BUSPAR

FDA-2026-P-7195

Senores Pharmaceuticals, Inc. filed a suitability petition requesting FDA determination that a particular drug substance or formulation is suitable for use in an abbreviated new drug application (ANDA), seeking regulatory guidance to support the development and approval pathway for their pharmaceuti

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-2023-P-0120

Epic Pharma, LLC submitted this petition under Section 505(j)(2)(C) of the FD&C Act to request that the FDA Commissioner determine whether Buspar (Buspirone Hydrochloride) Capsules 5 mg, 7.5 mg, 10 mg, and 15 mg, approved under NDA 021190 by Bristol Myers Squibb, were withdrawn from the market for s

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BuSpar (buspirone hydrochloride tablets, USP) 15 mg and 30 mg tablets, approved under NDA 18-731, were voluntarily withdrawn or withheld from sale by Bristol Myers Squibb for reasons