LABETALOL HYDROCHLORIDE | A075113 | AIPING PHARMACEUTICAL INC
| 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 | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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