ESZOPICLONE | A091103 | SUN PHARMACEUTICAL INDUSTRIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Daniel F. Kripke, MD (The Weston Firm) FDA-2015-P-3959 · 6 docket documents Dr. Daniel F. Kripke filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA take multiple administrative actions regarding hypnotic drugs including zolpidem, temazepam, eszopiclone, zaleplon, triazolam, flurazepam, quazepam, and barbiturates such as pentobarbital, amobarbital, a | Other | 2015-12-16 | Open | Daniel F. Kripke, MD (The Weston Firm) |
Sepracor, Inc. - Citizen Petition FDA-2006-P-0137 · 7 docket documents Sepracor Inc. filed this citizen petition on December 30, 2005, requesting that the FDA Commissioner confirm that the approval of the NDA for Lunesta (eszopiclone) tablets became effective on April 4, 2005 (the date of DEA scheduling completion), rather than December 15, 2004 (the date of the approv | 505(q) | 2008-08-20 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.