Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022577
Company: GILEAD SCIENCES INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIREAD TENOFOVIR DISOPROXIL FUMARATE 40MG/SCOOPFUL POWDER;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
01/18/2012 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022577lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022577s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022577_viread_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022577Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/24/2019 SUPPL-14 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021356s058,022577s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021356Orig1s058,022577Orig1s014ltr.pdf
12/11/2018 SUPPL-13 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021356s057,022577s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/2018/021356Orig1s057, 022577Orig1s013ltr.pdf
07/30/2018 SUPPL-12 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021356s056,022577s012lbl.pdf
04/07/2017 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021356s055,022577s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021356Orig1s055,022577Orig1s011ltr.pdf
02/16/2016 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021356s052,022577s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021356Orig1s052,022577Orig1s009ltr.pdf
12/02/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/29/2015 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021356s049,022577s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021356Orig1s049,022577Orig1s007ltr.pdf
10/23/2013 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s048,022577s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s048,022577Orig1s006ltr.pdf
04/02/2013 SUPPL-4 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s047,022577s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s047,022577Orig1s004ltr.pdf
07/24/2013 SUPPL-3 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s046,022577s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s046,022577Orig1s003ltr.pdf
08/16/2012 SUPPL-2 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s042,022577s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021356Orig1s042,022577Orig1s002ltr.pdf
08/07/2012 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s040,022577s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021356Orig1s040,022577Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/24/2019 SUPPL-14 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021356s058,022577s014lbl.pdf
04/24/2019 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021356s058,022577s014lbl.pdf
12/11/2018 SUPPL-13 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021356s057,022577s013lbl.pdf
07/30/2018 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021356s056,022577s012lbl.pdf
04/07/2017 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021356s055,022577s011lbl.pdf
02/16/2016 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021356s052,022577s009lbl.pdf
05/29/2015 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021356s049,022577s007lbl.pdf
10/23/2013 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s048,022577s006lbl.pdf
07/24/2013 SUPPL-3 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s046,022577s003lbl.pdf
04/02/2013 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s047,022577s004lbl.pdf
04/02/2013 SUPPL-4 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s047,022577s004lbl.pdf
08/16/2012 SUPPL-2 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s042,022577s002lbl.pdf
08/07/2012 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s040,022577s001lbl.pdf
01/18/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022577lbl.pdf

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