ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | A087003 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Nostrum Laboratories, Inc. FDA-2025-P-0410 Nostrum Laboratories, Inc. filed this citizen petition under 21 CFR 10.25(a) and 10.30 requesting that the FDA determine whether Roxicet (Oxycodone Hydrochloride and Acetaminophen) Tablets, 5 mg/325 mg (PANDA #087003), owned by Hikma Pharmaceuticals USA Inc., was voluntarily withdrawn from sale for | 505(q) | 2025-02-06 | Withdrawn | Nostrum Laboratories |
Suitability Petition from Nostrum Laboratories, Inc. FDA-2025-P-0336 Nostrum Laboratories, Inc. submitted this suitability petition pursuant to Section 505(j)(2)(C) requesting that the FDA declare Oxycodone Hydrochloride and Acetaminophen Oral Solution in three additional strengths (2.5 mg/325 mg per 5 mL, 7.5 mg/325 mg per 5 mL, and 10 mg/325 mg per 5 mL) suitable f | Suitability | 2025-01-30 | Open | Nostrum Laboratories |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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