Manages postherpetic neuralgia. ANDA 218491, held by Sciegen Pharms. Gabapentin.
As of Nov 14, 2026, ANDA 218491 (Gabapentin), held by Sciegen Pharms, was first approved by FDA on Sep 19, 2025, with 0 approved supplements and 0 published complete response letters.
Gabapentin tablets (Once-Daily) are indicated for the management of postherpetic neuralgia. Gabapentin tablets (Once-Daily) are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. Gabapentin tablets are indicated for the management of Postherpetic Neuralgia (PHN). Important Limitation: Gabapentin tablets (Once-Daily) is not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration ( See Warnings and Precautions )
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 19, 2025 | 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
