Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022081
Company: GILEAD
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 |
|---|---|---|---|---|---|
| 06/08/2021 | SUPPL-43 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022081Orig1s043ltr.pdf |
| 12/22/2020 | SUPPL-42 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022081Orig1s042ltr.pdf |
| 08/23/2019 | SUPPL-41 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022081s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022081Orig1s041ltr.pdf | |
| 11/30/2018 | SUPPL-40 | REMS - MODIFIED - D-N-A, Labeling-Package Insert, Labeling-Medication Guide |
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)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022081Orig1s039ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/022081Orig1s039.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 | REMS-Assessment, Labeling |
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 | Labeling, REMS-Proposal |
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 |
|---|---|---|---|---|---|
| 08/23/2019 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022081s041lbl.pdf | |
| 08/23/2019 | SUPPL-41 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022081s041lbl.pdf | |
| 11/30/2018 | SUPPL-40 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022081Orig1s040lbl.pdf | |
| 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 | |
| 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 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022081s012lbl.pdf | |
| 10/13/2010 | SUPPL-12 | Labeling | 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 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s008lbl.pdf | |
| 05/29/2009 | SUPPL-8 | REMS-Proposal | 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 | 210701 | APOTEX |
| AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 216531 | AUROBINDO PHARMA |
| 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 | 210701 | APOTEX |
| AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | No | AB | 216531 | AUROBINDO PHARMA |
| 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 |