LACTULOSE | N017884 | SANOFI AVENTIS US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-4150 Hyman, Phelps & McNamara, P.C., on behalf of a client, filed an amendment to a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Lactulose for Oral Solution, 15 g/Packet, suitable for submission as an Abbreviated New Drug Appli | Suitability | 2025-10-15 | Open | Hyman |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-4150 The law firm Hyman, Phelps & McNamara submitted a 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 Lactulose for Oral Solution, 15 g/Packet, suitable for submission as an AN | Suitability | 2025-09-23 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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