FDA — authorised 8 March 1996
- Application: NDA020254
- Marketing authorisation holder: NOVARTIS
- Local brand name: VOLTAREN-XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Diclofenac sodium gel 3% in United States
FDA authorised Diclofenac sodium gel 3% on 8 March 1996
Marketing authorisations
FDA — authorised 26 March 1996
- Application: ANDA074514
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 4 May 1998
- Application: NDA020809
- Marketing authorisation holder: FALCON PHARMS
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 13 November 1998
- Application: ANDA075185
- Marketing authorisation holder: CARLSBAD
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 26 February 1999
- Application: ANDA074986
- Marketing authorisation holder: MICRO LABS
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 16 October 2000
- Application: NDA021005
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: SOLARAZE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 13 December 2001
- Application: ANDA076152
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 February 2002
- Application: ANDA075281
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 6 November 2002
- Application: ANDA076201
- Marketing authorisation holder: DEXCEL LTD
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 October 2007
- Application: NDA022122
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: VOLTAREN ARTHRITIS PAIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 28 December 2007
- Application: ANDA078553
- Marketing authorisation holder: RISING
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 6 February 2008
- Application: ANDA078031
- Marketing authorisation holder: SANDOZ
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 9 May 2013
- Application: ANDA200158
- Marketing authorisation holder: SANDOZ
- Local brand name: DICLOFENAC SODIUM AND MISOPROSTOL
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 28 October 2013
- Application: ANDA200936
- Marketing authorisation holder: AMNEAL
- Local brand name: DICLOFENAC SODIUM
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 9 December 2015
- Application: ANDA205878
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 28 April 2016
- Application: ANDA206298
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: DICLOFENAC SODIUM
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 13 September 2016
- Application: ANDA208301
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: DICLOFENAC SODIUM
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 25 November 2016
- Application: ANDA203995
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: DICLOFENAC SODIUM AND MISOPROSTOL
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 7 August 2017
- Application: ANDA206715
- Marketing authorisation holder: RISING
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 17 April 2018
- Application: ANDA206411
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 27 January 2020
- Application: ANDA210986
- Marketing authorisation holder: ENCUBE
- Local brand name: DICLOFENAC SODIUM
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 19 February 2020
- Application: ANDA205143
- Marketing authorisation holder: YUNG SHIN PHARM
- Local brand name: DICLOFENAC SODIUM AND MISOPROSTOL
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 28 January 2021
- Application: ANDA206655
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 15 July 2021
- Application: ANDA204355
- Marketing authorisation holder: MICRO LABS
- Local brand name: DICLOFENAC SODIUM AND MISOPROSTOL
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 18 August 2022
- Application: ANDA208198
- Marketing authorisation holder: AMNEAL
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 21 September 2022
- Application: ANDA208021
- Marketing authorisation holder: LUPIN PHARMS
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 29 November 2022
- Application: ANDA212506
- Marketing authorisation holder: ALEMBIC
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 11 May 2023
- Application: ANDA216548
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 12 June 2023
- Application: ANDA206771
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: DICLOFENAC SODIUM AND MISOPROSTOL
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 5 November 2025
- Application: ANDA219945
- Marketing authorisation holder: UMEDICA
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
The FDA approved Umedica's Diclofenac sodium gel 3% for marketing in the United States on 5 November 2025. The approval was granted under the standard expedited pathway. The product is indicated for the treatment of pain, but the approved indication is for a delayed release oral tablet, not the topical gel. The marketing authorisation holder is Umedica, and the local brand name is Diclofenac Sodium.
FDA
- Application: ANDA207238
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — TOPICAL
- Status: approved
Frequently asked questions
Is Diclofenac sodium gel 3% approved in United States?
Yes. FDA authorised it on 8 March 1996; FDA authorised it on 26 March 1996; FDA authorised it on 4 May 1998.
Who is the marketing authorisation holder for Diclofenac sodium gel 3% in United States?
NOVARTIS holds the US marketing authorisation.