FDA.reportPublic FDA data

Application 050722

Type
NDA
Sponsor
ROCHE PALO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CELLCEPTMYCOPHENOLATE MOFETILCAPSULE;ORAL250MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0004-0259CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
0004-0259CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
0004-0259CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
0004-0259CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
0004-0259CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
0004-0259CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
0004-0259CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
0004-0259CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
0004-0259CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
21695-171CellCeptMycophenolate MofetilRebel Distributors CorpNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82737SUPPL 2025-07-03
82705SUPPL 2025-06-30
79394SUPPL 2024-08-14
71782SUPPL2022-08-11
71781SUPPL2022-08-11
71770SUPPL2022-08-11
71236SUPPL2022-06-07
71235SUPPL2022-06-07
71234SUPPL2022-06-07
71224SUPPL2022-06-07
71223SUPPL2022-06-07
69097SUPPL2021-10-25
69096SUPPL2021-10-25
69089SUPPL2021-10-25
69088SUPPL2021-10-25
68357SUPPL2021-08-12
67155SUPPL2021-04-23
65936SUPPL2021-01-19
61302SUPPL2019-12-17
61287SUPPL2019-12-16
61286SUPPL2019-12-16
57848SUPPL2019-02-28
57840SUPPL2019-02-28
55305SUPPL2018-08-24
55292SUPPL2018-08-24
55285SUPPL2018-08-24
50871SUPPL2017-12-27
50762SUPPL2017-12-19
30373SUPPL2015-11-19
8115SUPPL2015-07-14
39191SUPPL2015-07-13
39190SUPPL2013-10-01
30372SUPPL2013-10-01
18121SUPPL2013-10-01
8114SUPPL2013-10-01
44518ORIG2012-09-27
8112SUPPL2012-09-27
18120SUPPL2012-06-26
8113SUPPL2012-06-26
18119SUPPL2012-06-18
30371SUPPL2012-06-12
30370SUPPL2009-11-09
18118SUPPL2009-10-14
23724ORIG2009-07-15
39189SUPPL2009-06-24
30369SUPPL2009-06-23
18117SUPPL2009-03-19
30368SUPPL2009-03-05
39188SUPPL2009-01-02
8111SUPPL2008-12-24
18116SUPPL2008-05-16
8110SUPPL2008-05-15
8109SUPPL2008-01-09
18115SUPPL2007-12-27
39187SUPPL2007-09-26
30367SUPPL2007-09-25
39186SUPPL2005-10-19
8108SUPPL2005-10-19
42698SUPPL2004-10-08
22201SUPPL2004-10-08
22200SUPPL2004-10-08
30366SUPPL2003-03-10
18114SUPPL2003-02-28
22202SUPPL2000-12-22
39185SUPPL2000-12-20
8107SUPPL2000-12-20
42697SUPPL2000-07-28
39184SUPPL2000-07-28
30365SUPPL2000-07-28
57446ORIG1998-06-12