Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203093
Company: GILEAD SCIENCES INC
Company: GILEAD SCIENCES INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VITEKTA | ELVITEGRAVIR | 85MG | TABLET;ORAL | Discontinued | None | Yes | No |
| VITEKTA | ELVITEGRAVIR | 150MG | TABLET;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 09/24/2014 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203093s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203093Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203093Orig1VITEKTAtoc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/21/2016 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/2015 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203093s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203093Orig1s002ltr.pdf | |
| 07/16/2015 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/27/2015 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203093s002lbl.pdf | |
| 07/27/2015 | SUPPL-2 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203093s002lbl.pdf | |
| 09/24/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203093s000lbl.pdf |