Manages postherpetic neuralgia. ANDA 217116, held by Granules. Gabapentin.
As of Nov 14, 2026, ANDA 217116 (Gabapentin), held by Granules, was first approved by FDA on Mar 28, 2023, with 2 approved supplements and 0 published complete response letters.
Gabapentin tablets are indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin tablets are indicated for: Postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 28, 2023 | Original application | Approved | None posted |
| Gabapentin600MG · tablet;oral | Gabapentin | Rx |
| Gabapentin800MG · tablet;oral | Gabapentin | Rx |
| Jul 23, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 13, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 28, 2023 | 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
