IBUPROFEN | N020516 | KENVUE BRANDS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-5975 The law firm Hyman, Phelps & McNamara, P.C., filed this suitability petition under 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 Ibuprofen Oral Suspension, 200 mg/5 mL, suitable for submission as an ANDA, with Children's Motrin | Suitability | 2026-05-27 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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