DIPHENHYDRAMINE HYDROCHLORIDE | A040498 | PHARMOBEDIENT CONSULTING LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & MCNamara, P.C. FDA-2023-P-4371 Law firm Hyman, Phelps & McNamara, P.C., on behalf of a client, filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that FDA declare Diphenhydramine Hydrochloride Injection in a new 500 mg/10 mL strength suitable for submission as a | Suitability | 2023-10-06 | Open | Hyman |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2023-P-2289 The law firm Hyman, Phelps & McNamara, P.C., filed this suitability petition on behalf of a client 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 Diphenhydramine Hydrochloride Injection, 500 mg/10 mL (50 mg/mL), su | Suitability | 2023-06-07 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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