NDA 21397, held by Parke Davis. Gabapentin.
As of Nov 14, 2026, NDA 21397 (Neurontin), held by Parke Davis, was first approved by FDA on May 24, 2002, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 24, 2002 | Original applicationTYPE 6 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Neurontin600MG · tablet; oral | Gabapentin | Rx |
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
