Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Teva’s Methylphenidate Extended‑Release Capsules (ANDA 078873)
The FDA approved ANDA 078873 for Teva’s methylphenidate hydrochloride extended‑release capsules (40 mg, 50 mg, 60 mg). All listed products are currently discontinued.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves Teva Methylphenidate Hydrochloride ER Capsules (ANDA 077707)
FDA has approved Teva Pharm’s methylphenidate hydrochloride extended‑release capsules in 10 mg, 20 mg and 30 mg strengths under ANDA 077707.
Regulatory Updates
Sep 2, 2026•1 min read
FDA Approves Methylphenidate Hydrochloride Oral Solution (ANDA 207417)
FDA has approved ANDA 207417 for methylphenidate hydrochloride oral solution, 5 mg/5 mL and 10 mg/5 mL strengths, manufactured by Ascent Pharmaceuticals.