Naproxen Sodium

ANDA 74646, held by Pld Acquisitions LLC. Naproxen Sodium.

As of Nov 15, 2026, ANDA 74646 (Naproxen Sodium), held by Pld Acquisitions LLC, was first approved by FDA on Jan 13, 1997, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 13, 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

Date	Submission	Status	Documents
Jan 13, 1997	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Naproxen Sodium220MG · tablet;oral	Naproxen Sodium	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Feb 22, 2000	Supplement 1Manufacturing	Approved	None posted
Feb 22, 2000	Supplement 2Manufacturing	Approved	None posted
Jan 13, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74646
Drugs@FDA: Overview at FDA
Company: PLD Acquisitions

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