ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | A089351 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lachman Consultant Services, Inc FDA-2018-P-1492 · 4 docket documents Lachman Consultant Services, Inc. filed this petition requesting that the FDA determine whether Roxicet (Acetaminophen and Oxycodone Hydrochloride) Oral Solution, 325 mg/5 mL, 5 mg/5 mL was voluntarily withdrawn for safety or effectiveness reasons, and if not, to designate it as the reference listed | 505(q) | 2018-04-12 | Withdrawn | Lachman Consultant Services, Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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