CLONIDINE HYDROCHLORIDE | N022331 | CONCORDIA PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Arent Fox LLP - Citizen Petition FDA-2012-P-0050 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 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hydrochloride) Extended-Release Tablets in 0.1 mg and 0.2 mg strengths, approved under NDA 22-331, were not voluntarily withdrawn for safety or efficacy reasons.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 | — |
Actavis Inc. - Citizen Petition FDA-2011-P-0292 Actavis Inc. submitted this citizen petition on April 20, 2011 requesting that the FDA determine that KAPVAY (clonidine hydrochloride) Extended-Release Tablets, 0.2 mg, approved under NDA 22-331, was not voluntarily withdrawn for safety or efficacy reasons, as the product was never commercially mark | 505(q) | 2011-04-29 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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