HYDROCODONE BITARTRATE; IBUPROFEN | A077723 | STRIDES PHARMA GLOBAL PTE LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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 | — |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2007-P-0004 Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Hydrocodone Bitartrate and Homatropine Methylbromide Syrup at a lower strength of 2.5 mg/0.75 mg per 5 mL suitable for submission as an abbreviated new drug application, with the reference lis | Other | 2008-05-13 | Granted | Lachman Consultant Services |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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