Regulatory UpdatesSep 27, 2026•1 min read

FDA Approves Multiple Risperidone Tablet Strengths Under ANDA 078871

By the PharmaCountry team

FDA has approved six oral tablet strengths of risperidone (0.25 mg to 4 mg) as prescription products, with labeling updates from 2008 to 2023.

The FDA has granted approval for a series of oral tablet products containing the antipsychotic risperidone under ANDA 078871. All six strengths (0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg) are listed as prescription‑only and are not designated as reference drugs. The approval history includes an original submission (ORIG) accepted on 2008‑10‑09, followed by multiple supplemental labeling submissions (SUPPL) approved on 2011‑04‑08, 2011‑06‑20, 2019‑11‑12 (two submissions), and most recently on 2023‑06‑29. Each supplemental filing pertained to labeling updates. The FDA’s documentation also references an additional post‑market safety information link (ID 23925) dated 2008‑11‑25.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#Risperidone #FDA #ANDA #tablet #labeling