Consultants to the Pharmaceutical and Allied Industries

The petitioner requests that the Commissioner of the Food and Drug Administration declare that the drug product Divalproex Sodium Extended-Release Tablets, 1000 mg, is suitable for submissiol as an ANDA. The reference-listed drug product upon which this petition is based is Depakote ER (Divalproex Sodium) Extended-Release Tablets, 500 mg manufactured by Abbott Laboratories. The approval of which appears on page 3-128 of the Aooroved Druo Products with Therapeutic Equivalence Evaluations 23ti edition (See Attachment 1). The petitioner, therefore, seeks a change in strength from that of the reference-listed drug (RLD) product (i.e., a change in strength from 500 mg to 1000 mg tablets). The drug, the route of administration and the recommendations for use are the same as the listed drug product. The proposed product would differ only in dosage strength from Abbott’s currently marketed drug product.