Treats insomnia. ANDA 91124, held by Lupin Ltd. Eszopiclone.
As of Nov 14, 2026, ANDA 91124 (Eszopiclone), held by Lupin Ltd, was first approved by FDA on Sep 13, 2011, with 2 approved supplements and 0 published complete response letters.
Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablet has been shown to decrease sleep latency and improve sleep maintenance Eszopiclone tablet is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 13, 2011 | Original application | Approved | None posted |
| Eszopiclone1MG · tablet;oral | Eszopiclone | Discontinued |
| Eszopiclone2MG · tablet;oral | Eszopiclone | Discontinued |
| Eszopiclone3MG · tablet;oral | Eszopiclone | Discontinued |
| Mar 19, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 19, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 13, 2011 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
