ACETAMINOPHEN; HYDROCODONE BITARTRATE | A040148 | ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
FDA/CDER to Lachman Consultant Services, Inc. - Petition Denial FDA-2011-P-0302 Lachman Consultant Services, Inc. filed a petition on April 26, 2011 requesting permission to file an ANDA for Hydrocodone Bitartrate and Acetaminophen Effervescent Tablets in strengths of 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg, referencing Norco as the listed drug. The FDA deni | Other | 2012-08-10 | Denied | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2011-P-0302 Lachman Consultant Services, Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Hydrocodone Bitartrate and Acetaminophen Effervescent Tablets in strengths of 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 | Other | 2011-05-25 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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