Application 208673
- Type
- BLA
- Sponsor
- SANOFI-AVENTIS US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SOLIQUA 100/33 | INSULIN GLARGINE; LIXISENATIDE | SOLUTION;SUBCUTANEOUS | 300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0024-5761 | Soliqua 100/33 | insulin glargine and lixisenatide | Sanofi-Aventis U.S. LLC | BLA | Current |
| 0024-5761 | Soliqua 100/33 | insulin glargine and lixisenatide | Sanofi-Aventis U.S. LLC | BLA | Current |
| 0024-5761 | Soliqua 100/33 | insulin glargine and lixisenatide | sanofi-aventis U.S. LLC | BLA | Current |
| 0024-5761 | Soliqua 100/33 | insulin glargine and lixisenatide | sanofi-aventis U.S. LLC | BLA | Current |
| 0024-5761 | Soliqua 100/33 | insulin glargine and lixisenatide | Sanofi-Aventis U.S. LLC | BLA | Current |
| 0024-5761 | Soliqua 100/33 | insulin glargine and lixisenatide | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5761 | Soliqua 100/33 | insulin glargine and lixisenatide | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5761 | Soliqua 100/33 | insulin glargine and lixisenatide | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5761 | Soliqua 100/33 | insulin glargine and lixisenatide | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5761 | Soliqua 100/33 | insulin glargine and lixisenatide | Sanofi-Aventis U.S. LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85389 | SUPPL | 2026-03-18 |
| 85375 | SUPPL | 2026-03-16 |
| 85390 | SUPPL | 2026-03-12 |
| 82388 | SUPPL | 2025-06-02 |
| 82348 | SUPPL | 2025-05-29 |
| 80125 | SUPPL | 2024-11-05 |
| 80101 | SUPPL | 2024-11-04 |
| 75622 | SUPPL | 2023-09-29 |
| 75610 | SUPPL | 2023-09-28 |
| 71330 | SUPPL | 2022-06-15 |
| 71329 | SUPPL | 2022-06-15 |
| 71272 | SUPPL | 2022-06-13 |
| 68226 | SUPPL | 2021-07-29 |
| 68225 | SUPPL | 2021-07-29 |
| 68219 | SUPPL | 2021-07-29 |
| 62439 | APPL | 2020-04-05 |
| 60941 | SUPPL | 2020-03-23 |
| 60940 | SUPPL | 2020-03-23 |
| 60939 | SUPPL | 2020-03-23 |
| 60938 | SUPPL | 2020-03-23 |
| 60885 | SUPPL | 2020-03-23 |
| 60884 | SUPPL | 2020-03-23 |
| 57854 | SUPPL | 2020-03-23 |
| 57853 | SUPPL | 2020-03-23 |
| 57835 | SUPPL | 2020-03-23 |
| 49644 | SUPPL | 2020-03-23 |
| 49618 | SUPPL | 2020-03-23 |
| 49617 | SUPPL | 2020-03-23 |
| 46603 | ORIG | 2020-03-23 |
| 46601 | ORIG | 2020-03-23 |
| 45932 | ORIG | 2020-03-23 |
| 45929 | ORIG | 2020-03-23 |