Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 214187
Company: GILEAD SCIENCES INC
Company: GILEAD SCIENCES INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EPCLUSA | SOFOSBUVIR; VELPATASVIR | 150MG;37.5MG/PACKET | PELLETS;ORAL | Prescription | None | Yes | No |
EPCLUSA | SOFOSBUVIR; VELPATASVIR | 200MG;50MG/PACKET | PELLETS;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 |
---|---|---|---|---|---|---|---|
06/10/2021 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214187s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214187Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214187Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/27/2022 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214187s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214187Orig1s01ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/27/2022 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214187s001lbl.pdf | |
06/10/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214187s000lbl.pdf |