Manages postherpetic neuralgia. ANDA 216252, held by Epic Pharma LLC. Gabapentin.
As of Nov 14, 2026, ANDA 216252 (Gabapentin), held by Epic Pharma LLC, was first approved by FDA on Feb 26, 2024, with 2 approved supplements and 0 published complete response letters.
Gabapentin tablets are indicated for the management of postherpetic neuralgia. Once-daily gabapentin tablets 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: Once-daily gabapentin tablets are 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 |
|---|---|---|---|
| Feb 26, 2024 | Original application | Approved | None posted |
| Gabapentin300MG · tablet;oral | Gabapentin | Rx |
| Gabapentin600MG · tablet;oral | Gabapentin | Rx |
| Jan 7, 2026 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 7, 2026 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 26, 2024 | Original application | Approved | None posted |
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
