BUSPIRONE HYDROCHLORIDE

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BuSpar (buspirone hydrochloride tablets, USP) 15 mg and 30 mg tablets, approved under NDA 18-731, were voluntarily withdrawn or withheld from sale by Bristol Myers Squibb for reasons