Manages postherpetic neuralgia. ANDA 206402, held by Alkem Labs Ltd. Gabapentin.
As of Nov 14, 2026, ANDA 206402 (Gabapentin), held by Alkem Labs Ltd, was first approved by FDA on Dec 23, 2015, with 8 approved supplements and 0 published complete response letters.
Gabapentin 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 23, 2015 | Original application | Approved | None posted |
| Gabapentin600MG · tablet;oral | Gabapentin | Rx |
| Gabapentin800MG · tablet;oral | Gabapentin | Rx |
| Apr 2, 2026 | Supplement 27Labeling · Standard review | Approved | None posted |
| Dec 17, 2024 | Supplement 26Labeling · Standard review | Approved | None posted |
| Mar 31, 2022 | Supplement 20Labeling · Standard review | Approved | None posted |
| Apr 29, 2021 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 29, 2021 | Supplement 5Labeling · Standard review | Approved | None posted |
| Apr 29, 2021 | Supplement 14Labeling · Standard review | Approved | None posted |
| Apr 29, 2021 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jan 9, 2017 | Supplement 1Manufacturing | Approved | None posted |
| Dec 23, 2015 | 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
