ANDA 206222, held by Ipca Labs Ltd. Eszopiclone.
As of Nov 14, 2026, ANDA 206222 (Eszopiclone), held by Ipca Labs Ltd, was first approved by FDA on Dec 29, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 29, 2023 | 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
