Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761325
Company: SANOFI-AVENTIS U.S. LLC
Company: SANOFI-AVENTIS U.S. LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MERILOG | INSULIN ASPART-SZJJ | 10ML(100UNITS/ML) | INJECTION;SOLUTION | Prescription | None | No | No |
| MERILOG SOLOSTAR | INSULIN ASPART-SZJJ | 3ML(100UNITS/ML) | INJECTION;SOLUTION | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/14/2025 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761325Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761325Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/14/2025 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761325Orig1s000lbl.pdf |