- Unichem Laboratories Limited is announce that it 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 receives USFDA approval for Divalproex ER Tablets
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