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As of Nov 13, 2026, ANDA 71195 (Lorazepam), held by Sandoz, was first approved by FDA on Apr 15, 1988, with 16 approved supplements and 0 published complete response letters.
First approved: Apr 15, 1988
Supplements approved: 16
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 17 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
