Anaprox, Anaprox Ds

NDA 18164, held by Atnahs Pharma US. Naproxen Sodium.

As of Nov 14, 2026, NDA 18164 (Anaprox, Anaprox Ds), held by Atnahs Pharma US, was first approved by FDA on Sep 4, 1980, with 50 approved supplements and 0 published complete response letters.

First approved: Sep 4, 1980
Review: Standard
Supplements approved: 50
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 51 submissions below


Sep 30, 1987	Supplement 36Efficacy (new indication or use)	Approved	None posted
Sep 30, 1987	Supplement 35Efficacy (new indication or use)	Approved	None posted
Sep 4, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


AnaproxEQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Naproxen Sodium	DiscontinuedReference drug
Anaprox DsEQ 500MG BASE · tablet;oral	Naproxen Sodium	RxReference drug

All 51 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 67Labeling · Standard review	Approved	Letter Label Medication Guide
May 13, 2024	Supplement 66Labeling · Standard review	Approved	Label Letter
Apr 28, 2021	Supplement 65Labeling · Standard review	Approved	Label Letter
Jul 22, 2019	Supplement 64Labeling · Standard review	Approved	Letter Label
Mar 10, 2017	Supplement 63Labeling · Standard review	Approved	Letter Label
May 9, 2016	Supplement 62Labeling · Standard review	Approved	Label Letter
Mar 22, 2013	Supplement 61Labeling · Standard review	Approved	Label Letter
Jul 25, 2008	Supplement 60Labeling · Standard review	Approved	Letter Label
Sep 20, 2007	Supplement 58Labeling · Standard review	Approved	Label Letter
Apr 19, 2007	Supplement 57Labeling · Standard review	Approved	Letter
Mar 10, 2006	Supplement 55Labeling · Standard review	Approved	Letter Label
Jan 24, 2006	Supplement 56Labeling · Standard review	Approved	Letter Label
Nov 10, 2004	Supplement 51Labeling · Standard review	Approved	Letter Label
Nov 10, 2004	Supplement 50Labeling · Standard review	Approved	Letter Label
Apr 14, 2003	Supplement 49Labeling · Standard review	Approved	Letter
Feb 22, 2002	Supplement 54Manufacturing · Standard review	Approved	None posted
Nov 9, 2001	Supplement 53Manufacturing · Standard review	Approved	None posted
Dec 8, 2000	Supplement 52Manufacturing · Standard review	Approved	None posted
Feb 8, 1995	Supplement 47Manufacturing · Standard review	Approved	None posted
Sep 6, 1994	Supplement 48Manufacturing · Standard review	Approved	None posted
Dec 15, 1993	Supplement 46Labeling · Standard review	Approved	None posted
Aug 12, 1992	Supplement 45Manufacturing · Standard review	Approved	None posted
May 8, 1992	Supplement 43Manufacturing · Standard review	Approved	None posted
Oct 2, 1990	Supplement 42Manufacturing · Standard review	Approved	None posted
Sep 30, 1987	Supplement 36Efficacy (new indication or use)	Approved	None posted
Sep 30, 1987	Supplement 15Labeling	Approved	None posted
Sep 30, 1987	Supplement 26Manufacturing · Standard review	Approved	None posted
Sep 30, 1987	Supplement 34Labeling	Approved	None posted
Sep 30, 1987	Supplement 35Efficacy (new indication or use)	Approved	None posted
Aug 29, 1986	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 10, 1986	Supplement 33Manufacturing · Standard review	Approved	None posted
Sep 24, 1985	Supplement 31Labeling	Approved	None posted
May 3, 1985	Supplement 28Manufacturing · Standard review	Approved	None posted
Apr 29, 1985	Supplement 25Manufacturing · Standard review	Approved	None posted
Apr 23, 1985	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 9, 1983	Supplement 12Labeling	Approved	None posted
Sep 9, 1983	Supplement 21Labeling	Approved	None posted
Feb 22, 1983	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 7, 1982	Supplement 16Labeling	Approved	None posted
Dec 7, 1982	Supplement 17Labeling	Approved	None posted
Oct 18, 1982	Supplement 13Manufacturing · Standard review	Approved	None posted
May 10, 1982	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 22, 1982	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 22, 1982	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 22, 1982	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 7, 1982	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 7, 1982	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 13, 1981	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 13, 1981	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 13, 1981	Supplement 1Labeling	Approved	None posted
Sep 4, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Show all 51

Identifiers

Application: NDA 18164
Drugs@FDA: Overview at FDA
Company: Atnahs Pharma US

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