FDA Approves Teva’s Methylphenidate Extended‑Release Capsules (ANDA 078873)

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research granted approval for application ANDA 078873 submitted by Teva Pharmaceuticals. The approval covers three oral, extended‑release capsule products containing methylphenidate hydrochloride at strengths of 40 mg, 50 mg, and 60 mg. In the FDA database, each of these products is marked with a marketing status of “Discontinued.” The original approval was issued on July 19 2012, and the review document is available via the FDA’s public archive. Since the original approval, a series of labeling supplement submissions (numbers 1, 3, 4, 6, 9, 13, and 14) have been approved, most recently on October 6 2022. These supplements pertain to labeling updates for the same products. For full details, see the original approval PDF linked in the FDA submission records.