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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/12/2003 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21366_crestor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21366ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-366_Crestor.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/27/2023 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021366s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021366Orig1s045ltr.pdf | |
| 01/13/2023 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021366s043s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021366Orig1s043,s044ltr.pdf | |
| 01/13/2023 | SUPPL-43 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021366Orig1s043,s044ltr.pdf |
| 09/25/2020 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021366s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021366Orig1s042ltr.pdf | |
| 05/21/2020 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021366s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021366Orig1s040s041ltr.pdf | |
| 05/21/2020 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021366s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021366Orig1s040s041ltr.pdf | |
| 11/09/2018 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021366s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021366Orig1s038ltr.pdf | |
| 08/04/2017 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021366s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021366Orig1s037ltr.pdf | |
| 05/27/2016 | SUPPL-33 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021366s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021366Orig1s033ltr.pdf | |
| 06/01/2015 | SUPPL-32 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021366s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021366Orig1s032ltr.pdf | |
| 11/20/2015 | SUPPL-31 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021366s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021366Orig1s031ltr.pdf | |
| 07/08/2014 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021366s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021366Orig1s030ltr.pdf | |
| 08/07/2013 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021366s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021366Orig1s028,s029ltr.pdf | |
| 08/07/2013 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021366s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021366Orig1s028,s029ltr.pdf | |
| 10/31/2012 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366s025s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021366Orig1s025,s027ltr.pdf | |
| 12/20/2012 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021366Orig1s026ltr.pdf | |
| 10/31/2012 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366s025s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021366Orig1s025,s027ltr.pdf | |
| 02/28/2012 | SUPPL-24 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366Orig1s024Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021366Orig1s024ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021366s024.pdf | |
| 11/19/2010 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021366s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021366s021ltr.pdf | |
| 01/22/2010 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021366s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021366s018ltr.pdf | |
| 10/15/2009 | SUPPL-17 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021366s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021366s017ltr.pdf | |
| 02/08/2010 | SUPPL-16 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021366s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021366s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021366s016_crestor_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021366s016SumR.pdf | |
| 03/27/2009 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021366s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021366s015ltr.pdf | |
| 01/23/2009 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021366s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021366s014ltr.pdf | |
| 11/06/2008 | SUPPL-13 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021366s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021366s013ltr.pdf | |
| 07/23/2007 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021366s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021366s011ltr.pdf | |
| 11/08/2007 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021366s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021366s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021366s010.pdf | |
| 03/02/2005 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21366slr005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21366s005ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 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 |
CRESTOR
TABLET;ORAL; EQ 5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CRESTOR | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021366 | IPR |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 206434 | ACCORD HLTHCARE |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 206465 | ALKEM LABS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 079170 | AUROBINDO PHARMA LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 207752 | BIOCON PHARMA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 207453 | CADILA PHARMS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 207408 | CHANGZHOU PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 079168 | CHARTWELL RX |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 079172 | GLENMARK PHARMS |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 207616 | HETERO LABS LTD V |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 205587 | LUPIN |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 208898 | MSN |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 207062 | RENATA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 206381 | SCIEGEN PHARMS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 207375 | SHANDONG |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 079169 | SUN PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 201619 | TORRENT |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 207626 | UMEDICA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 079167 | WATSON LABS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 212059 | ZHEJIANG YONGTAI |
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CRESTOR | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021366 | IPR |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 206434 | ACCORD HLTHCARE |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 206465 | ALKEM LABS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 079170 | AUROBINDO PHARMA LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207752 | BIOCON PHARMA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207453 | CADILA PHARMS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207408 | CHANGZHOU PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 079168 | CHARTWELL RX |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 079172 | GLENMARK PHARMS |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207616 | HETERO LABS LTD V |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 205587 | LUPIN |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 208898 | MSN |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207062 | RENATA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 206381 | SCIEGEN PHARMS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207375 | SHANDONG |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 079169 | SUN PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 201619 | TORRENT |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207626 | UMEDICA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 079167 | WATSON LABS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 212059 | ZHEJIANG YONGTAI |
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CRESTOR | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021366 | IPR |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 206434 | ACCORD HLTHCARE |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 206465 | ALKEM LABS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 079170 | AUROBINDO PHARMA LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207752 | BIOCON PHARMA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207453 | CADILA PHARMS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207408 | CHANGZHOU PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 079168 | CHARTWELL RX |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 079172 | GLENMARK PHARMS |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207616 | HETERO LABS LTD V |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 205587 | LUPIN |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 208898 | MSN |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207062 | RENATA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 206381 | SCIEGEN PHARMS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207375 | SHANDONG |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 079169 | SUN PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 201619 | TORRENT |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207626 | UMEDICA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 079167 | WATSON LABS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 212059 | ZHEJIANG YONGTAI |
TABLET;ORAL; EQ 40MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CRESTOR | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021366 | IPR |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 206434 | ACCORD HLTHCARE |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 206465 | ALKEM LABS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 079170 | AUROBINDO PHARMA LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207752 | BIOCON PHARMA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207453 | CADILA PHARMS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207408 | CHANGZHOU PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 079168 | CHARTWELL RX |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 079172 | GLENMARK PHARMS |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207616 | HETERO LABS LTD V |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 205587 | LUPIN |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 208898 | MSN |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207062 | RENATA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 206381 | SCIEGEN PHARMS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207375 | SHANDONG |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 079169 | SUN PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 201619 | TORRENT |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207626 | UMEDICA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 079167 | WATSON LABS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 212059 | ZHEJIANG YONGTAI |