General MedicationsORALStandard
LACTULOSE
LACTULOSE
Standard Dose
20GM/PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview LACTULOSE is listed in Drugs@FDA under application 217914 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient LACTULOSE Form and strength FOR SOLUTION;ORAL - 20GM/PACKET Sponsor PAI HOLDINGS Submission history Latest submission status date: 2025-03-14 00:00:00.
Structured Monograph
Clinical summary
Approval overview LACTULOSE is listed in Drugs@FDA under application 217914 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LACTULOSE Form and strength FOR SOLUTION;ORAL - 20GM/PACKET Sponsor PAI HOLDINGS Submission history Latest submission status date: 2025-03-14 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.