Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021366
Company: IPR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CRESTOR ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET;ORAL Prescription AB Yes No
CRESTOR ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription AB Yes No
CRESTOR ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET;ORAL Prescription AB Yes No
CRESTOR ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/25/2020 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021366s042lbl.pdf
05/21/2020 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021366s040s041lbl.pdf
05/21/2020 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021366s040s041lbl.pdf
11/09/2018 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021366s038lbl.pdf
08/04/2017 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021366s037lbl.pdf
05/27/2016 SUPPL-33 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021366s033lbl.pdf
11/20/2015 SUPPL-31 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021366s031lbl.pdf
06/01/2015 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021366s032lbl.pdf
06/01/2015 SUPPL-32 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021366s032lbl.pdf
07/08/2014 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021366s030lbl.pdf
08/07/2013 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021366s028s029lbl.pdf
08/07/2013 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021366s028s029lbl.pdf
12/20/2012 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366s026lbl.pdf
10/31/2012 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366s025s027lbl.pdf
10/31/2012 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366s025s027lbl.pdf
02/28/2012 SUPPL-24 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366Orig1s024Lbl.pdf
11/19/2010 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021366s021lbl.pdf
02/08/2010 SUPPL-16 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021366s016lbl.pdf
01/22/2010 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021366s018lbl.pdf
10/15/2009 SUPPL-17 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021366s017lbl.pdf
03/27/2009 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021366s015lbl.pdf
01/23/2009 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021366s014lbl.pdf
11/06/2008 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021366s013lbl.pdf
11/08/2007 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021366s010lbl.pdf
07/23/2007 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021366s011lbl.pdf
03/02/2005 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21366slr005lbl.pdf
08/12/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21366_crestor_lbl.pdf

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