BUSPAR

FDA-2026-P-7531

Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding the use of a new excipient or process in pharmaceutical development. The petition requests that FDA determine whether the proposed excipient or manufacturing process meets the agency's standards for safety and suitability in drug

FDA-2026-P-2302

The law firm Hyman, Phelps & McNamara filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Buspirone Tablets, 20 mg, suitable for submission as an Abbreviated New Drug Application, with BUSPAR (bu

FDA-2025-P-6524

The law firm Hyman, Phelps & McNamara, P.C., on behalf of a client, filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Buspirone HCl Oral Solution, 2 mg/mL, suitable for submission as an Abbreviated New Drug Applicati

FDA-2024-P-0545

Hyman, Phelps & McNamara P.C., on behalf of a client, filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Buspirone HCl Oral Solution, 2 mg/mL, suitable for submission as an Abbreviated New Drug Application, with the refe

FDA-2022-P-1039

Epic Pharma, LLC filed this suitability petition amendment on August 16, 2023 (FDA-2022-P-1039), submitted in response to an FDA information request, providing proposed drug product labeling for Buspirone Hydrochloride Tablets USP in 2.5 mg, 3.75 mg, and 12.5 mg strengths pursuant to 21 CFR 314.93(d

FDA-1998-P-0252

Lachman Consultant Services Inc filed a petition regarding buspirone hydrochloride tablets, USP, an antianxiety agent indicated for the management of anxiety disorders and short-term relief of anxiety symptoms. The document provides background material on the drug's description, clinical pharmacolog

FDA-1998-P-0252

Lachman Consultant Services Inc filed this petition on behalf of a client requesting that the FDA declare a 7.5 mg strength of Buspirone Hydrochloride Tablet suitable for submission as an ANDA under section 505(j)(2)(C), using BuSpar Tablets as the reference-listed drug. The petitioner argues that t

FDA-2022-P-1039

Epic Pharma, LLC submitted this citizen petition on June 7, 2022, pursuant to section 505(j)(2)(C) of the FD&C Act requesting FDA approval to file an Abbreviated New Drug Application for Buspirone Hydrochloride Tablets, USP in new strengths of 2.5 mg, 3.75 mg, and 12.5 mg, based on the reference lis

FDA-2010-P-0234

Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA determine whether BuSpar (buspirone hydrochloride tablets, USP) 15 mg and 30 mg tablets, approved under NDA 18-731, were voluntarily withdrawn or withheld from sale by Bristol Myers Squibb for reasons