KETOROLAC TROMETHAMINE | A074754 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 Most Recent Labeling for ANDA 074754 re Suitability Petition fro... FDA-2023-P-4518 I cannot provide a summary of this citizen petition based on the text provided. The document appears to be only a title page or cover sheet referencing ANDA 074754 for Senores Pharmaceuticals Inc, but it contains no substantive information about the petitioner's identity, the specific drug product i | Suitability | 2023-10-16 | Open | Senores Pharmaceuticals Inc |
Suitability Petition from Senores Pharmaceuticals, Inc. 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 | Suitability | 2023-10-16 | Open | Senores Pharmaceuticals |
Suitability Petition from Senores Pharmaceuticals, Inc. 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 | Suitability | 2021-11-08 | Open | Senores Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.