Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202258
Company: MERCK SHARP DOHME
Company: MERCK SHARP DOHME
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VICTRELIS | BOCEPREVIR | 200MG | CAPSULE;ORAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 05/13/2011 | 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/2011/202258lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202258Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202258Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202258Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/30/2017 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202258s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202258Orig1s016ltr.pdf | |
| 07/28/2014 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s015ltr.pdf | |
| 02/24/2014 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s014ltr.pdf | |
| 02/07/2014 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s013ltr.pdf | |
| 01/17/2014 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s012ltr.pdf | |
| 04/09/2014 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s011ltr.pdf | |
| 09/18/2013 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s009ltr.pdf | |
| 07/22/2013 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/2013 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s007ltr.pdf | |
| 12/21/2012 | SUPPL-6 | Labeling, Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258Orig1s006ltr.pdf | |
| 11/02/2012 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258Orig1s005ltr.pdf | |
| 02/27/2013 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s004ltr.pdf | |
| 02/13/2013 | SUPPL-3 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s003ltr.pdf | |
| 04/20/2012 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258s002ltr.pdf | |
| 07/30/2012 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/30/2017 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202258s016lbl.pdf | |
| 01/30/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202258s016lbl.pdf | |
| 07/28/2014 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s015lbl.pdf | |
| 07/28/2014 | SUPPL-15 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s015lbl.pdf | |
| 04/09/2014 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s011lbl.pdf | |
| 02/24/2014 | SUPPL-14 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s014lbl.pdf | |
| 02/24/2014 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s014lbl.pdf | |
| 02/07/2014 | SUPPL-13 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s013lbl.pdf | |
| 02/07/2014 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s013lbl.pdf | |
| 01/17/2014 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s012lbl.pdf | |
| 01/17/2014 | SUPPL-12 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s012lbl.pdf | |
| 09/18/2013 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s009lbl.pdf | |
| 02/27/2013 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s004lbl.pdf | |
| 02/15/2013 | SUPPL-7 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s007lbl.pdf | |
| 02/15/2013 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s007lbl.pdf | |
| 02/13/2013 | SUPPL-3 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s003lbl.pdf | |
| 12/21/2012 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s006lbl.pdf | |
| 12/21/2012 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s006lbl.pdf | |
| 12/21/2012 | SUPPL-6 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s006lbl.pdf | |
| 11/02/2012 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s005lbl.pdf | |
| 07/30/2012 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s001lbl.pdf | |
| 04/20/2012 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s002lbl.pdf | |
| 04/20/2012 | SUPPL-2 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s002lbl.pdf | |
| 05/13/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202258lbl.pdf |