Manages postherpetic neuralgia. ANDA 211330, held by Pai Holdings Pharm. Gabapentin.
As of Nov 14, 2026, ANDA 211330 (Gabapentin), held by Pai Holdings Pharm, was first approved by FDA on Dec 3, 2019, with 5 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 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 |
|---|---|---|---|
| Dec 3, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gabapentin250MG/5ML · solution;oral | Gabapentin | Rx |
| Sep 16, 2026 | Supplement 7Labeling · Standard review | Approved | None posted |
| Sep 16, 2026 | Supplement 8Labeling · Standard review | Approved | None posted |
| Feb 18, 2025 | Supplement 6Manufacturing | Approved | None posted |
| Jun 25, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 25, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 3, 2019 | 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
