LABETALOL HYDROCHLORIDE | N018687 | SCHERING CORP SUB SCHERING PLOUGH CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Amendment from Hyman, Phelps & McNamara, P.C. FDA-2025-P-7056 I don't have access to the specific content of the petition you're referring to. The title you provided indicates this is a suitability petition amendment filed by Hyman, Phelps & McNamara, P.C., but without the actual petition text detailing the drug product, requested action, and regulatory mechan | Suitability | 2026-07-02 | Denied | — |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-7056 Hyman, Phelps & McNamara, P.C., filing on behalf of a client, submitted this suitability petition pursuant to 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 Labetalol Hydrochloride Tablets in 50 mg and 150 mg strengths suitable | Suitability | 2025-12-15 | Denied | Hyman, Phelps & McNamara, P.C. |
Attachment 2 - US RLD Pack Insert of TRANDATE from Drugs@FDA (SUPPL-21 dated ... FDA-2023-P-4552 Nines Consult Pharma, LLC filed a suitability petition regarding Trandate (labetalol hydrochloride), referencing the US reference listed drug pack insert from a November 2010 FDA supplement to support their petition for regulatory determination of suitability for ANDA purposes. | Suitability | 2023-10-17 | Denied | Nines Consult Pharma, LLC |
Attachment 3 - Proposed generic Pack Insert of Labetalol Hydrochloride Inject... FDA-2023-P-4552 Nines Consult Pharma, LLC filed a suitability petition regarding a proposed generic pack insert for labetalol hydrochloride injection, likely seeking FDA confirmation that the generic formulation meets bioequivalence and manufacturing standards for approval as an ANDA. | Suitability | 2023-10-17 | Denied | Nines Consult Pharma, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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