ANDA 77254, held by Mylan. Divalproex Sodium.
As of Nov 14, 2026, ANDA 77254 (Divalproex Sodium), held by Mylan, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 9, 2006 | Original application | Tentative approval | None posted |
| Divalproex SodiumEQ 125MG VALPROIC ACID · tablet, delayed release;oral | Divalproex Sodium | Discontinued |
| Divalproex SodiumEQ 250MG VALPROIC ACID · tablet, delayed release;oral | Divalproex Sodium | Discontinued |
| Divalproex SodiumEQ 500MG VALPROIC ACID · tablet, delayed release;oral | Divalproex Sodium | 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