Request that the FDA declare that an ANDA may be submitted for, Haloperidol Tablets USP, 0.25 and 2.5 mg, two strengths that differ from the currently approved RLD, HALDOL (Haloperidol) tablets from ORTHO MCNEIL PHARMACEUTICAL, which FDA approved in 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg strengths prior to Jan 1, 1982 under NDA #015921 | Federal Regulations · Congress.wiki