Treats insomnia. ANDA 91024, held by Dr Reddys. Eszopiclone.
As of Nov 14, 2026, ANDA 91024 (Eszopiclone), held by Dr Reddys, was first approved by FDA on Apr 15, 2014, with 4 approved supplements and 0 published complete response letters.
Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets are 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). Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone has been shown to decrease sleep latency and improve sleep maintenance
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2014 | Original application | Approved |
| Eszopiclone1MG · tablet;oral | Eszopiclone | Rx |
| Eszopiclone2MG · tablet;oral | Eszopiclone | Rx |
| Eszopiclone3MG · tablet;oral | Eszopiclone | Rx |
| Dec 20, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 20, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 20, 2019 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 27, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 15, 2014 | Original application | Approved |
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
