Naproxen Sodium

ANDA 74106, held by Hamilton Pharms. Naproxen Sodium.

As of Nov 15, 2026, ANDA 74106 (Naproxen Sodium), held by Hamilton Pharms, was first approved by FDA on Aug 31, 1993, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 31, 1993
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Aug 31, 1993	Original application	Approved	None posted

Products

2 strengths and forms


Naproxen SodiumEQ 250MG BASE · tablet;oral	Naproxen Sodium	Discontinued
Naproxen SodiumEQ 500MG BASE · tablet;oral	Naproxen Sodium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Dec 28, 1995	Supplement 1Labeling	Approved	None posted
Aug 31, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 74106
Drugs@FDA: Overview at FDA
Company: Hamilton Pharmaceuticals

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