Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020838
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATACAND CANDESARTAN CILEXETIL 4MG TABLET;ORAL Prescription AB Yes No
ATACAND CANDESARTAN CILEXETIL 8MG TABLET;ORAL Prescription AB Yes No
ATACAND CANDESARTAN CILEXETIL 16MG TABLET;ORAL Prescription AB Yes No
ATACAND CANDESARTAN CILEXETIL 32MG 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
06/04/1998 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20838lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20838ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20838_Atacand.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/09/2016 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020838s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020838Orig1s039ltr.pdf
04/26/2013 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020838s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020838Orig1s038ltr.pdf
02/21/2013 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

02/06/2015 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020838s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020838Orig1s036ltr.pdf
04/27/2012 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020838s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020838s035ltr.pdf
06/24/2011 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020838s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020838s033ltr.pdf
04/13/2012 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020838s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020838s032ltr.pdf
10/22/2009 SUPPL-31 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020838s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020838s031ltr.pdf
08/17/2006 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020838s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020838s026LTR.pdf
02/22/2005 SUPPL-24 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20838s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20838s024ltr.pdf
12/16/2004 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20838s023ltr.pdf
05/18/2005 SUPPL-22 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020838s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020838s022ltr.pdf
04/23/2003 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20838slr019ltr.pdf
01/22/2003 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20838slr017ltr.pdf
11/28/2001 SUPPL-16 Labeling

Label is not available on this site.

09/13/2002 SUPPL-15 Efficacy-Accelerated Approval Confirmatory Study Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20838s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20838se4-015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20838s015_Atacand.cfm
10/04/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/2001 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/24/2001 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/02/2001 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/07/2001 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/27/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/14/2000 SUPPL-8 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20838-s008_atacand.pdf
12/08/1999 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/11/1999 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/28/1999 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/07/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/09/2016 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020838s039lbl.pdf
02/06/2015 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020838s036lbl.pdf
04/26/2013 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020838s038lbl.pdf
04/27/2012 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020838s035lbl.pdf
04/13/2012 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020838s032lbl.pdf
06/24/2011 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020838s033lbl.pdf
10/22/2009 SUPPL-31 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020838s031lbl.pdf
08/17/2006 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020838s026lbl.pdf
05/18/2005 SUPPL-22 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020838s022lbl.pdf
02/22/2005 SUPPL-24 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20838s024lbl.pdf
09/13/2002 SUPPL-15 Efficacy-Accelerated Approval Confirmatory Study Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20838s015lbl.pdf
06/04/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20838lbl.pdf

ATACAND

TABLET;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATACAND CANDESARTAN CILEXETIL 4MG TABLET;ORAL Prescription Yes AB 020838 ASTRAZENECA
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 4MG TABLET;ORAL Prescription No AB 202079 APOTEX INC
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 4MG TABLET;ORAL Prescription No AB 203813 MACLEODS PHARMS LTD
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 4MG TABLET;ORAL Prescription No AB 078702 SANDOZ
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 4MG TABLET;ORAL Prescription No AB 091390 ZYDUS PHARMS USA INC

TABLET;ORAL; 8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATACAND CANDESARTAN CILEXETIL 8MG TABLET;ORAL Prescription Yes AB 020838 ASTRAZENECA
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 8MG TABLET;ORAL Prescription No AB 202079 APOTEX INC
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 8MG TABLET;ORAL Prescription No AB 203813 MACLEODS PHARMS LTD
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 8MG TABLET;ORAL Prescription No AB 078702 SANDOZ
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 8MG TABLET;ORAL Prescription No AB 091390 ZYDUS PHARMS USA INC

TABLET;ORAL; 16MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATACAND CANDESARTAN CILEXETIL 16MG TABLET;ORAL Prescription Yes AB 020838 ASTRAZENECA
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 16MG TABLET;ORAL Prescription No AB 202079 APOTEX INC
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 16MG TABLET;ORAL Prescription No AB 203813 MACLEODS PHARMS LTD
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 16MG TABLET;ORAL Prescription No AB 078702 SANDOZ
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 16MG TABLET;ORAL Prescription No AB 091390 ZYDUS PHARMS USA INC

TABLET;ORAL; 32MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATACAND CANDESARTAN CILEXETIL 32MG TABLET;ORAL Prescription Yes AB 020838 ASTRAZENECA
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 32MG TABLET;ORAL Prescription No AB 209119 ALEMBIC PHARMS LTD
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 32MG TABLET;ORAL Prescription No AB 202079 APOTEX INC
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 32MG TABLET;ORAL Prescription No AB 203813 MACLEODS PHARMS LTD
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 32MG TABLET;ORAL Prescription No AB 078702 SANDOZ
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 32MG TABLET;ORAL Prescription No AB 091390 ZYDUS PHARMS USA INC

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