Treats manic or mixed episodes associated with bipolar disorder, with or without…. ANDA 214643, held by Unichem. Divalproex Sodium.
As of Nov 14, 2026, ANDA 214643 (Divalproex Sodium), held by Unichem, was first approved by FDA on Feb 25, 2022, with 5 approved supplements and 0 published complete response letters.
Divalproex sodium extended-release tablets are indicated for: Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures Prophylaxis of migraine headaches 1.1 Mania Divalproex sodium extended-release tablets are valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 25, 2022 | 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 |
| Jun 12, 2026 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jan 28, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jan 28, 2026 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jun 3, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jun 9, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 25, 2022 | 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
