APPLICATION
ANDA071331
TYPE
ANDA
ORIGINAL APPROVAL
1988-07-26
LATEST ACTION
1999-11-03
ROUTE
ORAL, RECTAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
CHOLACDiscontinued
LACTULOSE 10GM/15ML · SOLUTION · ORAL, RECTAL
Approval history
1999-11-03Manufacturing (CMC) · Supplement 5AP
1999-11-03Manufacturing (CMC) · Supplement 4AP
1995-06-14Manufacturing (CMC) · Supplement 2AP
1995-06-14Manufacturing (CMC) · Supplement 3AP
1990-12-07Labeling · Supplement 1AP
1988-07-26OriginalAP
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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