Manages postherpetic neuralgia. ANDA 211314, held by Strides Pharma. Gabapentin.
As of Nov 14, 2026, ANDA 211314 (Gabapentin), held by Strides Pharma, was first approved by FDA on Oct 16, 2018, with 5 approved supplements and 0 published complete response letters.
Gabapentin capsules are 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 capsules are 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 |
|---|---|---|---|
| Oct 16, 2018 | Original application | Approved | None posted |
| Gabapentin100MG · capsule;oral | Gabapentin | Rx |
| Gabapentin300MG · capsule;oral | Gabapentin | Rx |
| Gabapentin400MG · capsule;oral | Gabapentin | Rx |
| Nov 24, 2025 | Supplement 18Labeling · Standard review | Approved | None posted |
| Jul 21, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jul 21, 2025 | Supplement 17Labeling · Standard review | Approved | None posted |
| Feb 4, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 4, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 16, 2018 | 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
