Solaraze

NDA 21005, held by Fougera. Diclofenac Sodium.

As of Nov 13, 2026, NDA 21005 (Solaraze), held by Fougera, was first approved by FDA on Oct 16, 2000, with 17 approved supplements and 0 published complete response letters.

First approved: Oct 16, 2000
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Oct 16, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Solaraze3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · gel;topical	Diclofenac Sodium	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 21, 2024	Supplement 25Labeling · Standard review	Approved	Label Letter
Nov 14, 2022	Supplement 24Labeling · Standard review	Approved	Label Medication Guide Letter
Apr 5, 2022	Supplement 23Labeling · Standard review	Approved	Label Label
Apr 28, 2021	Supplement 22Labeling · Standard review	Approved	Label Letter
May 16, 2016	Supplement 17Manufacturing · Standard review	Approved	None posted
May 9, 2016	Supplement 16Labeling · Standard review	Approved	Letter Label
Mar 30, 2015	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 8, 2011	Supplement 13Labeling	Approved	Label Letter
Jun 1, 2007	Supplement 10Manufacturing · Standard review	Approved	Letter
Jul 23, 2004	Supplement 9Manufacturing · Standard review	Approved	Letter
Mar 18, 2004	Supplement 7Manufacturing · Standard review	Approved	Letter
Apr 29, 2003	Supplement 6Labeling · Standard review	Approved	Letter Label
Dec 13, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
May 20, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 19, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 2, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 17, 2001	Supplement 1Labeling · Standard review	Approved	None posted
Oct 16, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21005
Drugs@FDA: Overview at FDA
Company: Fougera

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters