Unichem Laboratories has received ANDA approval for its Divalproex Sodium Extended-Release Tablets USP, 250 mg and 500 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Depakote ER (Divalproex Sodium) Extended-Release Tablets 250 mg and 500 mg, of AbbVie Inc.
Divalproex Sodium Extended-Release Tablets are indicated for treatment of acute manic or mixed episodes associated with bipolar disorder, as monotherapy and adjunctive therapy and prophylaxis of migraine headaches. The product will be commercialized from Unichem’s Goa Plant.
Unichem Laboratories is an international, integrated, specialty pharmaceutical company.
