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 | Prescription | None | Yes | No |
LIBERVANT | DIAZEPAM | 7.5MG | FILM;BUCCAL | Prescription | None | Yes | No |
LIBERVANT | DIAZEPAM | 10MG | FILM;BUCCAL | Prescription | None | Yes | No |
LIBERVANT | DIAZEPAM | 12.5MG | FILM;BUCCAL | Prescription | None | Yes | No |
LIBERVANT | DIAZEPAM | 15MG | FILM;BUCCAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
04/26/2024 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218623s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218623Orig1s000ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/26/2024 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218623s000lbl.pdf |