🇺🇸 NITROFURANTOIN MACROCRYSTALS in United States

FDA authorised NITROFURANTOIN MACROCRYSTALS on 28 January 1993

Marketing authorisations

FDA — authorised 28 January 1993

  • Application: ANDA073652
  • Marketing authorisation holder: IMPAX LABS INC
  • Status: supplemented

FDA — authorised 9 July 1997

  • Application: ANDA074967
  • Marketing authorisation holder: AUROBINDO PHARMA USA
  • Status: supplemented

FDA — authorised 18 August 2004

  • Application: ANDA077025
  • Marketing authorisation holder: AUROBINDO PHARMA USA
  • Status: supplemented

FDA — authorised 12 December 2017

  • Application: ANDA205005
  • Marketing authorisation holder: ZYDUS PHARMS
  • Status: approved

FDA — authorised 21 March 2023

  • Application: ANDA217272
  • Marketing authorisation holder: MANKIND PHARMA
  • Status: supplemented

FDA

  • Status: approved

NITROFURANTOIN MACROCRYSTALS 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 NITROFURANTOIN MACROCRYSTALS approved in United States?

Yes. FDA authorised it on 28 January 1993; FDA authorised it on 9 July 1997; FDA authorised it on 18 August 2004.

Who is the marketing authorisation holder for NITROFURANTOIN MACROCRYSTALS in United States?

IMPAX LABS INC holds the US marketing authorisation.