Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021532
Company: DAIICHI SANKYO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BENICAR HCT HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET;ORAL Prescription AB Yes No
BENICAR HCT HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription AB Yes No
BENICAR HCT HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG 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
06/05/2003 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21532_benicar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21532ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021532_benicar_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/13/2016 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/23/2014 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021532Orig1s026ltr.pdf
06/27/2014 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021532Orig1s025ltr.pdf
06/13/2014 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021532Orig1s024ltr.pdf
05/07/2014 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/03/2013 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021532s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021532Orig1s022ltr.pdf
12/11/2012 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021532Orig1s021ltr_r.pdf
09/18/2012 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021532Orig1s020ltr.pdf
02/01/2013 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/18/2012 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021532s016ltr.pdf
02/11/2016 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021532s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021532Orig1s015ltr.pdf
05/03/2011 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021532s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021532s013,s014ltr.pdf
05/03/2011 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021532s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021532s013,s014ltr.pdf
11/16/2007 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021532s008ltr.pdf
07/13/2005 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021532s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021532s004ltr.pdf
11/12/2004 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21532s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/11/2016 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021532s015lbl.pdf
09/23/2014 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s026lbl.pdf
06/27/2014 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s025lbl.pdf
06/13/2014 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s024lbl.pdf
07/03/2013 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021532s022lbl.pdf
12/11/2012 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s021lbl.pdf
09/18/2012 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s020lbl.pdf
01/18/2012 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s016lbl.pdf
05/03/2011 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021532s013s014lbl.pdf
05/03/2011 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021532s013s014lbl.pdf
07/13/2005 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021532s004lbl.pdf
06/05/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21532_benicar_lbl.pdf

BENICAR HCT

TABLET;ORAL; 12.5MG;20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENICAR HCT HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET;ORAL Prescription Yes AB 021532 DAIICHI SANKYO
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET;ORAL Prescription No AB 209281 ACCORD HLTHCARE
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET;ORAL Prescription No AB 204233 ALEMBIC PHARMS LTD
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET;ORAL Prescription No AB 205391 AUROBINDO PHARMA LTD
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET;ORAL Prescription No AB 078827 MYLAN
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET;ORAL Prescription No AB 207804 PRINSTON INC
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET;ORAL Prescription No AB 206515 TORRENT

TABLET;ORAL; 12.5MG;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENICAR HCT HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription Yes AB 021532 DAIICHI SANKYO
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription No AB 209281 ACCORD HLTHCARE
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription No AB 204233 ALEMBIC PHARMS LTD
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription No AB 205391 AUROBINDO PHARMA LTD
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription No AB 078827 MYLAN
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription No AB 207804 PRINSTON INC
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription No AB 200532 TEVA PHARMS USA
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription No AB 206515 TORRENT

TABLET;ORAL; 25MG;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENICAR HCT HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET;ORAL Prescription Yes AB 021532 DAIICHI SANKYO
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET;ORAL Prescription No AB 209281 ACCORD HLTHCARE
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET;ORAL Prescription No AB 204233 ALEMBIC PHARMS LTD
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET;ORAL Prescription No AB 205391 AUROBINDO PHARMA LTD
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET;ORAL Prescription No AB 078827 MYLAN
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET;ORAL Prescription No AB 207804 PRINSTON INC
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET;ORAL Prescription No AB 206515 TORRENT

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