DIAZEPAM | N020648 | BAUSCH HEALTH US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition and Petition for Stay of Action from Arent Fox LLP on behalf... FDA-2019-P-5121 · 9 docket documents Arent Fox LLP, on behalf of Aquestive Therapeutics, Inc., filed a 505(q) citizen petition requesting that the FDA stay approval of Neurelis's 505(b)(2) NDA for Valtoco (diazepam intranasal solution) and require additional clinical studies, including a bridging study comparing Valtoco to Diastat (dia | 505(q) Stay Request | 2019-11-04 | Denied | — |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2006-P-0386 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on May 15, 2006, requesting that the FDA Commissioner determine whether Diastat (diazepam rectal gel) in strengths of 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, originally approved under NDA 20-648 and held by Valeant Pharmaceuticals, were | 505(q) | 2009-04-09 | Granted | Lachman Consultant Services, Inc. |
Citizen Petition from Valeant Pharmaceuticals International (Valeant) FDA-2006-P-0009 · 6 docket documents Valeant Pharmaceuticals International filed this petition on September 22, 2006, pursuant to section 505 of the Food, Drug, and Cosmetic Act, requesting that the FDA refrain from approving any abbreviated new drug application (ANDA) for diazepam rectal gel products referencing the withdrawn fixed-do | 505(q) | 2008-08-13 | Denied | Valeant Pharmaceuticals International (Valeant) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.