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As of Nov 14, 2026, ANDA 74190 (Naproxen), held by Hikma, was first approved by FDA on Mar 30, 1994, with 15 approved supplements and 0 published complete response letters.
First approved: Mar 30, 1994
Supplements approved: 15
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Naproxen oral suspension is indicated for: the relief of the signs and symptoms of:
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
