🇺🇸 CHLOROQUINE PHOSPHATE in United States

FDA authorised CHLOROQUINE PHOSPHATE on 11 December 1974

Marketing authorisations

FDA — authorised 11 December 1974

  • Application: ANDA080880
  • Marketing authorisation holder: IMPAX LABS
  • Indication: Labeling
  • Status: approved

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FDA — authorised 13 January 1982

  • Application: ANDA087504
  • Marketing authorisation holder: TEVA
  • Local brand name: CHLOROQUINE PHOSPHATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 21 December 1982

  • Application: ANDA088030
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: CHLOROQUINE PHOSPHATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 21 December 1982

  • Application: ANDA087979
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: CHLOROQUINE PHOSPHATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 29 August 2003

  • Application: ANDA040516
  • Marketing authorisation holder: IMPAX LABS
  • Local brand name: CHLOROQUINE PHOSPHATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 3 December 2009

  • Application: ANDA090249
  • Marketing authorisation holder: IPCA LABS LTD
  • Local brand name: CHLOROQUINE PHOSPHATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 21 January 2011

  • Application: ANDA091621
  • Marketing authorisation holder: NATCO PHARMA LTD
  • Status: approved

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FDA — authorised 21 January 2011

  • Application: ANDA090612
  • Marketing authorisation holder: NATCO PHARMA LTD
  • Indication: Labeling
  • Status: approved

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FDA — authorised 3 September 2021

  • Application: ANDA214756
  • Marketing authorisation holder: SUVEN PHARMS
  • Indication: Manufacturing (CMC)
  • Status: approved

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FDA

  • Application: ANDA087228
  • Marketing authorisation holder: MD PHARM
  • Local brand name: CHLOROQUINE PHOSPHATE
  • Indication: TABLET — ORAL
  • Status: approved

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CHLOROQUINE PHOSPHATE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is CHLOROQUINE PHOSPHATE approved in United States?

Yes. FDA authorised it on 11 December 1974; FDA authorised it on 13 January 1982; FDA authorised it on 21 December 1982.

Who is the marketing authorisation holder for CHLOROQUINE PHOSPHATE in United States?

IMPAX LABS holds the US marketing authorisation.