Regulatory UpdatesSep 2, 2026•1 min read

FDA Approves Methylphenidate Hydrochloride Oral Solution (ANDA 207417)

By the PharmaCountry team

FDA has approved ANDA 207417 for methylphenidate hydrochloride oral solution, 5 mg/5 mL and 10 mg/5 mL strengths, manufactured by Ascent Pharmaceuticals.

The U.S. Food and Drug Administration (FDA) has granted approval for Abbreviated New Drug Application (ANDA) 207417 covering methylphenidate hydrochloride oral solution. The approved products are manufactured by Ascent Pharmaceuticals, Inc. (listed as sponsor Ascent Pharm Inc) and are available in two strengths: 5 mg/5 mL and 10 mg/5 mL. Both are oral solutions indicated for prescription use. The products carry National Drug Code (NDC) identifiers 43602-177-25, 43602-177-05, 43602-178-25, and 43602-178-05 and are classified as human prescription drugs with central nervous system stimulant activity. The FDA submission record shows an original submission (type ORIG) approved on 2021‑01‑29 and a labeling supplement approved on 2025‑06‑06.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#Methylphenidate #ANDA #FDA #oral solution #Ascent Pharmaceuticals #prescription drug