ANDA 203087, held by Pharmobedient. Eszopiclone.
As of Nov 14, 2026, ANDA 203087 (Eszopiclone), held by Pharmobedient, was first approved by FDA on May 8, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 8, 2019 | Original application | Approved | None posted |
| Eszopiclone1MG · tablet;oral | Eszopiclone | Discontinued |
| Eszopiclone2MG · tablet;oral | Eszopiclone | Discontinued |
| Eszopiclone3MG · tablet;oral | Eszopiclone | Discontinued |
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
