Application 020896
- Type
- NDA
- Sponsor
- HOFFMANN LA ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XELODA | CAPECITABINE | TABLET;ORAL | 150MG | Yes | No |
| 002 | XELODA | CAPECITABINE | TABLET;ORAL | 500MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0004-1100 | Xeloda | capecitabine | Genentech, Inc. | NDA | Current |
| 0004-1100 | Xeloda | capecitabine | Genentech, Inc. | NDA | Current |
| 0004-1100 | Xeloda | capecitabine | Genentech, Inc. | NDA | Current |
| 0004-1100 | Xeloda | capecitabine | Genentech, Inc. | NDA | Current |
| 0004-1100 | Xeloda | capecitabine | Genentech, Inc. | NDA | Current |
| 0004-1100 | Xeloda | capecitabine | Genentech, Inc. | NDA | Current |
| 0004-1101 | Xeloda | capecitabine | Genentech, Inc. | NDA | Current |
| 0004-1101 | Xeloda | capecitabine | Genentech, Inc. | NDA | Current |
| 0004-1101 | Xeloda | capecitabine | Genentech, Inc. | NDA | Current |
| 0004-1101 | Xeloda | capecitabine | Genentech, Inc. | NDA | Current |
| 0004-1101 | Xeloda | capecitabine | Genentech, Inc. | NDA | Current |
| 0004-1101 | Xeloda | capecitabine | Genentech, Inc. | NDA | Current |
| 53808-0411 | Xeloda | capecitabine | State of Florida DOH Central Pharmacy | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83670 | SUPPL | 2025-10-06 |
| 83664 | SUPPL | 2025-10-06 |
| 73669 | SUPPL | 2023-03-03 |
| 73668 | SUPPL | 2023-03-03 |
| 73667 | SUPPL | 2023-03-03 |
| 73666 | SUPPL | 2023-03-03 |
| 73665 | SUPPL | 2023-03-03 |
| 73664 | SUPPL | 2023-03-03 |
| 73663 | SUPPL | 2023-03-03 |
| 73662 | SUPPL | 2023-03-03 |
| 72903 | SUPPL | 2022-12-15 |
| 72902 | SUPPL | 2022-12-15 |
| 72901 | SUPPL | 2022-12-15 |
| 72900 | SUPPL | 2022-12-15 |
| 72899 | SUPPL | 2022-12-15 |
| 72898 | SUPPL | 2022-12-15 |
| 72897 | SUPPL | 2022-12-15 |
| 72896 | SUPPL | 2022-12-15 |
| 72892 | SUPPL | 2022-12-15 |
| 72891 | SUPPL | 2022-12-15 |
| 72890 | SUPPL | 2022-12-15 |
| 72889 | SUPPL | 2022-12-15 |
| 72888 | SUPPL | 2022-12-15 |
| 72887 | SUPPL | 2022-12-15 |
| 72886 | SUPPL | 2022-12-15 |
| 72883 | SUPPL | 2022-12-14 |
| 67566 | SUPPL | 2021-05-20 |
| 67563 | SUPPL | 2021-05-20 |
| 57871 | SUPPL | 2020-04-17 |
| 57817 | SUPPL | 2019-02-27 |
| 46204 | SUPPL | 2016-12-19 |
| 46173 | SUPPL | 2016-12-15 |
| 13688 | SUPPL | 2015-03-24 |
| 3679 | SUPPL | 2015-03-24 |
| 13687 | SUPPL | 2015-03-05 |
| 26134 | SUPPL | 2015-03-03 |
| 35588 | SUPPL | 2014-10-21 |
| 26133 | SUPPL | 2014-10-21 |
| 3678 | SUPPL | 2013-12-16 |
| 35587 | SUPPL | 2013-12-11 |
| 51283 | SUPPL | 2011-07-01 |
| 35586 | SUPPL | 2011-02-09 |
| 3677 | SUPPL | 2011-02-09 |
| 51282 | SUPPL | 2008-05-07 |
| 51281 | SUPPL | 2007-01-19 |
| 3676 | SUPPL | 2005-06-16 |
| 35585 | SUPPL | 2005-06-15 |
| 51280 | SUPPL | 2005-03-16 |
| 13684 | SUPPL | 2003-04-25 |
| 13686 | SUPPL | 2003-03-26 |
| 3675 | SUPPL | 2003-03-26 |
| 41789 | SUPPL | 2001-09-07 |
| 35584 | SUPPL | 2001-09-07 |
| 26132 | SUPPL | 2001-09-07 |
| 21048 | SUPPL | 2001-09-07 |
| 13685 | SUPPL | 2001-09-07 |
| 3674 | SUPPL | 2001-09-07 |
| 41788 | SUPPL | 2001-04-30 |
| 41787 | SUPPL | 2001-04-30 |
| 3673 | SUPPL | 2001-04-30 |
| 3672 | SUPPL | 2001-04-30 |
| 41786 | ORIG | 1998-04-30 |
| 35583 | ORIG | 1998-04-30 |
| 3671 | ORIG | 1998-04-30 |
| 63883 | ORIG | 1900-01-01 |
| 63882 | ORIG | 1900-01-01 |
| 63881 | ORIG | 1900-01-01 |
| 52406 | SUPPL | 1900-01-01 |
| 52405 | SUPPL | 1900-01-01 |
| 52404 | SUPPL | 1900-01-01 |