Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205834
Company: GILEAD SCIENCES INC
Company: GILEAD SCIENCES INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HARVONI | LEDIPASVIR; SOFOSBUVIR | 90MG;400MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| HARVONI | LEDIPASVIR; SOFOSBUVIR | 45MG;200MG | TABLET;ORAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/10/2014 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205834s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205834Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205834Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205834Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/05/2020 | SUPPL-32 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205834s032,212477s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205834Orig1s032, 212477Orig1s003ltr.pdf | |
| 09/19/2019 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205834s031,212477s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205834Orig1s031, 212477Orig1s001ltr.pdf | |
| 08/28/2019 | SUPPL-29 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205834s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205834Orig1s029ltr.pdf | |
| 11/15/2019 | SUPPL-28 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205834s028,212477s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205834Orig1s028, 212477Orig1s002ltr.pdf | |
| 11/09/2017 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205834s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205834Orig1s024ltr.pdf | |
| 02/14/2017 | SUPPL-18 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205834s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205834Orig1s018ltr.pdf | |
| 04/07/2017 | SUPPL-17 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205834s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205834Orig1s017ltr.pdf | |
| 06/22/2016 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/2016 | SUPPL-11 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834Orig1s011Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s011ltr.pdf | |
| 06/08/2016 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s010ltr.pdf | |
| 02/12/2016 | SUPPL-9 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s007,s008,s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/205834Orig1s007, s008, s009SumR.pdf | |
| 02/12/2016 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s007,s008,s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/205834Orig1s007, s008, s009SumR.pdf | |
| 02/12/2016 | SUPPL-7 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s007,s008,s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/205834Orig1s007, s008, s009SumR.pdf | |
| 11/12/2015 | SUPPL-6 | Labeling-Package Insert, Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s006ltr.pdf | |
| 11/12/2015 | SUPPL-5 | Efficacy-New Indication, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s003,s005ltr.pdf | |
| 11/12/2015 | SUPPL-4 | Efficacy-New Dosing Regimen, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s004ltr.pdf | |
| 11/12/2015 | SUPPL-3 | Efficacy-New Indication, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s003,s005ltr.pdf | |
| 11/12/2015 | SUPPL-2 | Efficacy-New Patient Population, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s002ltr.pdf | |
| 03/20/2015 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/05/2020 | SUPPL-32 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205834s032,212477s003lbl.pdf | |
| 03/05/2020 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205834s032,212477s003lbl.pdf | |
| 11/15/2019 | SUPPL-28 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205834s028,212477s002lbl.pdf | |
| 09/19/2019 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205834s031,212477s001lbl.pdf | |
| 08/28/2019 | SUPPL-29 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205834s029lbl.pdf | |
| 11/09/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205834s024lbl.pdf | |
| 04/07/2017 | SUPPL-17 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205834s017lbl.pdf | |
| 02/14/2017 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205834s018lbl.pdf | |
| 02/14/2017 | SUPPL-18 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205834s018lbl.pdf | |
| 06/08/2016 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s010lbl.pdf | |
| 02/17/2016 | SUPPL-11 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834Orig1s011Lbl.pdf | |
| 02/12/2016 | SUPPL-9 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf | |
| 02/12/2016 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf | |
| 02/12/2016 | SUPPL-7 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf | |
| 11/12/2015 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s006lbl.pdf | |
| 11/12/2015 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s006lbl.pdf | |
| 11/12/2015 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s003s005lbl.pdf | |
| 11/12/2015 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s003s005lbl.pdf | |
| 11/12/2015 | SUPPL-4 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s004lbl.pdf | |
| 11/12/2015 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s004lbl.pdf | |
| 11/12/2015 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s003s005lbl.pdf | |
| 11/12/2015 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s003s005lbl.pdf | |
| 11/12/2015 | SUPPL-2 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s002lbl.pdf | |
| 11/12/2015 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s002lbl.pdf | |
| 03/20/2015 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s001lbl.pdf | |
| 03/20/2015 | SUPPL-1 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s001lbl.pdf | |
| 10/10/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205834s000lbl.pdf |