Application 209210
- Type
- NDA
- Sponsor
- ASTRAZENECA AB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BYDUREON BCISE | EXENATIDE | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0310-6540 | BYDUREON BCise | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6540 | BYDUREON BCise | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6540 | BYDUREON BCise | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6540 | BYDUREON BCise | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6540 | BYDUREON BCise | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6540 | BYDUREON BCise | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6540 | BYDUREON BCise | exenatide | AstraZeneca Pharmaceutica | NDA | Current |
| 0310-6540 | BYDUREON BCise | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6540 | BYDUREON BCise | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6540 | BYDUREON BCise | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6540 | BYDUREON BCise | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6540 | BYDUREON BCise | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82387 | SUPPL | 2025-06-02 |
| 82386 | SUPPL | 2025-06-02 |
| 82349 | SUPPL | 2025-05-29 |
| 80126 | SUPPL | 2024-11-05 |
| 80108 | SUPPL | 2024-11-04 |
| 80107 | SUPPL | 2024-11-04 |
| 77781 | SUPPL | 2024-03-12 |
| 77748 | SUPPL | 2024-03-07 |
| 73012 | SUPPL | 2022-12-23 |
| 73011 | SUPPL | 2022-12-23 |
| 72998 | SUPPL | 2022-12-22 |
| 71646 | SUPPL | 2022-07-27 |
| 71645 | SUPPL | 2022-07-27 |
| 71640 | SUPPL | 2022-07-27 |
| 71321 | SUPPL | 2022-06-15 |
| 71320 | SUPPL | 2022-06-15 |
| 71303 | SUPPL | 2022-06-14 |
| 68179 | SUPPL | 2021-07-26 |
| 68165 | SUPPL | 2021-07-23 |
| 65493 | SUPPL | 2020-12-03 |
| 65476 | SUPPL | 2020-12-02 |
| 65475 | SUPPL | 2020-12-02 |
| 62016 | SUPPL | 2020-03-03 |
| 62007 | SUPPL | 2020-03-02 |
| 62006 | SUPPL | 2020-03-02 |
| 59513 | SUPPL | 2019-07-30 |
| 59512 | SUPPL | 2019-07-30 |
| 59511 | SUPPL | 2019-07-30 |
| 59510 | SUPPL | 2019-07-30 |
| 59509 | SUPPL | 2019-07-30 |
| 59508 | SUPPL | 2019-07-30 |
| 59507 | SUPPL | 2019-07-30 |
| 59505 | SUPPL | 2019-07-30 |
| 59461 | SUPPL | 2019-07-26 |
| 59460 | SUPPL | 2019-07-26 |
| 59459 | SUPPL | 2019-07-26 |
| 59458 | SUPPL | 2019-07-26 |
| 59457 | SUPPL | 2019-07-26 |
| 59456 | SUPPL | 2019-07-26 |
| 59455 | SUPPL | 2019-07-26 |
| 57724 | SUPPL | 2019-02-21 |
| 57708 | SUPPL | 2019-02-20 |
| 55864 | ORIG | 2018-10-10 |
| 50488 | ORIG | 2017-11-27 |
| 50156 | ORIG | 2017-10-24 |