🇺🇸 The "water group" in United States

FDA authorised The "water group" on 30 June 1987

Marketing authorisations

FDA — authorised 30 June 1987

  • Application: NDA019039
  • Marketing authorisation holder: SUN PHARM INDS INC
  • Status: supplemented

FDA — authorised 21 November 2007

  • Application: ANDA040811
  • Marketing authorisation holder: RENEW PHARMS
  • Status: approved

FDA — authorised 7 December 2012

  • Application: NDA204200
  • Marketing authorisation holder: PH HEALTH
  • Status: supplemented

FDA — authorised 2 December 2019

  • Application: ANDA211188
  • Marketing authorisation holder: MEDEFIL INC
  • Status: supplemented

Other Cardiovascular approved in United States

Frequently asked questions

Is The "water group" approved in United States?

Yes. FDA authorised it on 30 June 1987; FDA authorised it on 21 November 2007; FDA authorised it on 7 December 2012.

Who is the marketing authorisation holder for The "water group" in United States?

SUN PHARM INDS INC holds the US marketing authorisation.