Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022577
Company: GILEAD SCIENCES INC
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-Patient Package Insert, Labeling-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-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s047,022577s004lbl.pdf | |
04/02/2013 | SUPPL-4 | Labeling-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 |