ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | A211499 | ABHAI LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Nostrum Laboratories, Inc. FDA-2023-P-4617 Nostrum Laboratories, Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Oxycodone Hydrochloride and Acetaminophen Oral Solution in three new strengths—2.5 mg/325 mg per 5 mL, 7.5 mg/325 mg per 5 mL, and 10 mg/32 | Suitability | 2023-10-20 | Open | Nostrum Laboratories |
Suitability Petition from Nostrum Laboratories Inc FDA-2022-P-0966 Nostrum Laboratories, Inc. submitted a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Oxycodone Hydrochloride and Acetaminophen Oral Solution in strengths of 2.5 mg/325 mg per 5 mL, 7.5 mg/325 mg per 5 mL, and 10 mg/3 | Suitability | 2022-06-01 | Open | Nostrum Laboratories Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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