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 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 · 10 docket documents

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 · 8 docket documents

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 · 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