Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 200175
Company: DAIICHI SANKYO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;20MG TABLET;ORAL Prescription AB Yes No
TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;40MG TABLET;ORAL Prescription AB Yes No
TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;25MG;40MG TABLET;ORAL Prescription AB Yes No
TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;12.5MG;40MG TABLET;ORAL Prescription AB Yes No
TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;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
07/23/2010 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200175s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200175s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200175_tribenzor_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200175Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/05/2017 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200175s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200175Orig1s026ltr.pdf
11/01/2016 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200175s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200175Orig1s025ltr.pdf
09/16/2015 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/23/2014 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200175Orig1s020ltr.pdf
06/27/2014 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200175Orig1s019ltr.pdf
06/13/2014 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200175Orig1s018ltr.pdf
06/20/2014 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/03/2013 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200175s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200175Orig1s015ltr.pdf
07/03/2013 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/06/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/10/2012 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200175Orig1s012ltr.pdf
09/28/2012 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200175Orig1s011ltr.pdf
02/01/2013 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/19/2012 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200175s008ltr.pdf
11/01/2011 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200175s007ltr.pdf
06/21/2011 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200175s003ltr.pdf
03/25/2011 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200175s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/05/2017 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200175s026lbl.pdf
11/01/2016 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200175s025lbl.pdf
09/23/2014 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s020lbl.pdf
06/27/2014 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s019lbl.pdf
06/13/2014 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s018lbl.pdf
07/03/2013 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200175s015lbl.pdf
12/10/2012 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s012lbl.pdf
09/28/2012 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s011lbl.pdf
01/19/2012 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s008lbl.pdf
11/01/2011 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s007lbl.pdf
06/21/2011 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s003lbl.pdf
03/25/2011 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s001lbl.pdf
07/23/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200175s000lbl.pdf

TRIBENZOR

TABLET;ORAL; EQ 5MG BASE;12.5MG;20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;20MG TABLET;ORAL Prescription No AB 206137 PAR PHARM INC
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;20MG TABLET;ORAL Prescription No AB 203580 TORRENT
TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;20MG TABLET;ORAL Prescription Yes AB 200175 DAIICHI SANKYO

TABLET;ORAL; EQ 5MG BASE;12.5MG;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;40MG TABLET;ORAL Prescription No AB 206137 PAR PHARM INC
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;40MG TABLET;ORAL Prescription No AB 203580 TORRENT
TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;40MG TABLET;ORAL Prescription Yes AB 200175 DAIICHI SANKYO

TABLET;ORAL; EQ 5MG BASE;25MG;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;25MG;40MG TABLET;ORAL Prescription No AB 206137 PAR PHARM INC
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;25MG;40MG TABLET;ORAL Prescription No AB 203580 TORRENT
TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;25MG;40MG TABLET;ORAL Prescription Yes AB 200175 DAIICHI SANKYO

TABLET;ORAL; EQ 10MG BASE;12.5MG;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;12.5MG;40MG TABLET;ORAL Prescription No AB 206137 PAR PHARM INC
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;12.5MG;40MG TABLET;ORAL Prescription No AB 203580 TORRENT
TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;12.5MG;40MG TABLET;ORAL Prescription Yes AB 200175 DAIICHI SANKYO

TABLET;ORAL; EQ 10MG BASE;25MG;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;25MG;40MG TABLET;ORAL Prescription No AB 206137 PAR PHARM INC
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;25MG;40MG TABLET;ORAL Prescription No AB 203580 TORRENT
TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;25MG;40MG TABLET;ORAL Prescription Yes AB 200175 DAIICHI SANKYO

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