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Rosuvastatin Calcium

Sold as Crestor, Ezallor Sprinkle. Every branded application for this active ingredient, and 29 generic applications.

  • First approved: Aug 12, 2003
  • Branded applications: 31
  • New uses approved: 11
  • Complete response letters: 1

Applications

NDAs and BLAs for this ingredient, oldest first; each opens its full history
ApprovedApplicationSponsorSupplementsMarketing
Aug 12, 2003CrestorNDA 21366 · New molecular entityAstrazeneca31Marketed
Apr 29, 2016Rosuvastatin CalciumANDA 79167Watson Labs Inc5Marketed
Jul 19, 2016Rosuvastatin CalciumANDA 79145Apotex7Discontinued
Jul 19, 2016Rosuvastatin CalciumANDA 79161Strides Pharma Intl6Discontinued
Jul 19, 2016Rosuvastatin CalciumANDA 79166Teva Pharms USA3Discontinued
Jul 19, 2016Rosuvastatin CalciumANDA 79168Chartwell Rx3Marketed
Jul 19, 2016Rosuvastatin CalciumANDA 79169Sun Pharm9Discontinued
Jul 19, 2016Rosuvastatin CalciumANDA 79170Aurobindo Pharma Ltd9Marketed
Jul 19, 2016Rosuvastatin CalciumANDA 79171Sandoz8Discontinued
Jul 19, 2016Rosuvastatin CalciumANDA 79172Glenmark Speclt9Marketed
Oct 31, 2016Rosuvastatin CalciumANDA 201619Torrent10Marketed
Oct 31, 2016Rosuvastatin CalciumANDA 206434Accord Hlthcare8Marketed
Oct 31, 2016Rosuvastatin CalciumANDA 207062Renata2Marketed
Oct 31, 2016Rosuvastatin CalciumANDA 207408Changzhou Pharm7Marketed
Oct 31, 2016Rosuvastatin CalciumANDA 207616Hetero Labs Ltd V6Marketed
Oct 31, 2016Rosuvastatin CalciumANDA 207752Biocon Pharma7Marketed
Nov 23, 2016Rosuvastatin CalciumANDA 207453Cadila Pharms Ltd5Marketed
Mar 21, 2017Rosuvastatin CalciumANDA 206465Alkem Labs Ltd9Marketed
Jul 31, 2017Rosuvastatin CalciumANDA 205587Lupin5Discontinued
Nov 22, 2017Rosuvastatin CalciumANDA 208898Msn5Marketed
Oct 16, 2018Rosuvastatin CalciumANDA 208850Amneal Pharms Co5Discontinued
Dec 18, 2018Ezallor SprinkleNDA 208647 · New formulation or manufacturerSun Pharm11Discontinued
Mar 1, 2019Rosuvastatin CalciumANDA 206513Zhejiang Jingxin0Marketed
Apr 9, 2019Rosuvastatin CalciumANDA 207626Umedica6Marketed
Apr 24, 2019Rosuvastatin CalciumANDA 206381Sciegen Pharms7Marketed
May 7, 2019Rosuvastatin CalciumANDA 207375Shandong0Marketed
Nov 4, 2019Rosuvastatin CalciumANDA 212059Zhejiang Yongtai1Marketed
Apr 1, 2020Rosuvastatin CalciumANDA 210667Sunshine0Marketed
Feb 5, 2021Rosuvastatin CalciumANDA 207653Inventia0Discontinued
Nov 6, 2024Rosuvastatin CalciumANDA 207296Macleods Pharms1Discontinued
May 16, 2025Rosuvastatin CalciumANDA 206603Mankind Pharma1Discontinued

Complete Response Letters

FDA's published letters for these applications
LetterProductNow
Jun 22, 2016RosuvastatinFacility InspectionsApproved

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Drugs@FDA

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.