ANDA 202269, held by Novel Labs Inc. Pregabalin.
As of Nov 13, 2026, ANDA 202269 (Pregabalin), held by Novel Labs Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 23, 2014 | Original application | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pregabalin20MG/ML ยท solution;oral | Pregabalin | None (tentative approval) |
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
