KETOROLAC TROMETHAMINE | N019698 | ROCHE PALO ALTO LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3 Proposed Labeling for Ketorolac Tromethamine re Suitability Peti... 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. | Suitability | 2023-10-16 | Open | Senores Pharmaceuticals Inc |
Attachment 1 Orange Book for TORADOL re Suitability Petition from Senores Pha... 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 | Suitability | 2023-10-16 | Open | Senores Pharmaceuticals Inc |
Citizen Petition from Bedford Laboratories 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 | Other | 2017-08-30 | Granted | Bedford Laboratories |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.