Coronary Heart Disease

• FDA approval · 2022-08-29
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for simvastatin from NorthStar Rx LLC under the ANDA framework, supporting continued regulatory stat…

• FDA approval · 2021-03-15
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for pravastatin sodium to allow Aurobindo Pharma Limited to market a generic pravastatin product in …

• FDA approval · 2017-06-30
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (CIPLA USA INC.)

  FDA approved a supplemental application for pravastatin sodium submitted by Cipla USA Inc., indicating an approved modification to the gener…

• FDA approval · 2009-04-03
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for simvastatin from NorthStar Rx LLC under ANDA 077691, granting approval for a change to the gener…