Manages postherpetic neuralgia. ANDA 216492, held by Rubicon Research. Gabapentin.
As of Nov 14, 2026, ANDA 216492 (Gabapentin), held by Rubicon Research, was first approved by FDA on Jan 18, 2023, with 1 approved supplement and 0 published complete response letters.
Gabapentin oral solution 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 Gabapentin oral solution 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 |
|---|---|---|---|
| Jan 18, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gabapentin250MG/5ML · solution;oral | Gabapentin | Rx |
| Aug 25, 2026 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jan 18, 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
