Application 103705
- Type
- BLA
- Sponsor
- GENENTECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RITUXAN | RITUXIMAB | SOLUTION;INTRAVENOUS | 100MG/10ML (10MG/ML) | No | No |
| 002 | RITUXAN | RITUXIMAB | SOLUTION;INTRAVENOUS | 500MG/50ML (10MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50242-051 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-051 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-051 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-051 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-051 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-051 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-051 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-051 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-051 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-051 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-051 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-053 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-053 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-053 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-053 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-053 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-053 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-053 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-053 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-053 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-053 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
| 50242-053 | Rituxan | rituximab | Genentech, Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69713 | SUPPL | 2021-12-21 |
| 69634 | SUPPL | 2021-12-19 |
| 69478 | SUPPL | 2021-12-06 |
| 69456 | SUPPL | 2021-12-03 |
| 69455 | SUPPL | 2021-12-03 |
| 68004 | SUPPL | 2021-07-01 |
| 67998 | SUPPL | 2021-07-01 |
| 67997 | SUPPL | 2021-07-01 |
| 64505 | SUPPL | 2020-09-04 |
| 64458 | SUPPL | 2020-09-01 |
| 62156 | SUPPL | 2020-03-17 |
| 62155 | SUPPL | 2020-03-17 |
| 61640 | SUPPL | 2020-01-24 |
| 61632 | SUPPL | 2020-01-24 |
| 61510 | SUPPL | 2020-01-10 |
| 61119 | SUPPL | 2019-12-03 |
| 60180 | SUPPL | 2019-10-01 |
| 60179 | SUPPL | 2019-10-01 |
| 60167 | SUPPL | 2019-10-01 |
| 57532 | SUPPL | 2019-02-13 |
| 57357 | SUPPL | 2019-01-28 |
| 56076 | SUPPL | 2018-10-23 |
| 56042 | SUPPL | 2018-10-19 |
| 54562 | SUPPL | 2018-06-14 |
| 54536 | SUPPL | 2018-06-12 |
| 53615 | SUPPL | 2018-04-05 |
| 53607 | SUPPL | 2018-04-04 |
| 31623 | SUPPL | 2014-08-14 |
| 39680 | SUPPL | 2014-08-13 |
| 43276 | SUPPL | 2014-08-01 |
| 18619 | SUPPL | 2013-09-27 |
| 9424 | SUPPL | 2013-09-26 |
| 18618 | SUPPL | 2013-05-14 |
| 9423 | SUPPL | 2013-05-13 |
| 9422 | SUPPL | 2012-10-22 |
| 9420 | SUPPL | 2012-10-22 |
| 39679 | SUPPL | 2012-10-19 |
| 39677 | SUPPL | 2012-10-19 |
| 39678 | SUPPL | 2012-07-30 |
| 9421 | SUPPL | 2012-07-17 |
| 18617 | SUPPL | 2012-04-24 |
| 31622 | SUPPL | 2012-04-19 |
| 31621 | SUPPL | 2012-02-23 |
| 39676 | SUPPL | 2012-02-22 |
| 9419 | SUPPL | 2011-04-22 |
| 18616 | SUPPL | 2011-04-21 |
| 9418 | SUPPL | 2011-02-04 |
| 18614 | SUPPL | 2011-01-31 |
| 31620 | SUPPL | 2011-01-14 |
| 18615 | SUPPL | 2011-01-10 |
| 31619 | SUPPL | 2010-02-25 |
| 31618 | SUPPL | 2010-02-25 |
| 18613 | SUPPL | 2010-02-19 |
| 18612 | SUPPL | 2010-02-19 |
| 31617 | SUPPL | 2009-10-26 |
| 18611 | SUPPL | 2009-10-22 |
| 31616 | SUPPL | 2008-09-16 |
| 9417 | SUPPL | 2008-09-16 |
| 39675 | SUPPL | 2008-01-31 |
| 39674 | SUPPL | 2008-01-30 |
| 9414 | SUPPL | 2008-01-30 |
| 18610 | SUPPL | 2007-10-10 |
| 9416 | SUPPL | 2007-10-04 |
| 18609 | SUPPL | 2007-08-30 |
| 9415 | SUPPL | 2007-08-30 |
| 18608 | SUPPL | 2007-03-07 |
| 31615 | SUPPL | 2007-03-06 |
| 9413 | SUPPL | 2006-10-05 |
| 39673 | SUPPL | 2006-10-02 |
| 18607 | SUPPL | 2006-10-02 |
| 18606 | SUPPL | 2006-03-14 |
| 9412 | SUPPL | 2006-03-14 |
| 18605 | SUPPL | 2006-02-14 |
| 43275 | ORIG | 2004-09-22 |
| 39672 | ORIG | 2004-09-22 |
| 31614 | ORIG | 2004-09-22 |
| 23942 | ORIG | 2004-09-22 |