Diclofenac Sodium

Sold as Voltaren, Voltaren-Xr, Diclofenac Sodium, Pennsaid, Solaraze and 3 more. Every FDA application for this active ingredient: 10 branded and 60 generic.

As of Nov 15, 2026, FDA lists 70 applications for Diclofenac Sodium (sold as Voltaren, Voltaren-Xr, Diclofenac Sodium and others), first approved Jul 28, 1988, with 3 new uses approved and 0 published complete response letters.

First approved: Jul 28, 1988
Applications: 70
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $224M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Diclofenac Sodium	Part D	$212M	-38%	1,298,210
Diclofenac Sodium ER	Part D	$11.6M	+6%	60,774
Pennsaid	Part D	$532K	-82%	76

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

DICLOFENAC 0.1% EYE DROPS: $1.71 per MLGeneric · -13% in a year
DICLOFENAC 1.5% TOPICAL SOLN: $0.125 per MLGeneric · -31% in a year
DICLOFENAC 2% SOLUTION PUMP: $0.387 per GMGeneric · -31% in a year
DICLOFENAC POTASSIUM 25 MG CAP: $2.96 per unitGeneric · +22% in a year
DICLOFENAC SODIUM 3% GEL: $0.353 per GMGeneric · -9% in a year

FDA Drug Safety Communications

One communication since 2020 that name this drug; see all communications

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluidOct 15, 2020

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Zicthoru TapesA drug with a new indication and a new dosage for the analgesia and anti-inflammation in patients with lumbago, periarthritis scapulohumeralis,… · Hisamitsu Pharmaceutical Co., Inc. · Jun 20, 2022
Zicthoru Tapes, new approvalA drug with a new indication in a new dosage form for analgesia in various types of cancer. · Hisamitsu Pharmaceutical Co., Inc. · Mar 23, 2021

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Diclofenac Sodium Tablet, Delayed Release	To Be Discontinued	Aug 13, 2026	Aug 13, 2026

