FDA — authorised 6 August 1998
- Application: ANDA075219
- Marketing authorisation holder: TEVA
- Local brand name: DICLOFENAC POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Deflox® in United States
FDA authorised Deflox® on 6 August 1998
Marketing authorisations
FDA — authorised 20 November 1998
- Application: ANDA075229
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: DICLOFENAC POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 1998
- Application: ANDA075152
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: DICLOFENAC POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 July 1999
- Application: ANDA075463
- Marketing authorisation holder: RK PHARMA
- Local brand name: DICLOFENAC POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 February 2001
- Application: ANDA075582
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: DICLOFENAC POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 February 2002
- Application: ANDA075470
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DICLOFENAC POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 May 2016
- Application: ANDA202964
- Marketing authorisation holder: PH HEALTH
- Local brand name: DICLOFENAC POTASSIUM
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 3 December 2019
- Application: ANDA210078
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: DICLOFENAC POTASSIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 October 2021
- Application: ANDA215585
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: DICLOFENAC POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 October 2021
- Application: ANDA213875
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DICLOFENAC POTASSIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 May 2022
- Application: ANDA215750
- Marketing authorisation holder: UMEDICA
- Local brand name: DICLOFENAC POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 August 2025
- Application: ANDA217010
- Marketing authorisation holder: UMEDICA
- Local brand name: DICLOFENAC POTASSIUM
- Indication: FOR SOLUTION — ORAL
- Status: approved
Frequently asked questions
Is Deflox® approved in United States?
Yes. FDA authorised it on 6 August 1998; FDA authorised it on 20 November 1998; FDA authorised it on 27 November 1998.
Who is the marketing authorisation holder for Deflox® in United States?
TEVA holds the US marketing authorisation.