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CRESTOR از شرکت IPR

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اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

CRESTOR از شرکت IPR

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


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

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
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
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 079168 ALLIED
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 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 079171 SANDOZ 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 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 079168 ALLIED
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 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 079171 SANDOZ 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 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 079168 ALLIED
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 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 079171 SANDOZ 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 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 079168 ALLIED
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 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 079171 SANDOZ 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 079167 WATSON LABS INC
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET;ORAL Prescription No AB 212059 ZHEJIANG YONGTAI
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