ANDA 211505, held by Teva Pharms USA. Divalproex Sodium.
As of Nov 14, 2026, ANDA 211505 (Divalproex Sodium), held by Teva Pharms USA, was first approved by FDA on Nov 17, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 17, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Divalproex SodiumEQ 125MG VALPROIC ACID ยท capsule, delayed rel pellets;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