TOLECTIN DS

FDA-2026-P-7180

Senores Pharmaceuticals, Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA authorization to submit an Abbreviated New Drug Application for Tolmetin Capsules in 150 mg and 300 mg strengths, which differ from the Reference Listed

FDA-2026-P-1833

Senores Pharmaceuticals, Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Tolmetin Capsules 600 mg, which would differ in strength from the reference listed drug Tolec

FDA-2026-P-1820

Senores Pharmaceuticals, Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Tolmetin Capsules 200 mg is suitable for submission in an Abbreviated New Drug Application (ANDA), with the reference listed dru

FDA-2025-P-3575

Senores Pharmaceuticals, Inc. filed this ANDA citizen petition requesting that the FDA determine whether TOLECTIN DS (Tolmetin Capsules 200 mg), approved under NDA 018084 and held by Ortho McNeil Janssen Pharmaceuticals Inc., was withdrawn from the market for reasons of safety or effectiveness, or a

FDA-2025-P-1454

Senores Pharmaceuticals, Inc. filed this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA authorization to submit an Abbreviated New Drug Application for Tolmetin Capsules 600 mg, a nonsteroidal anti-inflammatory drug that differs in st

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