Manages postherpetic neuralgia. ANDA 206943, held by Strides Pharma. Gabapentin.
As of Nov 14, 2026, ANDA 206943 (Gabapentin), held by Strides Pharma, was first approved by FDA on May 14, 2018, with 6 approved supplements and 0 published complete response letters.
Gabapentin Capsules, USP 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, USP 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 |
|---|---|---|---|
| May 14, 2018 | Original application | Approved | None posted |
| Gabapentin100MG · capsule;oral | Gabapentin | Rx |
| Gabapentin300MG · capsule;oral | Gabapentin | Rx |
| Gabapentin400MG · capsule;oral | Gabapentin | Rx |
| Apr 2, 2026 | Supplement 24Labeling · Standard review | Approved | None posted |
| Dec 19, 2024 | Supplement 12Labeling · Standard review | Approved | None posted |
| Dec 19, 2024 | Supplement 21Labeling · Standard review | Approved | None posted |
| Dec 19, 2024 | Supplement 22Labeling · Standard review | Approved | None posted |
| Sep 16, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 16, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| May 14, 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
