FDA — authorised 18 April 1955
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
🇺🇸 Hydroxychloroquine Sulfate in United States
FDA authorised Hydroxychloroquine Sulfate on 18 April 1955
Marketing authorisations
FDA — authorised 30 September 1994
- Application: ANDA040081
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: HYDROXYCHLOROQUINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 November 1995
- Application: ANDA040104
- Marketing authorisation holder: SANDOZ
- Local brand name: HYDROXYCHLOROQUINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 November 1995
- Application: ANDA040133
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYCHLOROQUINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 1996
- Application: ANDA040150
- Marketing authorisation holder: CREEKWOOD PHARMS
- Local brand name: HYDROXYCHLOROQUINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 May 1998
- Application: ANDA040274
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: HYDROXYCHLOROQUINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 August 2007
- Application: ANDA040760
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: HYDROXYCHLOROQUINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 September 2007
- Application: ANDA040657
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: HYDROXYCHLOROQUINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 May 2018
- Application: ANDA210441
- Marketing authorisation holder: APPCO
- Local brand name: HYDROXYCHLOROQUINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 May 2018
- Application: ANDA201691
- Marketing authorisation holder: ALKALOIDA ZRT
- Local brand name: HYDROXYCHLOROQUINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 May 2018
- Application: ANDA210577
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: HYDROXYCHLOROQUINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 July 2018
- Application: ANDA210543
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: HYDROXYCHLOROQUINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 2020
- Application: ANDA213342
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: HYDROXYCHLOROQUINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2020
- Application: ANDA212902
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: HYDROXYCHLOROQUINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 January 2022
- Application: NDA214581
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: SOVUNA
- Indication: TABLET — ORAL
- Status: approved
Hydroxychloroquine Sulfate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Hydroxychloroquine Sulfate approved in United States?
Yes. FDA authorised it on 18 April 1955; FDA authorised it on 30 September 1994; FDA authorised it on 30 November 1995.
Who is the marketing authorisation holder for Hydroxychloroquine Sulfate in United States?
SANOFI AVENTIS US holds the US marketing authorisation.