Manages postherpetic neuralgia. ANDA 91286, held by Ajenat Pharms. Gabapentin.
As of Nov 14, 2026, ANDA 91286 (Gabapentin), held by Ajenat Pharms, was first approved by FDA on Mar 14, 2016, with 3 approved supplements 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 |
|---|---|---|---|
| Mar 14, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gabapentin250MG/5ML · solution;oral | Gabapentin | Rx |
| Aug 7, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 7, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 7, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 14, 2016 | 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
