FDA approves labeling supplement for Actavis's orally disintegrating risperidone tablets
A labeling supplement covering five strengths of Actavis Labs FL's orally disintegrating risperidone tablets was approved on July 1, 2026.
This week's filing activity brought one approval covering an existing generic product line.
- A supplement labeled SUPPL 5, classified as a labeling submission, was approved for ANDA076996, covering Actavis Labs FL's orally disintegrating risperidone tablets in strengths of 0.5MG, 1MG, 2MG, 3MG, and 4MG, with a standard review priority and a submission status date of 2026-07-01.1
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