Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
DIAZEPAM | N218623 | AQUESTIVE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, P.C. (on behalf of Aquestive ... FDA-2024-P-3563 · 3 docket documents Hyman, Phelps & McNamara, P.C., on behalf of Aquestive Therapeutics, Inc., submitted this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA refuse to approve any nasal spray drug product lacking food-effect studies if the active moiety has demonstr | 505(q) | 2024-07-30 | Partially Denied | Aquestive Therapeutics, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.