ANDA 75678, held by Actavis Elizabeth. Pemoline.
As of Nov 13, 2026, ANDA 75678 (Pemoline), held by Actavis Elizabeth, was first approved by FDA on Jul 26, 2000, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pemoline37.5MG ยท tablet, chewable;oral | Pemoline | 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
