DEXTROAMPHETAMINE SULFATE | N017078 | IMPAX LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lachman Consultant Services, Inc. FDA-2005-P-0328 · 6 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 determine that Abbreviated New Drug Applications may be submitted for Dextroamphetamine Sulfate Tablets in strengths of 2 | Other | 2009-04-02 | Withdrawn | Lachman Consultant Services, Inc. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2006-P-0023 · 6 docket documents Lachman Consultant Services, Inc. filed this petition on June 23, 2006 under Section 505(j)(2)(C) requesting that the FDA determine that an Abbreviated New Drug Application may be submitted for Dextroamphetamine Sulfate Tablets in strengths of 2.5 mg, 7.5 mg, 15 mg, 20 mg and 30 mg, which differ fro | Other | 2008-08-25 | Granted | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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