APPLICATION
ANDA074602
TYPE
ANDA
ORIGINAL APPROVAL
1996-11-14
LATEST ACTION
2001-01-04
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LACTULOSEPrescription
LACTULOSE 10GM/15ML · SOLUTION · ORAL
Approval history
2001-01-04Labeling · Supplement 3AP
1999-07-15Labeling · Supplement 2AP
1999-03-12Manufacturing (CMC) · Supplement 1AP
1996-11-14OriginalAP
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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