TORADOL

FDA-2025-P-3952

Kaylin Bower filed this citizen petition on September 10, 2025, requesting that the FDA Commissioner amend the labeling for Toradol oral (ketorolac tromethamine tablets) to clearly indicate it is approved only as an adjunctive therapy to opioid analgesia rather than as a primary therapy, arguing tha

FDA-2025-P-1136

Senores Pharmaceuticals, Inc. filed an amendment to ANDA Suitability Petition FDA-2025-P-1136 for Ketorolac Tromethamine Tablets 5 mg in response to FDA deficiencies, providing labeling information for the reference listed drug Toradol and addressing the agency's request regarding current product la

FDA-2025-P-1136

Senores Pharmaceuticals, Inc. 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 Ketorolac Tromethamine Tablets 5 mg suitable for submission in an Abbreviated New Drug Application, with the ref

FDA-2023-P-4518

Senores Pharmaceuticals Inc filed a suitability petition regarding TORADOL to request that the Food and Drug Administration determine whether the drug is suitable for inclusion in the Orange Book, which lists approved drugs and their patent and exclusivity information that is relevant to generic dru

FDA-2023-P-4518

Senores Pharmaceuticals Inc filed a suitability petition regarding proposed labeling for ketorolac tromethamine. The petition requests FDA determination on the acceptability of the proposed labeling for this nonsteroidal anti-inflammatory drug product.

FDA-2023-P-4518

Senores Pharmaceuticals, Inc. filed this ANDA suitability petition under section 505(j)(2)(C) requesting FDA approval to submit an abbreviated new drug application for Ketorolac Tromethamine 10 mg Orally Disintegrating Tablets, which would differ in dosage form from the reference listed drug TORADOL

FDA-2021-P-1209

Senores Pharmaceuticals, Inc. filed a citizen petition regarding labeling for a ketorolac 10 mg product and its suitability for regulatory purposes. The petition requests FDA action on the labeling designation and regulatory classification of this ketorolac formulation.

FDA-2021-P-1209

Senores Pharmaceuticals, Inc. submitted an ANDA Suitability Petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA determination that Ketorolac Tromethamine 10 mg Orally Disintegrating Tablets is suitable for submission in an ANDA, differing in dosage form fro

FDA-1997-P-0073

Bedford Laboratories filed this citizen petition on May 21, 1997, under Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare Ketorolac Tromethamine Injection, 30 mg/mL in 10 mL multiple-dose vials suitable for an abbreviated new drug application (ANDA) as