BUSPAR

FDA-2026-P-7195 · 8 docket documents

Senores Pharmaceuticals, Inc. filed this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Buspirone Capsules in strengths of 2.5 mg, 12.5 mg, 20 mg, and 30 mg suitable for submission in an ANDA, based on the approved re

FDA-2022-P-1039 · 7 docket documents

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 · 4 docket documents

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 · 5 docket documents

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Hydrochloride) Capsules 5 mg, 7.5 mg, 10 mg, and 15 mg, approved under NDA 021190 by Bristol Myers Squibb, were withdrawn from the market for s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 · 5 docket documents

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BuSpar (buspirone hydrochloride tablets, USP) 15 mg and 30 mg tablets, approved under NDA 18-731, were voluntarily withdrawn or withheld from sale by Bristol Myers Squibb for reasons