Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 218654
Company: HETERO LABS LIMITED
Company: HETERO LABS LIMITED
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SOLRIAMFETOL | SOLRIAMFETOL | 300MG | TABLET | None (Tentative Approval) | None | No | No |
| SOLRIAMFETOL | SOLRIAMFETOL | 75MG | TABLET | None (Tentative Approval) | None | No | No |
| SOLRIAMFETOL | SOLRIAMFETOL | 150MG | TABLET | None (Tentative Approval) | 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 |
|---|---|---|---|---|---|---|---|
| 12/11/2024 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218654Orig1s000TAltr.pdf |