Application 022417
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORVIR | RITONAVIR | TABLET;ORAL | 100MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0074-2340 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-2340 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-3333 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-3333 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-3333 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-3333 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-3333 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-3333 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-3333 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-3333 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-3333 | Norvir | Ritonavir | AbbVie Inc. | NDA | Current |
| 50090-1162 | Norvir | Ritonavir | A-S Medication Solutions | NDA | Current |
| 53808-1119 | Norvir | Ritonavir | DOH CENTRAL PHARMACY | NDA | Current |
| 67296-1234 | Norvir | Norvir | RedPharm Drug, Inc. | NDA | Current |
| 67296-1234 | Norvir | Norvir | RedPharm Drug, Inc. | NDA | Current |
| 68382-696 | Ritonavir | Ritonavir | Zydus Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
| 68382-696 | Ritonavir | Ritonavir | Zydus Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72958 | SUPPL | 2022-12-20 |
| 72916 | SUPPL | 2022-12-16 |
| 65023 | SUPPL | 2020-10-23 |
| 64974 | SUPPL | 2020-10-22 |
| 61485 | SUPPL | 2019-12-31 |
| 61380 | SUPPL | 2019-12-23 |
| 59815 | SUPPL | 2019-08-22 |
| 59806 | SUPPL | 2019-08-22 |
| 56682 | SUPPL | 2018-12-07 |
| 56540 | SUPPL | 2018-11-23 |
| 49925 | SUPPL | 2017-10-03 |
| 49918 | SUPPL | 2017-10-03 |
| 48885 | SUPPL | 2017-06-30 |
| 48877 | SUPPL | 2017-06-30 |
| 48679 | SUPPL | 2017-06-08 |
| 48678 | SUPPL | 2017-06-08 |
| 46531 | SUPPL | 2016-12-23 |
| 46512 | SUPPL | 2016-12-22 |
| 45993 | SUPPL | 2016-12-01 |
| 45949 | SUPPL | 2016-11-23 |
| 45285 | SUPPL | 2016-09-19 |
| 45310 | SUPPL | 2016-09-15 |
| 29704 | SUPPL | 2015-11-17 |
| 17564 | SUPPL | 2015-11-12 |
| 17563 | SUPPL | 2015-04-07 |
| 7357 | SUPPL | 2015-04-03 |
| 38680 | SUPPL | 2015-03-19 |
| 7356 | SUPPL | 2015-03-17 |
| 17562 | SUPPL | 2013-11-08 |
| 7355 | SUPPL | 2013-11-08 |
| 38679 | SUPPL | 2012-11-28 |
| 7354 | SUPPL | 2012-11-23 |
| 7353 | SUPPL | 2012-02-27 |
| 38678 | SUPPL | 2012-02-22 |
| 17561 | SUPPL | 2011-12-14 |
| 7352 | SUPPL | 2011-12-08 |
| 42517 | ORIG | 2010-06-06 |
| 24302 | ORIG | 2010-06-06 |
| 17560 | SUPPL | 2010-05-07 |
| 29703 | SUPPL | 2010-05-03 |
| 7351 | ORIG | 2010-02-17 |
| 38677 | ORIG | 2010-02-16 |