FDA Approves ANDA208756 for Dexmethylphenidate Tablets (Rhodes Pharm)

The U.S. Food and Drug Administration (FDA) issued an approval for application number ANDA208756 on November 20, 2017. The submission was an original (ORIG) filing submitted by Rhodes Pharm and received a standard review priority. The approved ANDA covers three oral tablet products containing dexmethylphenidate hydrochloride at strengths of 2.5 mg, 5 mg, and 10 mg. All three products are classified as tablets for oral administration and are identified with product numbers 001, 002, and 003 respectively. Each listed product is marked with a marketing status of “Discontinued,” indicating that while the ANDA has been approved, the specific tablet formulations are not currently marketed. No reference drug status or reference standard is indicated for these products.