Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021366
Company: IPR
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 |
|---|---|---|---|---|---|
| 07/31/2024 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021366s046lbl.pdf | |
| 07/27/2023 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021366s045lbl.pdf | |
| 01/13/2023 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021366s043s044lbl.pdf | |
| 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 |