FDA — authorised 15 August 1958
- Application: NDA011529
- Marketing authorisation holder: JANSSEN R AND D
- Local brand name: PARAFON FORTE DSC
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Parafon Forte Dsc in United States
FDA authorised Parafon Forte Dsc on 15 August 1958
Marketing authorisations
FDA — authorised 15 August 1958
- Marketing authorisation holder: JANSSEN R AND D
- Status: approved
FDA — authorised 6 October 1981
- Application: ANDA086901
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 September 1983
- Application: ANDA087981
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 May 1987
- Application: ANDA088928
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 May 1988
- Application: ANDA089852
- Marketing authorisation holder: RISING
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 May 1988
- Application: ANDA089853
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 May 1988
- Application: ANDA089859
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 May 1988
- Application: ANDA089895
- Marketing authorisation holder: BARR
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 1988
- Application: ANDA081008
- Marketing authorisation holder: FERNDALE LABS
- Local brand name: STRIFON FORTE DSC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 1989
- Application: ANDA081040
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 1990
- Application: ANDA089970
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 July 1991
- Application: ANDA081019
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 December 1993
- Application: ANDA081298
- Marketing authorisation holder: OHM LABS
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 December 1993
- Application: ANDA081299
- Marketing authorisation holder: OHM LABS
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 September 1995
- Application: ANDA040113
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 August 1996
- Application: ANDA040137
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 June 2010
- Application: ANDA040861
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 June 2016
- Application: ANDA207483
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 September 2019
- Application: ANDA212254
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 2019
- Application: ANDA212253
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 May 2020
- Application: ANDA212185
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 June 2020
- Application: ANDA212898
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 July 2020
- Application: ANDA211849
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 September 2020
- Application: ANDA212053
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 November 2020
- Application: ANDA212743
- Marketing authorisation holder: PH HEALTH
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 July 2021
- Application: ANDA215158
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 April 2022
- Application: ANDA213126
- Marketing authorisation holder: RISING
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 October 2022
- Application: ANDA214941
- Marketing authorisation holder: COREPHARMA
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2023
- Application: ANDA212047
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 April 2023
- Application: ANDA214702
- Marketing authorisation holder: COREPHARMA
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 April 2023
- Application: ANDA214365
- Marketing authorisation holder: ACME LABS
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 August 2023
- Application: ANDA216925
- Marketing authorisation holder: RISING
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 2024
- Application: ANDA210961
- Marketing authorisation holder: SENORES PHARMS
- Status: approved
FDA
- Application: ANDA089592
- Marketing authorisation holder: PIONEER PHARMS
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089948
- Marketing authorisation holder: PIONEER PHARMS
- Local brand name: CHLORZOXAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA011300
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: PARAFLEX
- Indication: TABLET — ORAL
- Status: approved
Parafon Forte Dsc in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Parafon Forte Dsc approved in United States?
Yes. FDA authorised it on 15 August 1958; FDA authorised it on 15 August 1958; FDA authorised it on 6 October 1981.
Who is the marketing authorisation holder for Parafon Forte Dsc in United States?
JANSSEN R AND D holds the US marketing authorisation.