Diclofenac Sodium

NDA 20809, held by Falcon Pharms. Diclofenac Sodium.

As of Nov 14, 2026, NDA 20809 (Diclofenac Sodium), held by Falcon Pharms, was first approved by FDA on May 4, 1998, with 8 approved supplements and 0 published complete response letters.

First approved: May 4, 1998
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
May 4, 1998	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diclofenac Sodium0.1% · solution/drops;ophthalmic	Diclofenac Sodium	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Mar 13, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 16, 2001	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 18, 2000	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 17, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 6, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 17, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 5, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 2, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
May 4, 1998	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Identifiers

Application: NDA 20809
Drugs@FDA: Overview at FDA
Company: Falcon Pharmaceuticals

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