Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021286
Company: DAIICHI SANKYO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BENICAR OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription AB Yes No
BENICAR OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription AB Yes No
BENICAR OLMESARTAN MEDOXOMIL 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
04/25/2002 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21286lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21286.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-286_Benicar.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/17/2019 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021286s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021286Orig1s040ltr.pdf
11/01/2016 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021286s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021286Orig1s036ltr.pdf
07/08/2016 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

06/10/2016 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

09/23/2014 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021286Orig1s032ltr.pdf
06/27/2014 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021286Orig1s031ltr.pdf
06/13/2014 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021286Orig1s030ltr.pdf
07/03/2014 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/07/2014 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/03/2013 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021286s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021286Orig1s027ltr.pdf
12/11/2012 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286Orig1s026ltr_r.pdf
09/28/2012 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286Orig1s025ltr.pdf
02/01/2013 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

03/29/2012 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286s023ltr.pdf
02/15/2012 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286s021ltr.pdf
06/06/2011 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021286s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021286s020ltr.pdf
05/19/2011 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021286s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021286s019ltr.pdf
02/04/2010 SUPPL-18 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021286s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021286s018ltr.pdf
09/26/2007 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021286s012ltr.pdf
07/13/2005 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021286s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021286s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021286Orig1s010.pdf
11/12/2004 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21286s006ltr.pdf
02/12/2003 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21286slr002ltr.pdf
10/25/2002 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21286slr001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/17/2019 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021286s040lbl.pdf
11/01/2016 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021286s036lbl.pdf
09/23/2014 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s032lbl.pdf
06/27/2014 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s031lbl.pdf
06/13/2014 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s030lbl.pdf
07/03/2013 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021286s027lbl.pdf
12/11/2012 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s026lbl.pdf
09/28/2012 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s025lbl.pdf
03/29/2012 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s023lbl.pdf
02/15/2012 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s021lbl.pdf
06/06/2011 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021286s020lbl.pdf
05/19/2011 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021286s019lbl.pdf
02/04/2010 SUPPL-18 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021286s018lbl.pdf
07/13/2005 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021286s010lbl.pdf
04/25/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21286lbl.pdf

BENICAR

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENICAR OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription Yes AB 021286 DAIICHI SANKYO
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 207662 ACCORD HLTHCARE
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 203012 ALEMBIC PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 206763 ALKEM LABS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 204798 AUROBINDO PHARMA LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 203281 GLENMARK PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 205482 JUBILANT GENERICS
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 206631 LUPIN LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 204814 MACLEODS PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 206372 MICRO LABS
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 078276 MYLAN
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 210552 QILU
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 208130 SCIEGEN PHARMS INC
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 211049 SUNSHINE LAKE
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 202375 TORRENT
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 207135 UMEDICA LABS PVT LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 205192 ZYDUS PHARMS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENICAR OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription Yes AB 021286 DAIICHI SANKYO
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 207662 ACCORD HLTHCARE
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 203012 ALEMBIC PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 206763 ALKEM LABS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 204798 AUROBINDO PHARMA LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 203281 GLENMARK PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 205482 JUBILANT GENERICS
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 206631 LUPIN LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 204814 MACLEODS PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 206372 MICRO LABS
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 078276 MYLAN
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 210552 QILU
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 208130 SCIEGEN PHARMS INC
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 211049 SUNSHINE LAKE
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 202375 TORRENT
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 207135 UMEDICA LABS PVT LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 205192 ZYDUS PHARMS

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENICAR OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription Yes AB 021286 DAIICHI SANKYO
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 207662 ACCORD HLTHCARE
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 203012 ALEMBIC PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 206763 ALKEM LABS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 204798 AUROBINDO PHARMA LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 203281 GLENMARK PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 205482 JUBILANT GENERICS
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 206631 LUPIN LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 204814 MACLEODS PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 206372 MICRO LABS
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 078276 MYLAN
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 210552 QILU
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 208130 SCIEGEN PHARMS INC
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 211049 SUNSHINE LAKE
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 202375 TORRENT
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 207135 UMEDICA LABS PVT LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 205192 ZYDUS PHARMS

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