Application 022465
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VOTRIENT | PAZOPANIB HYDROCHLORIDE | TABLET;ORAL | EQ 200MG BASE | Yes | Yes |
| 002 | VOTRIENT | PAZOPANIB HYDROCHLORIDE | TABLET;ORAL | EQ 400MG BASE | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0670 | VOTRIENT | pazopanib hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0670 | VOTRIENT | pazopanib hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0670 | VOTRIENT | pazopanib hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0670 | VOTRIENT | pazopanib hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0670 | VOTRIENT | pazopanib hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0670 | VOTRIENT | pazopanib hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0670 | VOTRIENT | pazopanib hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0670 | VOTRIENT | pazopanib hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1077 | VOTRIENT | pazopanib hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1077 | VOTRIENT | pazopanib hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1077 | VOTRIENT | pazopanib hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77316 | SUPPL | 2024-01-26 |
| 77313 | SUPPL | 2024-01-26 |
| 77312 | SUPPL | 2024-01-26 |
| 70233 | SUPPL | 2022-02-23 |
| 70185 | SUPPL | 2022-02-18 |
| 68816 | SUPPL | 2021-09-30 |
| 68815 | SUPPL | 2021-09-30 |
| 68814 | SUPPL | 2021-09-30 |
| 68733 | SUPPL | 2021-09-23 |
| 68732 | SUPPL | 2021-09-23 |
| 64294 | SUPPL | 2020-08-18 |
| 64293 | SUPPL | 2020-08-18 |
| 64292 | SUPPL | 2020-08-18 |
| 64058 | SUPPL | 2020-07-23 |
| 64057 | SUPPL | 2020-07-23 |
| 63974 | SUPPL | 2020-07-20 |
| 63467 | SUPPL | 2020-06-09 |
| 63466 | SUPPL | 2020-06-09 |
| 63408 | SUPPL | 2020-06-03 |
| 48646 | SUPPL | 2017-06-05 |
| 48645 | SUPPL | 2017-06-05 |
| 48623 | SUPPL | 2017-06-01 |
| 48622 | SUPPL | 2017-06-01 |
| 48621 | SUPPL | 2017-06-01 |
| 48620 | SUPPL | 2017-06-01 |
| 45038 | SUPPL | 2016-08-05 |
| 45002 | SUPPL | 2016-08-05 |
| 29757 | SUPPL | 2016-05-24 |
| 17615 | SUPPL | 2016-05-23 |
| 17614 | SUPPL | 2015-10-06 |
| 29756 | SUPPL | 2015-09-24 |
| 38741 | SUPPL | 2015-04-02 |
| 7431 | SUPPL | 2015-04-02 |
| 17613 | SUPPL | 2015-04-01 |
| 17612 | SUPPL | 2014-11-20 |
| 7430 | SUPPL | 2014-11-20 |
| 29755 | SUPPL | 2014-06-05 |
| 38740 | SUPPL | 2014-06-04 |
| 7429 | SUPPL | 2013-12-18 |
| 38739 | SUPPL | 2013-12-03 |
| 29754 | SUPPL | 2013-08-16 |
| 29753 | SUPPL | 2013-08-16 |
| 7428 | SUPPL | 2013-08-16 |
| 38738 | SUPPL | 2013-08-15 |
| 17611 | SUPPL | 2013-08-15 |
| 17610 | SUPPL | 2013-08-15 |
| 38737 | SUPPL | 2012-11-16 |
| 7427 | SUPPL | 2012-11-16 |
| 29752 | SUPPL | 2012-05-02 |
| 7425 | SUPPL | 2012-05-02 |
| 17609 | SUPPL | 2012-04-27 |
| 17607 | SUPPL | 2012-04-27 |
| 7426 | SUPPL | 2012-03-26 |
| 17608 | SUPPL | 2012-03-23 |
| 38736 | SUPPL | 2012-01-23 |
| 7424 | SUPPL | 2012-01-17 |
| 38735 | SUPPL | 2011-10-25 |
| 17606 | SUPPL | 2011-10-25 |
| 7422 | SUPPL | 2011-10-25 |
| 7421 | SUPPL | 2011-10-25 |
| 7423 | SUPPL | 2011-04-22 |
| 38734 | SUPPL | 2010-05-07 |
| 7420 | SUPPL | 2010-05-03 |
| 24315 | ORIG | 2010-01-22 |
| 22028 | ORIG | 2010-01-22 |
| 7419 | ORIG | 2009-11-03 |
| 17605 | ORIG | 2009-10-20 |