Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 218623
Company: AQUESTIVE
Company: AQUESTIVE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIBERVANT | DIAZEPAM | 5MG | FILM;BUCCAL | None (Tentative Approval) | None | Yes | No |
| LIBERVANT | DIAZEPAM | 7.5MG | FILM;BUCCAL | None (Tentative Approval) | None | Yes | No |
| LIBERVANT | DIAZEPAM | 10MG | FILM;BUCCAL | None (Tentative Approval) | None | Yes | No |
| LIBERVANT | DIAZEPAM | 12.5MG | FILM;BUCCAL | None (Tentative Approval) | None | Yes | No |
| LIBERVANT | DIAZEPAM | 15MG | FILM;BUCCAL | None (Tentative Approval) | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/02/2025 | ORIG-1 | Tentative Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218623Orig1s000ltr.pdf |