Aleve-D Sinus & Cold

NDA 21076, held by Bayer. Naproxen Sodium; Pseudoephedrine Hydrochloride.

As of Nov 15, 2026, NDA 21076 (Aleve-D Sinus & Cold), held by Bayer, was first approved by FDA on Nov 29, 1999, with 13 approved supplements and 0 published complete response letters.

First approved: Nov 29, 1999
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Nov 29, 1999	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aleve-D Sinus & Cold220MG;120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Naproxen Sodium; Pseudoephedrine Hydrochloride	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


Jul 11, 2023	Supplement 19Labeling · Standard review	Approved	Letter Label
Mar 2, 2022	Supplement 17Labeling · Standard review	Approved	Letter Label
Apr 6, 2020	Supplement 16Labeling · Standard review	Approved	Label Letter
Sep 12, 2017	Supplement 15Labeling · Standard review	Approved	Label Letter
Apr 17, 2009	Supplement 14Labeling · Standard review	Approved	Letter
Aug 4, 2008	Supplement 13Labeling · Standard review	Approved	Letter
Jan 6, 2006	Supplement 11Labeling · Standard review	Approved	Letter
Jul 31, 2002	Supplement 7Labeling · Standard review	Approved	Letter
Dec 21, 2001	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 18, 2001	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 15, 2001	Supplement 3Manufacturing · Standard review	Approved	None posted
May 15, 2000	Supplement 1Labeling · Standard review	Approved	None posted
Apr 26, 2000	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 29, 1999	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21076
Drugs@FDA: Overview at FDA
Company: Bayer

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