General MedicationsORALStandard
LACTULOSE
LACTULOSE
Standard Dose
10GM/15ML
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 218858 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient LACTULOSE Form and strength SOLUTION;ORAL - 10GM/15ML Sponsor TARO Submission history Latest submission status date: 2024-12-13 00:00:00.
Structured Monograph
Clinical summary
Approval overview LACTULOSE is listed in Drugs@FDA under application 218858 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LACTULOSE Form and strength SOLUTION;ORAL - 10GM/15ML Sponsor TARO Submission history Latest submission status date: 2024-12-13 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.