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As of Nov 13, 2026, ANDA 73591 (Lactulose), held by Hikma, was first approved by FDA on May 29, 1992, with 15 approved supplements and 0 published complete response letters.
First approved: May 29, 1992
Supplements approved: 15
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 16 submissions below
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
