APPLICATION
ANDA074138
TYPE
ANDA
ORIGINAL APPROVAL
1992-09-30
LATEST ACTION
2001-11-28
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
LACTULOSEDiscontinued
LACTULOSE 10GM/15ML · SOLUTION · ORAL
Approval history
2001-11-28Manufacturing (CMC) · Supplement 13AP
2000-03-27Manufacturing (CMC) · Supplement 12AP
1998-02-24Labeling · Supplement 9AP
1997-12-22Manufacturing (CMC) · Supplement 11AP
1997-12-22Manufacturing (CMC) · Supplement 10AP
1997-01-31Labeling · Supplement 8AP
1997-01-31Manufacturing (CMC) · Supplement 7AP
1996-09-20Labeling · Supplement 6AP
1996-08-07Manufacturing (CMC) · Supplement 4AP
1996-08-07Labeling · Supplement 5AP
1996-08-07Manufacturing (CMC) · Supplement 3AP
1994-02-22Manufacturing (CMC) · Supplement 1AP
1992-09-30OriginalAP
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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