SUPPL2009-03-05
39281SUPPL2009-01-02
8216SUPPL2008-12-24
18191SUPPL2008-05-16
30474SUPPL2008-05-15
8214SUPPL2008-01-09
39280SUPPL2007-12-27
18190SUPPL2007-09-26
8215SUPPL2007-09-25
39279SUPPL2005-10-19
30473SUPPL2005-10-19
39278SUPPL2005-04-19
8213SUPPL2005-04-19
22227SUPPL2004-10-08
30472SUPPL2003-03-10
39277SUPPL2003-02-28
39276SUPPL2000-07-28
30471SUPPL2000-07-28
22228SUPPL2000-07-28
22226ORIG1998-08-12