Application 206538
- Type
- BLA
- Sponsor
- SANOFI US SERVICES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TOUJEO SOLOSTAR | INSULIN GLARGINE RECOMBINANT | SOLUTION;SUBCUTANEOUS | 450 UNITS/1.5ML (300 UNITS/ML) | No | No |
| 002 | TOUJEO MAX SOLOSTAR | INSULIN GLARGINE RECOMBINANT | SOLUTION;SUBCUTANEOUS | 900 UNITS/3ML (300 UNITS/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0024-5869 | TOUJEO | insulin glargine | Sanofi-Aventis U.S. LLC | BLA | Current |
| 0024-5869 | TOUJEO | insulin glargine | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5869 | TOUJEO | insulin glargine | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5869 | TOUJEO | insulin glargine | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5869 | TOUJEO | insulin glargine | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5869 | TOUJEO | insulin glargine | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5869 | TOUJEO | insulin glargine | Sanofi-Aventis U.S. LLC | BLA | Current |
| 0024-5869 | TOUJEO | insulin glargine | Sanofi-Aventis U.S. LLC | BLA | Current |
| 0024-5869 | TOUJEO | insulin glargine | Sanofi-Aventis U.S. LLC | BLA | Current |
| 0024-5871 | TOUJEO Max | insulin glargine | Sanofi-Aventis U.S. LLC | BLA | Current |
| 0024-5871 | TOUJEO Max | insulin glargine | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5871 | TOUJEO Max | insulin glargine | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5871 | TOUJEO Max | insulin glargine | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5871 | TOUJEO Max | insulin glargine | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5871 | TOUJEO Max | insulin glargine | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5871 | TOUJEO Max | insulin glargine | Sanofi-Aventis U.S. LLC | BLA | Current |
| 0024-5871 | TOUJEO Max | insulin glargine | Sanofi-Aventis U.S. LLC | BLA | Current |
| 0024-5871 | TOUJEO Max | insulin glargine | Sanofi-Aventis U.S. LLC | BLA | Current |
| 50090-2193 | TOUJEO | insulin glargine | A-S Medication Solutions | BLA | Current |
| 50090-2193 | TOUJEO | insulin glargine | A-S Medication Solutions | NDA | Current |
| 50090-4177 | TOUJEO Max | insulin glargine | A-S Medication Solutions | BLA | Current |
| 50090-4177 | TOUJEO Max | insulin glargine | A-S Medication Solutions | BLA | Current |
| 50090-4177 | TOUJEO Max | insulin glargine | A-S Medication Solutions | NDA | Current |