Naproxen Sodium

ANDA 74242, held by Pliva. Naproxen Sodium.

As of Nov 15, 2026, ANDA 74242 (Naproxen Sodium), held by Pliva, was first approved by FDA on Jun 20, 1996, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 20, 1996
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
Jun 20, 1996	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


Jul 7, 2000	Supplement 1Manufacturing	Approved	None posted
Jun 20, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74242
Drugs@FDA: Overview at FDA
Company: PLIVA

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