Application 208471
- Type
- BLA
- Sponsor
- SANOFI-AVENTIS US
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 208471 | Adlyxin | lixisenatide | 351(a) | Disc | 2026-07-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ADLYXIN | LIXISENATIDE | SOLUTION;SUBCUTANEOUS | 0.15MG/3ML (0.05MG/ML) | No | No |
| 002 | ADLYXIN | LIXISENATIDE | SOLUTION;SUBCUTANEOUS | 0.3MG/3ML (0.1MG/ML) | No | No |
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 8 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0024-5745 | ADLYXIN | Lixisenatide | sanofi-aventis U.S. LLC | BLA | Current |
| 0024-5745 | ADLYXIN | Lixisenatide | Sanofi-Aventis U.S. LLC | BLA | Current |
| 0024-5745 | ADLYXIN | Lixisenatide | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5745 | ADLYXIN | Lixisenatide | sanofi-aventis U.S. LLC | BLA | Current |
| 0024-5747 | ADLYXIN | Lixisenatide | sanofi-aventis U.S. LLC | BLA | Current |
| 0024-5747 | ADLYXIN | Lixisenatide | Sanofi-Aventis U.S. LLC | BLA | Current |
| 0024-5747 | ADLYXIN | Lixisenatide | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5747 | ADLYXIN | Lixisenatide | sanofi-aventis U.S. LLC | BLA | Current |