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, Phelps & McNamara, P.C. |
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, Phelps & McNamara, P.C. |
Citizen Petition from Bennett and Company FDA-1992-P-0330 Bennett and Company filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting permission to submit an abbreviated new drug application for lactulose crystals that would be reconstituted with water to form a liquid for oral administration, with the l | Other | 2019-01-31 | Granted | Bennett and Company |
Cumberland Pharmaceuticals Inc. - Citizen Petition FDA-2012-P-0496 Cumberland Pharmaceuticals Inc. filed this suitability petition under Section 505(j)(2)(c) requesting permission to submit an abbreviated new drug application for KRISTALOSE lactulose crystals in 10 and 20 gram formulations for prevention and treatment of portal systemic encephalopathy, using ENULOS | Other | 2012-05-18 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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