NDA 21216, held by Parke Davis. Gabapentin.
As of Nov 14, 2026, NDA 21216 (Neurontin), held by Parke Davis, was first approved by FDA on Oct 12, 2000, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 12, 2000 | Original applicationTYPE 6 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Neurontin250MG/5ML · solution; oral | Gabapentin | Rx |
| Jan 30, 2002 | Supplement 1Labeling · Standard review | Approved | |
| Oct 12, 2000 | Original applicationTYPE 6 · Standard review | 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
