TOLMETIN SODIUM | A073290 | SENORES PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1452 · 8 docket documents 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 · 6 docket documents 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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