Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022081
Company: GILEAD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LETAIRIS AMBRISENTAN 5MG TABLET;ORAL Prescription AB Yes No
LETAIRIS AMBRISENTAN 10MG 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
06/15/2007 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022081s000_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022081s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022081s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/2018 SUPPL-40 Labeling-Package Insert, Labeling-Medication Guide, REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022081Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022081s040ltr.pdf
03/28/2019 SUPPL-39 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022081Orig1s039ltr.pdf
09/27/2017 SUPPL-38 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022081Orig1s038ltr.pdf
07/21/2017 SUPPL-37 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022081Orig1s037ltr.pdf
12/15/2016 SUPPL-36 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022081Orig1s036ltr.pdf
03/21/2016 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

09/25/2015 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/02/2015 SUPPL-33 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022081s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022081Orig1s033ltr.pdf
10/29/2014 SUPPL-32 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022081Orig1s032ltr.pdf
01/31/2014 SUPPL-30 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022081s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022081Orig1s030ltr.pdf
05/05/2014 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022081s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022081Orig1s029ltr.pdf
09/26/2014 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/02/2014 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/16/2013 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/10/2013 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/19/2012 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022081s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022081Orig1s022ltr.pdf
08/17/2013 SUPPL-19 REMS-Modified, REMS-Assessment Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022081s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022081Orig1s019ltr.pdf
07/19/2011 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022081s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022081s018ltr.pdf
03/03/2011 SUPPL-17 Labeling-Package Insert, REMS-Modified Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022081s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022081s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022081Orig1s017.pdf
08/24/2010 SUPPL-16 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022081s016ltr.pdf
02/15/2012 SUPPL-14 Efficacy-Labeling Change With Clinical Data, REMS-Assessment Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022081s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022081s014ltr.pdf
10/13/2010 SUPPL-12 Labeling, REMS-Assessment Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022081s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022081s012ltr.pdf
07/01/2009 SUPPL-11 REMS-Modified, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022081s011ltr.pdf
08/05/2009 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022081s010ltr.pdf
05/29/2009 SUPPL-8 REMS-Proposal, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022081s008ltr.pdf
10/08/2008 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022081s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022081s004ltr.pdf
02/14/2008 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022081s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022081s002ltr.pdf
11/29/2007 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022081s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/30/2018 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022081Orig1s040lbl.pdf
11/30/2018 SUPPL-40 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022081Orig1s040lbl.pdf
11/30/2018 SUPPL-40 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022081Orig1s040lbl.pdf
10/02/2015 SUPPL-33 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022081s033lbl.pdf
05/05/2014 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022081s029lbl.pdf
01/31/2014 SUPPL-30 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022081s030lbl.pdf
08/17/2013 SUPPL-19 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022081s019lbl.pdf
08/17/2013 SUPPL-19 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022081s019lbl.pdf
10/19/2012 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022081s022lbl.pdf
02/15/2012 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022081s014lbl.pdf
02/15/2012 SUPPL-14 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022081s014lbl.pdf
07/19/2011 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022081s018lbl.pdf
03/03/2011 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022081s017lbl.pdf
03/03/2011 SUPPL-17 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022081s017lbl.pdf
10/13/2010 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022081s012lbl.pdf
10/13/2010 SUPPL-12 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022081s012lbl.pdf
08/05/2009 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s010lbl.pdf
07/01/2009 SUPPL-11 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s011lbl.pdf
07/01/2009 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s011lbl.pdf
05/29/2009 SUPPL-8 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s008lbl.pdf
05/29/2009 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s008lbl.pdf
10/08/2008 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022081s004lbl.pdf
02/14/2008 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022081s002lbl.pdf
06/15/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022081s000_LBL.pdf

LETAIRIS

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription No AB 210715 CIPLA
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription No AB 208441 MYLAN
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription No AB 209509 PAR PHARM INC
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription No AB 208354 SIGMAPHARM LABS LLC
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription No AB 210784 SUN PHARM
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription No AB 208252 WATSON LABS INC
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription No AB 210058 ZYDUS PHARMS
LETAIRIS AMBRISENTAN 5MG TABLET;ORAL Prescription Yes AB 022081 GILEAD

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMBRISENTAN AMBRISENTAN 10MG TABLET;ORAL Prescription No AB 210715 CIPLA
AMBRISENTAN AMBRISENTAN 10MG TABLET;ORAL Prescription No AB 208441 MYLAN
AMBRISENTAN AMBRISENTAN 10MG TABLET;ORAL Prescription No AB 209509 PAR PHARM INC
AMBRISENTAN AMBRISENTAN 10MG TABLET;ORAL Prescription No AB 208354 SIGMAPHARM LABS LLC
AMBRISENTAN AMBRISENTAN 10MG TABLET;ORAL Prescription No AB 210784 SUN PHARM
AMBRISENTAN AMBRISENTAN 10MG TABLET;ORAL Prescription No AB 208252 WATSON LABS INC
AMBRISENTAN AMBRISENTAN 10MG TABLET;ORAL Prescription No AB 210058 ZYDUS PHARMS
LETAIRIS AMBRISENTAN 10MG TABLET;ORAL Prescription Yes AB 022081 GILEAD

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