ACETAMINOPHEN; CODEINE PHOSPHATE | A084445 | AH ROBINS CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from LGM Pharma Solutions, LLC FDA-2025-P-1372 LGM Pharma Solutions, LLC filed this citizen petition requesting that the FDA determine whether Phenaphen w/ Codeine No. 3 and No. 4 capsules (ANDAs A084445 and A084446), originally approved in 1982 and held by AH Robbins Co, were voluntarily withdrawn from sale for safety or efficacy reasons. The p | 505(q) | 2025-05-22 | Open | LGM Pharma Solutions |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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