Application 022405
- Type
- NDA
- Sponsor
- GENZYME CORP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CAPRELSA | VANDETANIB | TABLET;ORAL | 100MG | Yes | No |
| 002 | CAPRELSA | VANDETANIB | TABLET;ORAL | 300MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0310-7820 | CAPRELSA | Vandetanib | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-7840 | CAPRELSA | Vandetanib | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 58468-7820 | CAPRELSA | Vandetanib | Genzyme Corporation | NDA | Current |
| 58468-7820 | CAPRELSA | Vandetanib | Genzyme Corporation | NDA | Current |
| 58468-7820 | CAPRELSA | Vandetanib | Genzyme Corporation | NDA | Current |
| 58468-7820 | CAPRELSA | Vandetanib | Genzyme Corporation | NDA | Current |
| 58468-7820 | CAPRELSA | Vandetanib | Genzyme Corporation | NDA | Current |
| 58468-7820 | CAPRELSA | Vandetanib | Genzyme Corporation | NDA | Current |
| 58468-7840 | CAPRELSA | Vandetanib | Genzyme Corporation | NDA | Current |
| 58468-7840 | CAPRELSA | Vandetanib | Genzyme Corporation | NDA | Current |
| 58468-7840 | CAPRELSA | Vandetanib | Genzyme Corporation | NDA | Current |
| 58468-7840 | CAPRELSA | Vandetanib | Genzyme Corporation | NDA | Current |
| 58468-7840 | CAPRELSA | Vandetanib | Genzyme Corporation | NDA | Current |
| 58468-7840 | CAPRELSA | Vandetanib | Genzyme Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84866 | SUPPL | 2026-01-28 |
| 84848 | SUPPL | 2026-01-28 |
| 83446 | SUPPL | 2025-09-25 |
| 82676 | SUPPL | 2025-06-27 |
| 82300 | SUPPL | 2025-05-23 |
| 82245 | SUPPL | 2025-05-14 |
| 82244 | SUPPL | 2025-05-14 |
| 77768 | SUPPL | 2024-03-08 |
| 77767 | SUPPL | 2024-03-08 |
| 77758 | SUPPL | 2024-03-08 |
| 73988 | SUPPL | 2023-04-14 |
| 70657 | SUPPL | 2022-03-30 |
| 70656 | SUPPL | 2022-03-30 |
| 70637 | SUPPL | 2022-03-29 |
| 63650 | SUPPL | 2020-06-22 |
| 63617 | SUPPL | 2020-06-18 |
| 63579 | SUPPL | 2020-06-15 |
| 63442 | SUPPL | 2020-06-08 |
| 63440 | SUPPL | 2020-06-08 |
| 63439 | SUPPL | 2020-06-05 |
| 56238 | SUPPL | 2018-11-01 |
| 55967 | SUPPL | 2018-10-17 |
| 55913 | SUPPL | 2018-10-15 |
| 48460 | SUPPL | 2017-05-19 |
| 38665 | SUPPL | 2016-08-02 |
| 29692 | SUPPL | 2016-08-01 |
| 29691 | SUPPL | 2014-04-02 |
| 17327 | SUPPL | 2014-04-01 |
| 7333 | SUPPL | 2013-12-05 |
| 29690 | SUPPL | 2013-07-08 |
| 17326 | SUPPL | 2013-07-05 |
| 38664 | SUPPL | 2012-10-12 |
| 7332 | SUPPL | 2012-10-11 |
| 24029 | ORIG | 2011-07-08 |
| 38663 | SUPPL | 2011-06-29 |
| 29689 | SUPPL | 2011-06-29 |
| 44748 | ORIG | 2011-05-03 |
| 42509 | ORIG | 2011-05-03 |
| 17325 | ORIG | 2011-04-15 |
| 29688 | ORIG | 2011-04-11 |
| 23393 | ORIG | 2011-04-07 |