APPLICATION
ANDA217914
TYPE
ANDA
ORIGINAL APPROVAL
2025-03-14
LATEST ACTION
2025-03-14
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription
Products
LACTULOSEPrescription
LACTULOSE 10GM/PACKET · FOR SOLUTION · ORAL
LACTULOSEPrescription
LACTULOSE 20GM/PACKET · FOR SOLUTION · ORAL
Approval history
2025-03-14UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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