Sun Pharmaceutical Industries received tentative approval from US FDA for its abbreviated new drug application for generic Depakote – Divalproex Sodium delayed release tablets of 125 mg, 250 mg and 500 mg strengths.

Sun Pharmaceuticals has obtained tentative approval from the USFDA for its abbreviated new drug application (ANDA) for Divalproex Sodium delayed release tablets, the generic version of Abbott's Depakote.

Divalproex Sodium delayed release tablets are indicated for monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures, as sole and adjunct therapy for patients with simple and complex absence seizures, for manic episodes with bipolar disorders and for prophylaxis of migraine headaches. Depakote delayed release tablets have annual sales of about $755 million in US.