Clinical Trials

68 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University HospitalCesarean Section · Assiut University	Phase 4	Active, not recruiting	Nov 6, 2026
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary MolarsPulpitis · Suez Canal University	Phase 3	Not yet recruiting	Nov 5, 2026
A Phase III Trial to Evaluate the Safety and Efficacy of Anti-inflammatory Drugs in Addition to Praziquantel in Girls and Women With Female Genital SchistosomiasisFemale Genital Schistosomiasis · Brian Ngwira	Phase 3	Not yet recruiting	Nov 4, 2026
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)Post ERCP Pancreatitis, Acute Pancreatitis (AP) · University Hospital Virgen de las Nieves	Not applicable	Not yet recruiting	Oct 21, 2026
Topical Dexamethasone/Diclofenac Hydrogel for Postoperative Pain and Swelling in Facial Soft Tissue InjuriesFacial Injuries, Pain · Thamar University	Phase 2 / Phase 3	Recruiting	Oct 2, 2026
COMPARISON OF THE EFFECTS OF ERECTOR SPINAE PLANE (ESP) BLOCK AND QUADRO İLİAC PLANE (QIP) BLOCK ON POSTOPERATIVE OPIOID CONSUMPTION AND PAIN IN LUMBAR SPINAL SURGERYPostoperative Pain Management · Aydin Adnan Menderes University	Not applicable	Not yet recruiting	Oct 1, 2026
Medication vs. Meditation for Chronic Knee OsteoarthritisKnee Osteoarthristis · Florida State University	Early phase 1	Not yet recruiting	Sep 23, 2026
Tacrolimus as Prophylaxis of Post-ERCP PancreatitisPost-ERCP Pancreatitis · Amsterdam UMC, location VUmc	Phase 4	Recruiting	Aug 24, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jul 28, 1988	VoltarenNDA 19201 · New molecular entity	Novartis	37	Discontinued
Mar 28, 1991	VoltarenNDA 20037 · New dosage form	Novartis	17	Discontinued
Jun 29, 1995	Diclofenac SodiumANDA 74391	Roxane	12	Discontinued
Sep 28, 1995	Diclofenac SodiumANDA 74376	Chartwell Rx	24	Discontinued
Nov 30, 1995	Diclofenac SodiumANDA 74394	Chartwell Rx	26	Discontinued
Mar 8, 1996	Voltaren-XrNDA 20254 · New dosage form	Novartis	22	Discontinued
Mar 26, 1996	Diclofenac SodiumANDA 74514	Actavis Elizabeth	18	Marketed
Aug 15, 1996	Diclofenac SodiumANDA 74390	Teva	0	Discontinued
Jun 25, 1997	Diclofenac SodiumANDA 74459	Teva Pharms	1	Discontinued
May 4, 1998	Diclofenac SodiumNDA 20809 · New dosage form	Falcon Pharms	8	Discontinued
Nov 13, 1998	Diclofenac SodiumANDA 75185	Carlsbad	9	Marketed
Feb 26, 1999	Diclofenac SodiumANDA 74986	Micro Labs	3	Discontinued
Mar 30, 1999	Diclofenac SodiumANDA 74723	Teva	1	Discontinued
Jul 29, 1999	Diclofenac SodiumANDA 74432	Pliva	6	Discontinued
Feb 11, 2000	Diclofenac SodiumANDA 75492	Vpna	8	Marketed
Oct 16, 2000	SolarazeNDA 21005 · New dosage form	Fougera	17	Discontinued
Dec 13, 2001	Diclofenac SodiumANDA 76152	Aurobindo Pharma USA	10	Marketed
Jan 7, 2002	Diclofenac SodiumANDA 75910	Actavis Elizabeth	8	Discontinued
Feb 12, 2002	Diclofenac SodiumANDA 75281	Aurobindo Pharma USA	8	Marketed
Nov 6, 2002	Diclofenac SodiumANDA 76201	Dexcel Ltd	9	Marketed
Jun 8, 2007	Diclofenac SodiumANDA 77863	Unique	8	Marketed
Oct 17, 2007	Voltaren Arthritis PainNDA 22122 · New dosage form	Haleon US Holdings	16	Marketed
Dec 28, 2007	Diclofenac SodiumANDA 78553	Rising	0	Marketed
Dec 28, 2007	Diclofenac SodiumANDA 78792	Bausch And Lomb	1	Marketed
Feb 6, 2008	Diclofenac SodiumANDA 78031	Sandoz	0	Marketed
Apr 17, 2008	Diclofenac SodiumANDA 77845	Sciegen Pharms	0	Discontinued
Nov 13, 2008	Diclofenac SodiumANDA 77600	Rubicon Research	1	Marketed
Nov 4, 2009	PennsaidNDA 20947 · New dosage form	Nuvo Pharms Inc	6	Discontinued
Dec 1, 2010	Diclofenac SodiumANDA 90066	Unique	7	Marketed
Oct 28, 2013	Diclofenac SodiumANDA 200936	Amneal	4	Discontinued
Jan 16, 2014	PennsaidNDA 204623 · New dosage form	Horizon	11	Discontinued
May 27, 2014	Diclofenac SodiumANDA 202027	Apotex	4	Discontinued
Nov 24, 2014	Diclofenac SodiumANDA 202393	Twi Pharms	2	Discontinued
Nov 24, 2014	Diclofenac SodiumANDA 202852	Watson Labs Inc	3	Marketed
Nov 26, 2014	Diclofenac SodiumANDA 203818	Sun Pharma Canada	3	Marketed
Dec 23, 2014	DylojectNDA 22396 · New dosage form	Javelin Pharms Inc	3	Discontinued
Jul 8, 2015	Diclofenac SodiumANDA 202769	Pai Holdings Pharm	5	Discontinued
Aug 20, 2015	Diclofenac SodiumANDA 204132	Lupin	4	Marketed
Nov 16, 2015	Diclofenac SodiumANDA 203383	Altaire Pharms Inc	0	Marketed
Dec 2, 2015	Diclofenac SodiumANDA 206493	Actavis Mid Atlantic	5	Marketed
Dec 9, 2015	Diclofenac SodiumANDA 205878	Novel Labs Inc	3	Marketed
Mar 18, 2016	Diclofenac SodiumANDA 208077	Amneal Pharms	1	Marketed
Apr 28, 2016	Diclofenac SodiumANDA 206298	Sun Pharma Canada	4	Marketed
Sep 2, 2016	Diclofenac SodiumANDA 206116	Amneal Pharms	2	Marketed
Sep 13, 2016	Diclofenac SodiumANDA 208301	Glenmark Pharms Ltd	4	Marketed
Aug 7, 2017	Diclofenac SodiumANDA 206715	Rising	2	Discontinued
Apr 17, 2018	Diclofenac SodiumANDA 206411	Zydus Lifesciences	2	Marketed
Jul 27, 2018	Diclofenac SodiumANDA 210893	Padagis Israel	3	Marketed
Aug 3, 2018	Diclofenac SodiumANDA 209903	Cipla	1	Marketed
Nov 21, 2018	Diclofenac SodiumANDA 209484	Hikma	1	Discontinued
May 6, 2019	Diclofenac SodiumANDA 204306	Aurolife Pharma LLC	2	Marketed
May 16, 2019	Diclofenac SodiumANDA 211253	Perrigo Pharma Intl	5	Marketed
Jun 18, 2019	Diclofenac SodiumANDA 208786	Rising	2	Discontinued
Jan 27, 2020	Diclofenac SodiumANDA 210986	Encube	3	Marketed
Jan 28, 2021	Diclofenac SodiumANDA 206655	Epic Pharma LLC	1	Marketed
May 6, 2022	Diclofenac SodiumANDA 207714	Apotex	1	Marketed
Jul 27, 2022	Diclofenac SodiumANDA 212351	Alembic	2	Marketed
Aug 18, 2022	Diclofenac SodiumANDA 208198	Amneal	1	Marketed
Sep 21, 2022	Diclofenac SodiumANDA 208021	Lupin Pharms	1	Marketed
Sep 23, 2022	Diclofenac SodiumANDA 216275	Ingenus Pharms LLC	1	Marketed
Sep 29, 2022	Diclofenac SodiumANDA 208098	Sun Pharma Canada	1	Marketed
Nov 29, 2022	Diclofenac SodiumANDA 212506	Alembic	1	Marketed
Feb 3, 2023	Diclofenac SodiumANDA 213040	Aurolife Pharma LLC	1	Marketed
May 11, 2023	Diclofenac SodiumANDA 216548	Rubicon Research	1	Marketed
Apr 9, 2025	Diclofenac SodiumANDA 217646	Encube	0	Marketed
Nov 5, 2025	Diclofenac SodiumANDA 219945	Umedica	0	Marketed
Sep 25, 2026	ZueinoNDA 218379 · New formulation or manufacturer	Adventapharma	0	Marketed
—	Diclofenac SodiumANDA 203786	Versapharm Inc	0	Discontinued
—	Diclofenac SodiumANDA 207238	Actavis Labs Ut Inc	0	Discontinued
—	Diclofenac SodiumANDA 208068	Paddock Labs	0	Discontinued

Show all 70

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA