ANDA 75726, held by Mallinckrodt. Pemoline.
As of Nov 13, 2026, ANDA 75726 (Pemoline), held by Mallinckrodt, was first approved by FDA on Mar 30, 2001, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 30, 2001 | Original application | 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
