Request that the FDA declare that Lactulose for Oral Solution, 15 gPacket, is suitable for submission as an ANDA. As designated in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), the Reference Listed Drug (“RLD”) upon which this petition is based is Sanofi Aventis US’s Chronulac (lactulose) oral solution, which was approved for prescription use | Federal Regulations · Congress.wiki