APPLICATION
ANDA070288
TYPE
ANDA
ORIGINAL APPROVAL
1988-08-15
LATEST ACTION
1997-12-16
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
CONSTULOSEDiscontinued
LACTULOSE 10GM/15ML · SOLUTION · ORAL
Approval history
1997-12-16Manufacturing (CMC) · Supplement 24AP
1996-08-26Manufacturing (CMC) · Supplement 23AP
1996-01-17Manufacturing (CMC) · Supplement 22AP
1994-09-09Manufacturing (CMC) · Supplement 21AP
1993-08-03Manufacturing (CMC) · Supplement 19AP
1993-06-04Manufacturing (CMC) · Supplement 18AP
1993-06-04Manufacturing (CMC) · Supplement 20AP
1993-02-11Manufacturing (CMC) · Supplement 16AP
1992-01-27Manufacturing (CMC) · Supplement 13AP
1991-08-21Labeling · Supplement 42AP
1991-08-21Labeling · Supplement 9AP
1991-07-24Manufacturing (CMC) · Supplement 17AP
1991-02-21Labeling · Supplement 15AP
1990-09-28Manufacturing (CMC) · Supplement 14AP
1990-07-31Labeling · Supplement 12AP
1988-08-19Labeling · Supplement 1AP
1988-08-15OriginalAP
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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