Application 021773
- Type
- NDA
- Sponsor
- ASTRAZENECA AB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BYETTA | EXENATIDE SYNTHETIC | INJECTABLE;SUBCUTANEOUS | 300MCG/1.2ML (250MCG/ML) | Yes | Yes |
| 002 | BYETTA | EXENATIDE SYNTHETIC | INJECTABLE;SUBCUTANEOUS | 600MCG/2.4ML (250MCG/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0310-6512 | Byetta | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6512 | Byetta | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6512 | Byetta | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6512 | Byetta | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6512 | Byetta | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6512 | Byetta | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6512 | Byetta | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6524 | Byetta | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6524 | Byetta | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6524 | Byetta | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6524 | Byetta | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6524 | Byetta | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6524 | Byetta | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6524 | Byetta | exenatide | AstraZeneca Pharmaceuticals LP | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83277 | SUPPL | 2025-09-03 |
| 83276 | SUPPL | 2025-09-03 |
| 82382 | SUPPL | 2025-06-02 |
| 82381 | SUPPL | 2025-06-02 |
| 82342 | SUPPL | 2025-05-29 |
| 80118 | SUPPL | 2024-11-05 |
| 80109 | SUPPL | 2024-11-04 |
| 73016 | SUPPL | 2022-12-23 |
| 73015 | SUPPL | 2022-12-23 |
| 72992 | SUPPL | 2022-12-22 |
| 71295 | SUPPL | 2022-06-14 |
| 71294 | SUPPL | 2022-06-14 |
| 71283 | SUPPL | 2022-06-13 |
| 71282 | SUPPL | 2022-06-13 |
| 69264 | SUPPL | 2021-11-05 |
| 69259 | SUPPL | 2021-11-05 |
| 69258 | SUPPL | 2021-11-05 |
| 67857 | SUPPL | 2021-06-22 |
| 67856 | SUPPL | 2021-06-22 |
| 67850 | SUPPL | 2021-06-22 |
| 62012 | SUPPL | 2020-03-03 |
| 62002 | SUPPL | 2020-03-02 |
| 62001 | SUPPL | 2020-03-02 |
| 56971 | SUPPL | 2018-12-21 |
| 56970 | SUPPL | 2018-12-21 |
| 37617 | SUPPL | 2015-03-03 |
| 28570 | SUPPL | 2015-02-27 |
| 16346 | SUPPL | 2014-11-26 |
| 6152 | SUPPL | 2014-11-26 |
| 16345 | SUPPL | 2011-11-04 |
| 16344 | SUPPL | 2011-11-04 |
| 28569 | SUPPL | 2011-10-24 |
| 6150 | SUPPL | 2011-10-24 |
| 6151 | SUPPL | 2011-08-10 |
| 28568 | SUPPL | 2010-11-18 |
| 37616 | SUPPL | 2010-11-17 |
| 28567 | SUPPL | 2010-08-20 |
| 43778 | ORIG | 2009-11-18 |
| 28566 | SUPPL | 2009-11-18 |
| 28565 | SUPPL | 2009-11-18 |
| 28564 | SUPPL | 2009-11-18 |
| 6149 | SUPPL | 2009-11-18 |
| 6148 | SUPPL | 2009-11-18 |
| 6147 | SUPPL | 2009-11-18 |
| 37615 | SUPPL | 2009-11-04 |
| 37613 | SUPPL | 2009-11-04 |
| 16343 | SUPPL | 2009-11-04 |
| 16342 | SUPPL | 2009-11-04 |
| 16341 | SUPPL | 2009-11-04 |
| 16339 | SUPPL | 2009-11-04 |
| 44151 | ORIG | 2009-11-02 |
| 28562 | SUPPL | 2008-06-20 |
| 16340 | SUPPL | 2008-06-19 |
| 28563 | SUPPL | 2008-01-18 |
| 37614 | SUPPL | 2008-01-15 |
| 6146 | SUPPL | 2007-02-23 |
| 37612 | SUPPL | 2007-02-16 |
| 28561 | SUPPL | 2007-01-08 |
| 6145 | SUPPL | 2007-01-08 |
| 37611 | SUPPL | 2006-12-28 |
| 16336 | SUPPL | 2006-12-28 |
| 28560 | SUPPL | 2006-11-06 |
| 16338 | SUPPL | 2006-11-06 |
| 28559 | SUPPL | 2006-10-18 |
| 16337 | SUPPL | 2006-10-13 |
| 42305 | ORIG | 2005-08-04 |
| 37610 | ORIG | 2005-05-03 |
| 28558 | ORIG | 2005-05-03 |