ANDA 203643, held by Abon Pharms LLC. Gabapentin.
As of Nov 14, 2026, ANDA 203643 (Gabapentin), held by Abon Pharms LLC, was first approved by FDA on Sep 9, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 9, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gabapentin600MG ยท 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
