Flector

Treats acute pain due to minor strains, sprains, and contusions. NDA 21234, held by Ibsa. Diclofenac Epolamine.

As of Nov 14, 2026, NDA 21234 (Flector), held by Ibsa, was first approved by FDA on Jan 31, 2007, with 15 approved supplements and 0 published complete response letters.

First approved: Jan 31, 2007
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Mar 1, 2019	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Other
Jan 31, 2007	Original applicationNew active ingredient · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Flector1.3% · system;topical	Diclofenac Epolamine	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 24Labeling · Standard review	Approved	Label Medication Guide Letter
Apr 28, 2021	Supplement 19Labeling · Standard review	Approved	Label Letter
Mar 1, 2019	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Other
Mar 1, 2019	Supplement 17Labeling · Standard review	Approved	Letter Label
Aug 30, 2018	Supplement 15Labeling · Standard review	Approved	Letter Label
May 9, 2016	Supplement 13Labeling · Standard review	Approved	Letter Label
May 9, 2016	Supplement 14Labeling · Standard review	Approved	Letter Label
May 8, 2013	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 23, 2011	Supplement 9Labeling · Standard review	Approved	Label Letter
Jan 31, 2011	Supplement 5Labeling · Standard review	Approved	Letter Label
Jan 31, 2011	Supplement 8Labeling	Approved	Letter
Sep 3, 2009	Supplement 6Labeling	Approved	Letter Label
Sep 3, 2009	Supplement 7Labeling	Approved	Label
Oct 23, 2008	Supplement 4Labeling · Standard review	Approved	Letter
Jun 4, 2008	Supplement 3Labeling · Standard review	Approved	Label Letter
Jan 31, 2007	Original applicationNew active ingredient · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21234
Drugs@FDA: Overview at FDA
Company: IBSA Institut Biochimique SA

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