ANDA 213181, held by Ajanta Pharma Ltd. Divalproex Sodium.
As of Nov 14, 2026, ANDA 213181 (Divalproex Sodium), held by Ajanta Pharma Ltd, was first approved by FDA on Feb 28, 2020, with 7 approved supplements 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 |
|---|---|---|---|
| Feb 28, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Divalproex SodiumEQ 125MG VALPROIC ACID · capsule, delayed rel pellets;oral | Divalproex Sodium | Rx |
| Nov 3, 2026 | Supplement 22Labeling · Standard review | Approved | None posted |
| Nov 3, 2026 | Supplement 23Labeling · Standard review | Approved | None posted |
| Nov 3, 2026 | Supplement 26Labeling · Standard review | Approved | None posted |
| Jul 15, 2024 | Supplement 18Labeling · Standard review | Approved | None posted |
| Oct 23, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jan 25, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 25, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Feb 28, 2020 | 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
