ANDA 215527, held by Annora Pharma. Divalproex Sodium.
As of Nov 14, 2026, ANDA 215527 (Divalproex Sodium), held by Annora Pharma, was first approved by FDA on Sep 26, 2023, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 26, 2023 | Original application | Approved | None posted |
| Divalproex SodiumEQ 250MG VALPROIC ACID · tablet, extended release;oral | Divalproex Sodium | Rx |
| Divalproex SodiumEQ 500MG VALPROIC ACID · tablet, extended release;oral | Divalproex Sodium | Rx |
| Apr 15, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 29, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 26, 2023 | Original application | Approved | None posted |
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
