Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021937
Company: GILEAD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATRIPLA EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;200MG;300MG TABLET;ORAL Prescription None 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
07/12/2006 ORIG-1 Approval Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021937lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021937s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021937TOC2.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/07/2017 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021937s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021937Orig1s041ltr.pdf
02/11/2016 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021937s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021937Orig1s039ltr.pdf
11/20/2015 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021937s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021937Orig1s037ltr.pdf
01/12/2015 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/23/2015 SUPPL-34 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021937s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021937Orig1s034ltr.pdf
11/26/2014 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/11/2014 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

10/23/2013 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021937s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021937Orig1s031ltr.pdf
11/08/2013 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

04/17/2013 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021937s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021937Orig1s027ltr.pdf
06/14/2012 SUPPL-25 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021937s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021937s025ltr.pdf
09/16/2011 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021937s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021937s023ltr.pdf
08/06/2010 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021937s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021937s019ltr.pdf
01/07/2010 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021937s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021937s012ltr.pdf
10/18/2008 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s011ltr.pdf
06/06/2008 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s009ltr.pdf
02/28/2008 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s007ltr.pdf
02/15/2008 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s006ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/07/2017 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021937s041lbl.pdf
02/11/2016 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021937s039lbl.pdf
11/20/2015 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021937s037lbl.pdf
01/23/2015 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021937s034lbl.pdf
01/23/2015 SUPPL-34 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021937s034lbl.pdf
10/23/2013 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021937s031lbl.pdf
04/17/2013 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021937s027lbl.pdf
06/14/2012 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021937s025lbl.pdf
06/14/2012 SUPPL-25 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021937s025lbl.pdf
09/16/2011 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021937s023lbl.pdf
08/06/2010 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021937s019lbl.pdf
01/07/2010 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021937s012lbl.pdf
06/06/2008 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s009lbl.pdf
02/28/2008 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s007lbl.pdf
02/15/2008 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s006lbl.pdf
07/12/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021937lbl.pdf

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