Treats manic episodes associated with bipolar disorder Monotherapy and adjunctive therapy…. ANDA 78755, held by Dr Reddys Labs Ltd. Divalproex Sodium.
As of Nov 14, 2026, ANDA 78755 (Divalproex Sodium), held by Dr Reddys Labs Ltd, was first approved by FDA on Jul 29, 2008, with 2 approved supplements and 0 published complete response letters.
Divalproex sodium delayed-release tablet is an anti-epileptic drug indicated for: Treatment of manic episodes associated with bipolar disorder 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 delayed-release tablet is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 29, 2008 | Original application | Approved | None posted |
| Divalproex SodiumEQ 125MG VALPROIC ACID · tablet, delayed release;oral | Divalproex Sodium | Rx |
| Divalproex SodiumEQ 250MG VALPROIC ACID · tablet, delayed release;oral | Divalproex Sodium | Rx |
| Divalproex SodiumEQ 500MG VALPROIC ACID · tablet, delayed release;oral | Divalproex Sodium | Rx |
| Nov 8, 2014 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 21, 2011 | Supplement 1Labeling | Approved | None posted |
| Jul 29, 2008 | 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
