METHYLPHENIDATE | N021514 | NOVEN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Noven Pharmaceuticals, Inc. FDA-2013-P-1710 Noven Pharmaceuticals, Inc. filed a citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to approve any abbreviated new drug application for a generic version of Daytrana (methylphenidate transdermal system) unless the applicant demonstrate | 505(q) | 2014-01-24 | Denied | Noven Pharmaceuticals |
| Other | 2012-04-12 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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