APPLICATION
ANDA203762
TYPE
ANDA
ORIGINAL APPROVAL
2015-03-27
LATEST ACTION
2021-08-16
ROUTE
ORAL, RECTAL, ORAL, RECTAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LACTULOSEPrescription
LACTULOSE 10GM/15ML · SOLUTION · ORAL, RECTAL
Approval history
2021-08-16Manufacturing (CMC) · Supplement 4 · unknownAP
2015-03-27UNKNOWN · OriginalAP
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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