Manages postherpetic neuralgia. ANDA 75477, held by Cspc Ouyi. Gabapentin.
As of Nov 14, 2026, ANDA 75477 (Gabapentin), held by Cspc Ouyi, was first approved by FDA on Mar 23, 2005, with 5 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 |
|---|---|---|---|
| Mar 23, 2005 | Original application | Approved | None posted |
| Gabapentin100MG · capsule;oral | Gabapentin | Rx |
| Gabapentin300MG · capsule;oral | Gabapentin | Rx |
| Gabapentin400MG · capsule;oral | Gabapentin | Rx |
| Oct 11, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 11, 2024 | Supplement 9Labeling · Standard review | Approved | None posted |
| Oct 11, 2024 | Supplement 10Labeling · Standard review | Approved | None posted |
| Nov 4, 2015 | Supplement 6Labeling | Approved | None posted |
| Jan 31, 2006 | Supplement 2Labeling | Approved | None posted |
| Mar 23, 2005 | 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
