ANDA 220420, held by Annora Pharma Private Limited. Gabapentin Enacarbil.
As of Nov 15, 2026, ANDA 220420 (Gabapentin Enacarbil), held by Annora Pharma Private Limited, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 20, 2026 | Original application | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gabapentin Enacarbil600MG ยท tablet, extended release | Gabapentin Enacarbil | None (tentative approval) |
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
