FDA — authorised 29 June 1995
- Application: ANDA074391
- Marketing authorisation holder: ROXANE
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 Arthrotec in United States
FDA authorised Arthrotec on 29 June 1995
Marketing authorisations
FDA — authorised 28 September 1995
- Application: ANDA074376
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 30 November 1995
- Application: ANDA074394
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 8 March 1996
- Application: NDA020254
- Marketing authorisation holder: NOVARTIS
- Local brand name: VOLTAREN-XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
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 15 August 1996
- Application: ANDA074390
- Marketing authorisation holder: TEVA
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 24 December 1997
- Application: NDA020607
- Marketing authorisation holder: PFIZER
- Local brand name: ARTHROTEC
- 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 30 March 1999
- Application: ANDA074723
- Marketing authorisation holder: TEVA
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 29 July 1999
- Application: ANDA074432
- Marketing authorisation holder: PLIVA
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 11 February 2000
- Application: ANDA075492
- Marketing authorisation holder: VPNA
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- 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 7 January 2002
- Application: ANDA075910
- Marketing authorisation holder: ACTAVIS ELIZABETH
- 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 8 June 2007
- Application: ANDA077863
- Marketing authorisation holder: UNIQUE
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, DELAYED 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 17 April 2008
- Application: ANDA077845
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 4 November 2009
- Application: NDA020947
- Marketing authorisation holder: NUVO PHARMS INC
- Local brand name: PENNSAID
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 9 July 2012
- Application: ANDA201089
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: DICLOFENAC SODIUM AND MISOPROSTOL
- Indication: TABLET, DELAYED RELEASE — ORAL
- 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 16 January 2014
- Application: NDA204623
- Marketing authorisation holder: HORIZON
- Local brand name: PENNSAID
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 27 May 2014
- Application: ANDA202027
- Marketing authorisation holder: APOTEX
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 24 November 2014
- Application: ANDA202852
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 26 November 2014
- Application: ANDA203818
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 20 August 2015
- Application: ANDA204132
- Marketing authorisation holder: LUPIN
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 16 November 2015
- Application: ANDA203383
- Marketing authorisation holder: ALTAIRE PHARMS INC
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 2 December 2015
- Application: ANDA206493
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: DICLOFENAC SODIUM
- Indication: GEL — TOPICAL
- Status: approved
The FDA approved Arthrotec, a drug product, for labeling indication on November 14, 2024. The marketing authorization holder is ACTAVIS MID ATLANTIC. The approval was granted under the standard expedited pathway.
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 18 March 2016
- Application: ANDA208077
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: DICLOFENAC SODIUM
- Indication: GEL — 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 2 September 2016
- Application: ANDA206116
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — 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 July 2018
- Application: ANDA210893
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: DICLOFENAC SODIUM
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 3 August 2018
- Application: ANDA209903
- Marketing authorisation holder: CIPLA
- Local brand name: DICLOFENAC SODIUM
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 21 November 2018
- Application: ANDA209484
- Marketing authorisation holder: HIKMA
- Local brand name: DICLOFENAC SODIUM
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 16 May 2019
- Application: ANDA211253
- Marketing authorisation holder: PERRIGO PHARMA INTL
- Local brand name: DICLOFENAC SODIUM
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 18 June 2019
- Application: ANDA208786
- Marketing authorisation holder: RISING
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — INTRAVENOUS
- 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 6 May 2022
- Application: ANDA207714
- Marketing authorisation holder: APOTEX
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — TOPICAL
- 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 23 September 2022
- Application: ANDA216275
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: DICLOFENAC SODIUM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 September 2022
- Application: ANDA208098
- Marketing authorisation holder: SUN PHARMA CANADA
- 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
FDA
- Application: ANDA203786
- Marketing authorisation holder: VERSAPHARM INC
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA
- Application: ANDA208068
- Marketing authorisation holder: PADDOCK LABS
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA
- Application: ANDA207238
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: DICLOFENAC SODIUM
- Indication: SOLUTION — TOPICAL
- Status: approved
Arthrotec in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Arthrotec approved in United States?
Yes. FDA authorised it on 29 June 1995; FDA authorised it on 28 September 1995; FDA authorised it on 30 November 1995.
Who is the marketing authorisation holder for Arthrotec in United States?
ROXANE holds the US marketing authorisation.