BUSPIRONE HYDROCHLORIDE | A074253 | IMPAX LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petion Amendment from Epic Pharma, LLC 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 | Suitability | 2023-08-18 | Granted | — |
Suitability Petition from Lachman Consultant Services Inc 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 | Suitability | 2023-04-18 | Granted | Lachman Consultant Services Inc |
Lachman Consultant Services, Inc. - Citizen Petition 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BuSpar (buspirone hydrochloride tablets, USP) 15 mg and 30 mg tablets, approved under NDA 18-731, were voluntarily withdrawn or withheld from sale by Bristol Myers Squibb for reasons | 505(q) | 2010-05-12 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.