Manages postherpetic neuralgia. ANDA 211313, held by Strides Pharma. Gabapentin.
As of Nov 14, 2026, ANDA 211313 (Gabapentin), held by Strides Pharma, was first approved by FDA on Mar 4, 2024, with 2 approved supplements and 0 published complete response letters.
GABARONE is 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 GABARONE is 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 4, 2024 | Original application | Approved | None posted |
| Gabapentin600MG · tablet;oral | Gabapentin | Rx |
| Gabapentin800MG · tablet;oral | Gabapentin | Rx |
| Gabapentin100MG · tablet;oral | Gabapentin | Rx |
| Gabapentin400MG · tablet;oral | Gabapentin | Rx |
| Sep 5, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 5, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 4, 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
