Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022100
Company: DAIICHI SANKYO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET;ORAL Prescription AB Yes No
AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET;ORAL Prescription AB Yes No
AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET;ORAL Prescription AB Yes No
AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;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
09/26/2007 ORIG-1 Approval Type 4 - New Combination STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022100s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022100_azor_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/05/2017 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022100s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022100Orig1s033ltr.pdf
11/01/2016 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022100s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022100Orig1s032ltr.pdf
12/09/2016 SUPPL-30 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022100Orig1s030ltr.pdf
07/08/2016 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

06/04/2015 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/09/2015 SUPPL-27 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/2014/022100s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022100Orig1s026ltr.pdf
07/02/2014 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022100Orig1s025ltr.pdf
06/13/2014 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022100Orig1s024ltr.pdf
05/14/2014 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/2013/022100s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022100Orig1s022ltr.pdf
12/11/2012 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022100Orig1s020ltr_r.pdf
09/28/2012 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022100Orig1s019ltr.pdf
02/01/2013 SUPPL-18 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/2012/022100s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022100s016ltr.pdf
11/02/2011 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022100s014ltr.pdf
11/14/2011 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022100s013ltr.pdf
05/19/2011 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022100s010,s012ltr.pdf
05/19/2011 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022100s010,s012ltr.pdf
08/07/2008 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022100s003ltr.pdf
05/11/2009 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022100s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022100s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/05/2017 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022100s033lbl.pdf
11/01/2016 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022100s032lbl.pdf
09/23/2014 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s026lbl.pdf
07/02/2014 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s025lbl.pdf
06/13/2014 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s024lbl.pdf
07/03/2013 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022100s022lbl.pdf
12/11/2012 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s020lbl.pdf
09/28/2012 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s019lbl.pdf
01/18/2012 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s016lbl.pdf
11/14/2011 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s013lbl.pdf
11/02/2011 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s014lbl.pdf
05/19/2011 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s010s012lbl.pdf
05/19/2011 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s010s012lbl.pdf
05/11/2009 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022100s002lbl.pdf
09/26/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022100lbl.pdf

AZOR

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET;ORAL Prescription No AB 207216 AJANTA PHARMA LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET;ORAL Prescription No AB 207073 ALEMBIC PHARMS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET;ORAL Prescription No AB 209042 ALKEM LABS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET;ORAL Prescription No AB 206906 AUROBINDO PHARMA LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET;ORAL Prescription No AB 207807 GLENMARK PHARMS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET;ORAL Prescription No AB 207450 JUBILANT GENERICS
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET;ORAL Prescription No AB 206884 MACLEODS PHARMS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET;ORAL Prescription No AB 207435 MICRO LABS
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET;ORAL Prescription No AB 091154 TEVA PHARMS USA
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET;ORAL Prescription No AB 202933 TORRENT PHARMS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET;ORAL Prescription No AB 207771 ZYDUS PHARMS USA INC
AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET;ORAL Prescription Yes AB 022100 DAIICHI SANKYO

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 207216 AJANTA PHARMA LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 207073 ALEMBIC PHARMS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 209042 ALKEM LABS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 206906 AUROBINDO PHARMA LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 207807 GLENMARK PHARMS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 207450 JUBILANT GENERICS
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 206884 MACLEODS PHARMS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 207435 MICRO LABS
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 091154 TEVA PHARMS USA
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 202933 TORRENT PHARMS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 207771 ZYDUS PHARMS USA INC
AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET;ORAL Prescription Yes AB 022100 DAIICHI SANKYO

TABLET;ORAL; EQ 10MG BASE;20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET;ORAL Prescription No AB 207216 AJANTA PHARMA LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET;ORAL Prescription No AB 207073 ALEMBIC PHARMS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET;ORAL Prescription No AB 209042 ALKEM LABS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET;ORAL Prescription No AB 206906 AUROBINDO PHARMA LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET;ORAL Prescription No AB 207807 GLENMARK PHARMS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET;ORAL Prescription No AB 207450 JUBILANT GENERICS
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET;ORAL Prescription No AB 206884 MACLEODS PHARMS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET;ORAL Prescription No AB 207435 MICRO LABS
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET;ORAL Prescription No AB 091154 TEVA PHARMS USA
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET;ORAL Prescription No AB 202933 TORRENT PHARMS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET;ORAL Prescription No AB 207771 ZYDUS PHARMS USA INC
AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET;ORAL Prescription Yes AB 022100 DAIICHI SANKYO

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 207216 AJANTA PHARMA LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 207073 ALEMBIC PHARMS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 209042 ALKEM LABS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 206906 AUROBINDO PHARMA LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 207807 GLENMARK PHARMS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 207450 JUBILANT GENERICS
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 206884 MACLEODS PHARMS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 207435 MICRO LABS
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 091154 TEVA PHARMS USA
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 202933 TORRENT PHARMS LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 207771 ZYDUS PHARMS USA INC
AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET;ORAL Prescription Yes AB 022100 DAIICHI SANKYO

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