Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 212641
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 | No | No |
LIBERVANT | DIAZEPAM | 7.5MG | FILM;BUCCAL | None (Tentative Approval) | None | No | No |
LIBERVANT | DIAZEPAM | 10MG | FILM;BUCCAL | None (Tentative Approval) | None | No | No |
LIBERVANT | DIAZEPAM | 12.5MG | FILM;BUCCAL | None (Tentative Approval) | None | No | No |
LIBERVANT | DIAZEPAM | 15MG | FILM;BUCCAL | None (Tentative Approval) | None | No | No |
LIBERVANT | DIAZEPAM | 17.5MG | FILM;BUCCAL | None (Tentative Approval) | None | No | No |
LIBERVANT | DIAZEPAM | 20MG | FILM;BUCCAL | 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 |
---|---|---|---|---|---|---|---|
08/30/2022 | ORIG-1 | Tentative Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Letter (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212641Orig1s000TAltr.pdf |