ANDA 77261, held by Taro. Gabapentin.
As of Nov 14, 2026, ANDA 77261 (Gabapentin), held by Taro, was first approved by FDA on Aug 2, 2013, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 2, 2013 | Original application | Approved | None posted |
| Gabapentin100MG · capsule;oral | Gabapentin | Discontinued |
| Gabapentin300MG · capsule;oral | Gabapentin | Discontinued |
| Gabapentin400MG · capsule;oral | Gabapentin | Discontinued |
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
