KETOROLAC TROMETHAMINE

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-2020-P-0745 · 4 docket documents

Fox Rothschild LLP filed this citizen petition requesting that FDA designate ANDA 074754 held by Teva Pharmaceuticals USA Inc. as the reference standard for Ketorolac Tromethamine Tablets, 10 mg, to replace the current reference standard under ANDA 074761 held by Mylan Pharmaceuticals Inc., which is