FDA Approves Teva Methylphenidate Hydrochloride ER Capsules (ANDA 077707)

The U.S. Food and Drug Administration has granted approval for Teva Pharm’s methylphenidate hydrochloride extended‑release capsules under application number ANDA 077707. The approval covers three oral capsule products, each with a different strength: 10 mg (product number 001), 20 mg (product number 002) and 30 mg (product number 003). All are prescription‑only and are not designated as reference drugs. All three products share the same route (oral) and dosage form (capsule, extended release) and are marketed under the brand name METHYLPHENIDATE HYDROCHLORIDE. The submission record includes an original approval filing (submission type ORIG, submission number 1) with a review document dated 17 Sep 2012 (available at http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/077707Orig1s000Approv.pdf). Subsequent labeling supplements were filed under standard review priority, with submission numbers 1, 3, 4, 5, 8, 13 and 14, the latest dated 6 Oct 2022. The sponsor listed for the application is Teva Pharm.