Application 020659
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORVIR | RITONAVIR | SOLUTION;ORAL | 80MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0074-1940 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-1940 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-1940 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-1940 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-1940 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-1940 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-1940 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-1940 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-1940 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72959 | SUPPL | 2022-12-20 |
| 72917 | SUPPL | 2022-12-16 |
| 65022 | SUPPL | 2020-10-23 |
| 64973 | SUPPL | 2020-10-22 |
| 61483 | SUPPL | 2019-12-31 |
| 61378 | SUPPL | 2019-12-23 |
| 59814 | SUPPL | 2019-08-22 |
| 59804 | SUPPL | 2019-08-22 |
| 56681 | SUPPL | 2018-12-07 |
| 56545 | SUPPL | 2018-11-23 |
| 49924 | SUPPL | 2017-10-03 |
| 49917 | SUPPL | 2017-10-03 |
| 48884 | SUPPL | 2017-06-30 |
| 48876 | SUPPL | 2017-06-30 |
| 48677 | SUPPL | 2017-06-08 |
| 48676 | SUPPL | 2017-06-08 |
| 46530 | SUPPL | 2016-12-23 |
| 46511 | SUPPL | 2016-12-22 |
| 45989 | SUPPL | 2016-12-01 |
| 45948 | SUPPL | 2016-11-23 |
| 45288 | SUPPL | 2016-09-19 |
| 45311 | SUPPL | 2016-09-15 |
| 25465 | SUPPL | 2015-11-17 |
| 35102 | SUPPL | 2015-11-12 |
| 35101 | SUPPL | 2015-04-07 |
| 3028 | SUPPL | 2015-04-03 |
| 12945 | SUPPL | 2015-03-19 |
| 3027 | SUPPL | 2015-03-17 |
| 25464 | SUPPL | 2013-11-08 |
| 12944 | SUPPL | 2013-11-08 |
| 35100 | SUPPL | 2012-11-28 |
| 3026 | SUPPL | 2012-11-23 |
| 3025 | SUPPL | 2012-02-27 |
| 35099 | SUPPL | 2012-02-22 |
| 12943 | SUPPL | 2011-12-14 |
| 3024 | SUPPL | 2011-12-08 |
| 12942 | SUPPL | 2010-05-07 |
| 25463 | SUPPL | 2010-05-03 |
| 25461 | SUPPL | 2010-02-17 |
| 12941 | SUPPL | 2010-02-16 |
| 25462 | SUPPL | 2010-01-20 |
| 35098 | SUPPL | 2009-12-02 |
| 35097 | SUPPL | 2009-08-04 |
| 25460 | SUPPL | 2008-10-02 |
| 25459 | SUPPL | 2008-09-03 |
| 12940 | SUPPL | 2008-08-29 |
| 3023 | SUPPL | 2008-05-20 |
| 41530 | SUPPL | 2007-11-19 |
| 41529 | SUPPL | 2007-11-19 |
| 35096 | SUPPL | 2007-08-02 |
| 25458 | SUPPL | 2007-08-02 |
| 35095 | SUPPL | 2007-05-16 |
| 3022 | SUPPL | 2007-05-16 |
| 3021 | SUPPL | 2005-11-18 |
| 35094 | SUPPL | 2005-11-17 |
| 25457 | SUPPL | 2005-10-11 |
| 12939 | SUPPL | 2005-10-10 |
| 41528 | SUPPL | 2005-04-27 |
| 35093 | SUPPL | 2005-03-30 |
| 3020 | SUPPL | 2005-03-30 |
| 12938 | SUPPL | 2003-09-25 |
| 3019 | SUPPL | 2003-09-25 |
| 12937 | SUPPL | 2003-04-25 |
| 35092 | SUPPL | 2002-03-14 |
| 3018 | SUPPL | 2002-03-14 |
| 3017 | SUPPL | 2001-03-06 |
| 57468 | ORIG | 1997-04-09 |
| 52169 | SUPPL | 1900-01-01 |
| 52168 | SUPPL | 1900-01-01 |
| 52167 | SUPPL | 1900-01-01 |
| 52166 | SUPPL | 1900-01-01 |