Application 050759
- Type
- NDA
- Sponsor
- ROCHE PALO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CELLCEPT | MYCOPHENOLATE MOFETIL | SUSPENSION;ORAL | 200MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0004-0261 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
| 0004-0261 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
| 0004-0261 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
| 0004-0261 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
| 0004-0261 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
| 0004-0261 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
| 0004-0261 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
| 0004-0261 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
| 0004-0261 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82733 | SUPPL | 2025-07-03 |
| 82708 | SUPPL | 2025-06-30 |
| 79397 | SUPPL | 2024-08-14 |
| 71788 | SUPPL | 2022-08-11 |
| 71787 | SUPPL | 2022-08-11 |
| 71773 | SUPPL | 2022-08-11 |
| 71246 | SUPPL | 2022-06-07 |
| 71245 | SUPPL | 2022-06-07 |
| 71244 | SUPPL | 2022-06-07 |
| 71230 | SUPPL | 2022-06-07 |
| 71229 | SUPPL | 2022-06-07 |
| 69103 | SUPPL | 2021-10-25 |
| 69102 | SUPPL | 2021-10-25 |
| 69095 | SUPPL | 2021-10-25 |
| 69094 | SUPPL | 2021-10-25 |
| 68361 | SUPPL | 2021-08-12 |
| 68360 | SUPPL | 2021-08-12 |
| 67158 | SUPPL | 2021-04-23 |
| 65939 | SUPPL | 2021-01-19 |
| 61305 | SUPPL | 2019-12-17 |
| 61293 | SUPPL | 2019-12-16 |
| 61292 | SUPPL | 2019-12-16 |
| 57851 | SUPPL | 2019-02-28 |
| 57842 | SUPPL | 2019-02-28 |
| 55308 | SUPPL | 2018-08-24 |
| 55289 | SUPPL | 2018-08-24 |
| 55288 | SUPPL | 2018-08-24 |
| 50874 | SUPPL | 2017-12-27 |
| 50765 | SUPPL | 2017-12-19 |
| 30491 | SUPPL | 2015-11-19 |
| 8228 | SUPPL | 2015-07-14 |
| 39293 | SUPPL | 2015-07-13 |
| 30490 | SUPPL | 2013-10-01 |
| 8227 | SUPPL | 2013-10-01 |
| 24039 | ORIG | 2012-09-27 |
| 8225 | SUPPL | 2012-09-27 |
| 30489 | SUPPL | 2012-06-26 |
| 18201 | SUPPL | 2012-06-26 |
| 18200 | SUPPL | 2012-06-18 |
| 8226 | SUPPL | 2012-06-12 |
| 30488 | SUPPL | 2009-11-09 |
| 39292 | SUPPL | 2009-10-14 |
| 44206 | ORIG | 2009-07-15 |
| 39291 | SUPPL | 2009-06-24 |
| 8224 | SUPPL | 2009-06-23 |
| 18199 | SUPPL | 2009-03-19 |
| 8223 | SUPPL | 2009-03-05 |
| 39290 | SUPPL | 2009-01-02 |
| 30487 | SUPPL | 2008-12-24 |
| 39289 | SUPPL | 2008-05-16 |
| 8222 | SUPPL | 2008-05-15 |
| 30485 | SUPPL | 2008-01-09 |
| 18198 | SUPPL | 2007-12-27 |
| 39288 | SUPPL | 2007-09-26 |
| 30486 | SUPPL | 2007-09-25 |
| 39287 | SUPPL | 2005-10-19 |
| 30484 | SUPPL | 2005-10-19 |
| 42721 | ORIG | 2005-07-11 |
| 22229 | SUPPL | 2004-10-08 |
| 8221 | SUPPL | 2003-03-10 |
| 39286 | SUPPL | 2003-02-28 |
| 42722 | SUPPL | 2000-12-22 |
| 30483 | SUPPL | 2000-12-22 |
| 18196 | SUPPL | 2000-12-22 |
| 42723 | SUPPL | 2000-07-28 |
| 18197 | SUPPL | 2000-07-28 |
| 8220 | SUPPL | 2000-07-28 |
| 8219 | ORIG | 1998-10-01 |