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 The law firm Hyman, Phelps & McNamara filed this suitability petition amendment pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that FDA declare Labetalol Hydrochloride Tablets in 50 mg and 150 mg strengths suitable for submission as an A | 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 | Open | Hyman |
Attachment 1 - Current (October 06, 2023) Orange Book Listing of RLD TRANDATE... FDA-2023-P-4552 Nines Consult Pharma, LLC filed a suitability petition regarding TRANDATE (Labetalol Hydrochloride) Injection USP, 5 mg/mL, the reference listed drug under NDA #019425 held by Sebela Ireland LTD, seeking a determination on the suitability of the reference product for use in establishing bioequivalen | Suitability | 2023-10-17 | Open | Nines Consult Pharma |
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 | Open | Nines Consult Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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