APPLICATION
ANDA073497
TYPE
ANDA
ORIGINAL APPROVAL
1993-05-28
LATEST ACTION
1999-03-23
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
EVALOSEDiscontinued
LACTULOSE 10GM/15ML · SOLUTION · ORAL
Approval history
1999-03-23Manufacturing (CMC) · Supplement 3AP
1996-05-31Manufacturing (CMC) · Supplement 2AP
1995-06-30Manufacturing (CMC) · Supplement 1AP
1993-05-28OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.