Application 050723
- Type
- NDA
- Sponsor
- ROCHE PALO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CELLCEPT | MYCOPHENOLATE MOFETIL | TABLET;ORAL | 500MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0004-0260 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
| 0004-0260 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
| 0004-0260 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
| 0004-0260 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
| 0004-0260 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
| 0004-0260 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
| 0004-0260 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
| 0004-0260 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
| 0004-0260 | CellCept | Mycophenolate Mofetil | Genentech, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82736 | SUPPL | 2025-07-03 |
| 82706 | SUPPL | 2025-06-30 |
| 79395 | SUPPL | 2024-08-14 |
| 71784 | SUPPL | 2022-08-11 |
| 71783 | SUPPL | 2022-08-11 |
| 71771 | SUPPL | 2022-08-11 |
| 71239 | SUPPL | 2022-06-07 |
| 71238 | SUPPL | 2022-06-07 |
| 71237 | SUPPL | 2022-06-07 |
| 71226 | SUPPL | 2022-06-07 |
| 71225 | SUPPL | 2022-06-07 |
| 69099 | SUPPL | 2021-10-25 |
| 69098 | SUPPL | 2021-10-25 |
| 69091 | SUPPL | 2021-10-25 |
| 69090 | SUPPL | 2021-10-25 |
| 68358 | SUPPL | 2021-08-12 |
| 67156 | SUPPL | 2021-04-23 |
| 65938 | SUPPL | 2021-01-19 |
| 61303 | SUPPL | 2019-12-17 |
| 61289 | SUPPL | 2019-12-16 |
| 61288 | SUPPL | 2019-12-16 |
| 57849 | SUPPL | 2019-02-28 |
| 57841 | SUPPL | 2019-02-28 |
| 55306 | SUPPL | 2018-08-24 |
| 55291 | SUPPL | 2018-08-24 |
| 55286 | SUPPL | 2018-08-24 |
| 50872 | SUPPL | 2017-12-27 |
| 50763 | SUPPL | 2017-12-19 |
| 30383 | SUPPL | 2015-11-19 |
| 8124 | SUPPL | 2015-07-14 |
| 39200 | SUPPL | 2015-07-13 |
| 39199 | SUPPL | 2013-10-01 |
| 30382 | SUPPL | 2013-10-01 |
| 18128 | SUPPL | 2013-10-01 |
| 8123 | SUPPL | 2013-10-01 |
| 44519 | ORIG | 2012-09-27 |
| 30378 | SUPPL | 2012-09-27 |
| 18127 | SUPPL | 2012-06-26 |
| 8122 | SUPPL | 2012-06-26 |
| 18126 | SUPPL | 2012-06-18 |
| 30381 | SUPPL | 2012-06-12 |
| 30379 | SUPPL | 2009-11-20 |
| 30380 | SUPPL | 2009-11-09 |
| 18125 | SUPPL | 2009-10-14 |
| 44205 | ORIG | 2009-07-15 |
| 39198 | SUPPL | 2009-06-24 |
| 8121 | SUPPL | 2009-06-23 |
| 18124 | SUPPL | 2009-03-19 |
| 8120 | SUPPL | 2009-03-05 |
| 18123 | SUPPL | 2009-01-02 |
| 30377 | SUPPL | 2008-12-24 |
| 39197 | SUPPL | 2008-05-16 |
| 30376 | SUPPL | 2008-05-15 |
| 30375 | SUPPL | 2008-01-09 |
| 18122 | SUPPL | 2007-12-27 |
| 39196 | SUPPL | 2007-09-26 |
| 8119 | SUPPL | 2007-09-25 |
| 39195 | SUPPL | 2005-10-19 |
| 8118 | SUPPL | 2005-10-19 |
| 22203 | SUPPL | 2004-10-08 |
| 8117 | SUPPL | 2003-03-10 |
| 39194 | SUPPL | 2003-02-28 |
| 42699 | SUPPL | 2000-12-22 |
| 39192 | SUPPL | 2000-12-22 |
| 30374 | SUPPL | 2000-12-22 |
| 39193 | SUPPL | 2000-07-28 |
| 22204 | SUPPL | 2000-07-28 |
| 8116 | SUPPL | 2000-07-28 |