CLONIDINE HYDROCHLORIDE | N020615 | MYLAN INSTITUTIONAL LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Arent Fox LLP - Citizen Petition FDA-2012-P-0050 · 3 docket documents Arent Fox LLP filed this citizen petition on January 10, 2012, requesting that the FDA Commissioner determine that Shionogi Inc.'s Jenloga (clonidine hydrochloride) 0.1 mg and 0.2 mg extended-release tablets and Kapvay (clonidine hydrochloride) 0.2 mg extended-release tablets, both approved under ND | 505(q) | 2012-01-24 | Open | — |
Actavis Inc. - Citizen Petition FDA-2011-P-0291 · 5 docket documents Actavis Inc. filed this citizen petition on April 20, 2011, requesting that the FDA determine that JENLOGA (clonidine hydrochloride) Extended-Release Tablets in 0.1 mg and 0.2 mg strengths, approved under NDA 22-331, were not voluntarily withdrawn for safety or efficacy reasons. Actavis sought this | 505(q) | 2011-04-29 | Granted | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2008-P-0489 · 3 docket documents Lachman Consultant Services, Inc. filed this citizen petition requesting that the FDA take action regarding clonidine hydrochloride products listed in the Orange Book, specifically seeking clarification or regulatory action on the abbreviated new drug applications (ANDAs) and reference listed drug d | Other | 2008-09-15 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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