Manages postherpetic neuralgia. ANDA 218075, held by Annora Pharma. Gabapentin.
As of Nov 14, 2026, ANDA 218075 (Gabapentin), held by Annora Pharma, was first approved by FDA on Feb 26, 2024, with 1 approved supplement and 0 published complete response letters.
Gabapentin tablets are indicated for the management of postherpetic neuralgia. 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: 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 |
| Jul 23, 2025 | Supplement 2Labeling · 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
