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As of Nov 13, 2026, ANDA 74648 (Lorazepam), held by Roxane, was first approved by FDA on Mar 18, 1997, with 2 approved supplements and 0 published complete response letters.
First approved: Mar 18, 1997
Supplements approved: 2
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 3 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
