APPLICATION
ANDA073591
TYPE
ANDA
ORIGINAL APPROVAL
1992-05-29
LATEST ACTION
2008-02-06
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
LACTULOSEDiscontinued
LACTULOSE 10GM/15ML · SOLUTION · ORAL
Approval history
2008-02-06Labeling · Supplement 19AP
2002-10-23Manufacturing (CMC) · Supplement 15AP
2000-11-30Manufacturing (CMC) · Supplement 14AP
2000-03-27Manufacturing (CMC) · Supplement 12AP
1998-09-02Manufacturing (CMC) · Supplement 13AP
1996-12-11Manufacturing (CMC) · Supplement 10AP
1996-12-11Manufacturing (CMC) · Supplement 9AP
1996-09-20Manufacturing (CMC) · Supplement 8AP
1996-09-20Manufacturing (CMC) · Supplement 6AP
1996-09-20Labeling · Supplement 7AP
1996-08-28Manufacturing (CMC) · Supplement 5AP
1995-08-18Manufacturing (CMC) · Supplement 4AP
1995-08-18Labeling · Supplement 2AP
1995-08-18Manufacturing (CMC) · Supplement 1AP
1995-02-08Labeling · Supplement 3AP
1992-05-29OriginalAP
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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