Manages postherpetic neuralgia. ANDA 219319, held by Pharmazone. Gabapentin.
As of Nov 14, 2026, ANDA 219319 (Gabapentin), held by Pharmazone, was first approved by FDA on Aug 7, 2025, with 1 approved supplement 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 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 |
|---|---|---|---|
| Aug 7, 2025 | Original application | Approved |
| Gabapentin100MG · capsule;oral | Gabapentin | Rx |
| Gabapentin300MG · capsule;oral | Gabapentin | Rx |
| Gabapentin400MG · capsule;oral | Gabapentin | Rx |
| Gabapentin200MG · capsule;oral | Gabapentin | Rx |
| May 14, 2026 | Supplement 1Manufacturing | Approved | None posted |
| Aug 7, 2025 | Original application | Approved |
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
