TORADOL

FDA-2025-P-3952 · 3 docket documents

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 · 8 docket documents

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-2023-P-4518 · 10 docket documents

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-2021-P-1209 · 8 docket documents

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-1997-P-0073 · 5 docket documents

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