HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | A088008 | PHARMOBEDIENT CONSULTING LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lachman Consultant Services, Inc. FDA-2007-P-0004 · 8 docket documents 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, Inc. |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2007-P-0176 · 7 docket documents Lachman Consultant Services, Inc. filed this citizen petition on August 2, 2007, pursuant to Section 505(j)(2)(C) requesting that the FDA declare Hydrocodone Bitartrate and Homatropine Methylbromide Capsules, 5 mg/1.5 mg, suitable for submission as an abbreviated new drug application based on the re | Other | 2008-05-06 | Withdrawn | — |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2007-P-0124 · 7 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA declare Hydrocodone Bitartrate and Homatropine Methylbromide Tablets at 2.5 mg/0.75 mg suitable for submission as an ANDA, with the reference listed drug being Hycodan at 5 mg/1.5 mg (NDA 05-2 | Other | 2008-04-18 | Granted | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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