ACETAMINOPHEN; HYDROCODONE BITARTRATE | A040658 | CHARTWELL SCHEDULED LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from PuraCap Pharmaceutical, LLC on behalf of Epic Pharma, LLC FDA-2018-P-1891 PuraCap Pharmaceutical, LLC, on behalf of Epic Pharma, LLC, filed this citizen petition on May 11, 2018, requesting that the FDA Commissioner assign a new Reference Standard for Hydrocodone Bitartrate and Acetaminophen Tablets USP in three strengths (5 mg/300 mg, 7.5 mg/300 mg, and 10 mg/300 mg) bec | Other | 2018-05-16 | Open | PuraCap Pharmaceutical |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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