PROBENECID | N007898 | MERCK AND CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Rising Pharma Holdings, Inc. FDA-2025-P-5431 Rising Pharma Holdings, Inc. filed this amendment to suitability petition FDA-2025-P-5431 on November 11, 2025, responding to an FDA information request by submitting proposed product labeling for Probenecid Tablets USP 250 mg pursuant to 21 CFR 314.93(d) in order for the FDA to complete review of R | Suitability | 2025-11-12 | Open | Rising Pharma Holdings, Inc. |
Suitability Petition from Rising Pharma Holdings, Inc. FDA-2025-P-5431 Rising Pharma Holdings, Inc. filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 CFR § 314.93, requesting permission to file an Abbreviated New Drug Application for Probenecid Tablets USP in a 250 mg strength that differs from the Refere | Suitability | 2025-10-16 | Open | Rising Pharma Holdings, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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