LABETALOL HYDROCHLORIDE | A075113 | AIPING PHARMACEUTICAL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Amendment from Hyman, Phelps & McNamara, P.C. FDA-2025-P-7056 · 9 docket documents The law firm Hyman, Phelps & McNamara, P.C., filed this suitability petition amendment under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Labetalol Hydrochloride Tablets in 50 mg and 150 mg strengths suitable for submission as an ANDA, with Schering Cor | Suitability | 2026-07-02 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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