ANDA 217358, held by Mankind Pharma. Divalproex Sodium.
As of Nov 14, 2026, ANDA 217358 (Divalproex Sodium), held by Mankind Pharma, was first approved by FDA on Aug 12, 2025, with 1 approved supplement and 0 published complete response letters.
Divalproex sodium delayed-release capsules are an anti-epileptic drug indicated for: 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 1.1 Epilepsy Divalproex sodium delayed-release capsules are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 12, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Divalproex SodiumEQ 125MG VALPROIC ACID · capsule, delayed rel pellets;oral | Divalproex Sodium | Rx |
| Jun 11, 2026 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 12, 2025 | 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
