Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Haloperidol Tablets USP in strengths of 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg.

The approved product is therapeutically equivalent to Haldol tablets of Ortho McNeil Pharmaceutical and is indicated for the management of psychotic disorders as well as the control of tics and vocal utterances associated with Tourette’s Disorder in children and adults.

According to IQVIA, the approved dosage strengths of Haloperidol Tablets had an estimated US market size of approximately $27 million for the 12 months ended March 2026.