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 · 3 docket documents 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 | Epic Pharma, LLC |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2013-P-0946 · 2 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Hydrocodone Bitartrate and Acetaminophen Tablets USP, 2.5 mg/300 mg suitable for submission as an ANDA, with the r | Other | 2013-08-26 | Open | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2013-P-0813 · 4 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client on July 2, 2013, pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare Hydrocodone Bitartrate and Acetaminophen Tablets USP in strengths of 4 mg/300 mg, 6 mg/300 mg, and | Other | 2013-07-22 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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