ANDA 203611, held by Actavis Elizabeth. Gabapentin.
As of Nov 14, 2026, ANDA 203611 (Gabapentin), held by Actavis Elizabeth, was first approved by FDA on Jun 23, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 2026 | Original application | Approved | None posted |
| Gabapentin300MG · tablet;oral | Gabapentin | Rx |
| Gabapentin600MG · tablet;oral | Gabapentin | Rx |
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
