Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 203100
Company: GILEAD SCIENCES INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STRIBILD COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 150MG;150MG;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
08/27/2012 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203100s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/0203100Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203100Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203100Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/06/2019 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203100s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203100Orig1s034ltr.pdf
11/02/2018 SUPPL-33 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203100s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203100Orig1s33ltr.pdf
08/07/2018 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203100s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203100Orig1s032ltr.pdf
08/30/2017 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203100Orig1s030ltr.pdf
05/04/2017 SUPPL-29 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203100Orig1s029ltr.pdf
04/07/2017 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203100Orig1s028ltr.pdf
01/27/2017 SUPPL-25 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203100Orig1s025ltr.pdf
09/15/2016 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203100s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203100Orig1s024ltr.pdf
02/19/2016 SUPPL-21 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203100s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203100Orig1s021ltr.pdf
08/10/2015 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/28/2015 SUPPL-16 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203100s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203100Orig1s016ltr.pdf
06/08/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/07/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/17/2014 SUPPL-11 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203100s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203100Orig1s011ltr.pdf
08/28/2014 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203100s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203100Orig1s010ltr.pdf
10/23/2013 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203100s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203100Orig1s009ltr.pdf
11/08/2013 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/16/2013 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/19/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/02/2013 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203100s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203100Orig1s004ltr.pdf
05/03/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/15/2013 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/06/2019 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203100s034lbl.pdf
11/02/2018 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203100s033lbl.pdf
11/02/2018 SUPPL-33 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203100s033lbl.pdf
08/07/2018 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203100s032lbl.pdf
08/30/2017 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s030lbl.pdf
05/04/2017 SUPPL-29 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s029lbl.pdf
05/04/2017 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s029lbl.pdf
04/07/2017 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s028lbl.pdf
01/27/2017 SUPPL-25 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s025lbl.pdf
09/15/2016 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203100s024lbl.pdf
02/19/2016 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203100s021lbl.pdf
02/19/2016 SUPPL-21 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203100s021lbl.pdf
07/28/2015 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203100s016lbl.pdf
07/28/2015 SUPPL-16 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203100s016lbl.pdf
12/17/2014 SUPPL-11 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203100s011lbl.pdf
08/28/2014 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203100s010lbl.pdf
10/23/2013 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203100s009lbl.pdf
10/02/2013 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203100s004lbl.pdf
08/27/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203100s000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English