AMOXICILLIN; CLAVULANATE POTASSIUM | N050785 | US ANTIBIOTICS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Aurobindo Pharma USA, Inc. FDA-2024-P-2314 Aurobindo Pharma USA, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether Augmentin XR (amoxicillin and clavulanate potassium) extended-release tablets 1 gram/62.5 milligrams, NDA 050785, held by US Antibiotics, | 505(q) | 2024-05-10 | Denied | Aurobindo Pharma USA |
Citizen Petition from Aurobindo Pharma USA, Inc FDA-2019-P-5237 Aurobindo Pharma USA, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Sandoz Inc.'s approved generic Amoxicillin and Clavulanate Potassium Extended Release Tablets 1000 mg/62.5 mg (ANDA #090227) as an alternative ref | 505(q) | 2019-11-06 | Denied | Aurobindo Pharma USA |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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