VALIUM

FDA-1985-P-0507 · 4 docket documents

Roxane Laboratories, Inc. filed this petition on December 5, 1985, requesting that the FDA determine whether Diazepam Intensol (Concentrated Oral Solution) 5 mg per ml is suitable for an ANDA application, positioning it as similar to the listed drug Valium Tablets 5 mg and arguing that the concentra

FDA-2023-P-4300 · 11 docket documents

Lachman Consultant Services, Inc. filed this suitability petition on behalf of a client requesting that the FDA declare Diazepam Injection USP, 20 mg/4 mL (5 mg/mL) single dose prefilled syringe suitable for submission as an ANDA under Section 505(j)(2)(C) of the FD&C Act, with the proposed product

FDA-2022-P-0118 · 6 docket documents

Lachman Consulting Services Inc. filed a petition under section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Diazepam Injection USP, 20 mg/4 mL (5 mg/mL) single dose prefilled syringe suitable for submission as an abbreviated new drug application (ANDA), w

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

FDA-2010-P-0091 · 6 docket documents

Emily Robin and other individuals who experienced adverse reactions to benzodiazepines filed this petition requesting that the FDA amend labeling for all FDA-approved benzodiazepines, including Ativan (lorazepam), Xanax (alprazolam), Klonopin (clonazepam), and Valium (diazepam), to standardize warni

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