Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202123
Company: GILEAD SCIENCES INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COMPLERA EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE 200MG;EQ 25MG BASE;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
08/10/2011 ORIG-1 Approval Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202123s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202123s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202123_compleratm_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202123Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2018 SUPPL-29 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202123s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202123Orig1s029ltr.pdf
04/07/2017 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202123s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202123Orig1s027ltr.pdf
03/09/2016 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/23/2016 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202123s021s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202123Orig1s021,s024.pdf
02/09/2016 SUPPL-23 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202123s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202123Orig1s023ltr.pdf
12/29/2015 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/23/2016 SUPPL-21 Efficacy-New Patient Population Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202123Orig1s021,s024.pdf
05/05/2015 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202123s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202123Orig1s020ltr.pdf
09/16/2014 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202123s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202123Orig1s018ltr.pdf
07/11/2014 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/05/2014 SUPPL-16 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202123s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202123Orig1s016ltr.pdf
10/23/2013 SUPPL-15 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s015ltr.pdf
11/08/2013 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/13/2013 SUPPL-12 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s012ltr.pdf
06/20/2013 SUPPL-11 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s011ltr.pdf
05/10/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/19/2013 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/26/2013 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/10/2012 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202123s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202123Orig1s006ltr.pdf
01/25/2013 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/31/2018 SUPPL-29 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202123s029lbl.pdf
04/07/2017 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202123s027lbl.pdf
02/23/2016 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202123s021s024lbl.pdf
02/09/2016 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202123s023lbl.pdf
02/09/2016 SUPPL-23 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202123s023lbl.pdf
05/05/2015 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202123s020lbl.pdf
09/16/2014 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202123s018lbl.pdf
06/05/2014 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202123s016lbl.pdf
06/05/2014 SUPPL-16 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202123s016lbl.pdf
12/13/2013 SUPPL-12 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s012lbl.pdf
10/23/2013 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s015lbl.pdf
10/23/2013 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s015lbl.pdf
06/20/2013 SUPPL-11 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s011lbl.pdf
06/20/2013 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s011lbl.pdf
01/25/2013 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s003lbl.pdf
08/10/2012 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202123s006lbl.pdf
08/10/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202123s000lbl.pdf

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