TOLMETIN SODIUM | A073290 | SENORES PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Amendment from Senores Pharmaceuticals, Inc. FDA-2026-P-7180 Senores Pharmaceuticals, Inc. filed an amendment to a suitability petition requesting that the FDA reconsider its prior finding of unsuitability for a reference listed drug suitable for generic ANDA development, with the stated goal of enabling the company to pursue an abbreviated new drug applicati | Suitability | 2026-08-06 | Open | — |
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1452 Senores Pharmaceuticals, Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act to request FDA determination that Tolmetin Capsules 200 mg is suitable for submission in an Abbreviated New Drug Application, allowing the company to submit an ANDA fo | Suitability | 2025-05-30 | Denied | Senores Pharmaceuticals, Inc. |
Citizen Petition from Quantum Pharmics, Ltd. FDA-1990-P-0044 Quantum Pharmics, Ltd. filed this citizen petition under section 505(j)(2)(c) of the Federal Food and Drug Act on January 9, 1990, requesting permission to file an Abbreviated New Drug Application for Tolmetin Sodium Tablets, USP, 400 mg, which differs from the listed drug Tolectin 600 (tolmetin sod | Other | 2017-07-17 | Granted | Quantum Pharmics, Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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