APPLICATION
ANDA074077
TYPE
ANDA
ORIGINAL APPROVAL
1995-07-03
LATEST ACTION
2009-09-04
ROUTE
ORAL, RECTAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
LACTULOSEDiscontinued
LACTULOSE 10GM/15ML · SOLUTION · ORAL, RECTAL
Approval history
2009-09-04Labeling · Supplement 7AP
2009-05-05Labeling · Supplement 5AP
1997-10-09Manufacturing (CMC) · Supplement 2AP
1997-10-09Manufacturing (CMC) · Supplement 3AP
1997-10-09Manufacturing (CMC) · Supplement 1AP
1995-07-03OriginalAP
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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