Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208215
Company: GILEAD SCIENCES INC
Company: GILEAD SCIENCES INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DESCOVY | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | 200MG;EQ 25MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
DESCOVY | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | 120MG;EQ 15MG BASE | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
04/04/2016 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208215s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208215Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208215Orig1_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208215Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/07/2022 | SUPPL-20 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208215Orig1s020ltr.pdf | |
09/15/2021 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/0208215Orig1s019ltr.pdf | |
03/04/2021 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208215Orig1s017ltr.pdf | |
11/24/2020 | SUPPL-14 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208215Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208215Orig1s014ltr.pdf | ||
10/03/2019 | SUPPL-12 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208215s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208215Orig1s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/208215Orig1s012.pdf | |
12/03/2019 | SUPPL-11 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208215s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208215Orig1s011ltr.pdf | |
09/28/2017 | SUPPL-5 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208215s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208215Orig1s005ltr.pdf | |
04/07/2017 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208215s001lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/07/2022 | SUPPL-20 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s020lbl.pdf | |
09/15/2021 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s019lbl.pdf | |
03/04/2021 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s017lbl.pdf | |
11/24/2020 | SUPPL-14 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208215Orig1s014lbl.pdf | |
12/03/2019 | SUPPL-11 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208215s011lbl.pdf | |
10/03/2019 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208215s012lbl.pdf | |
09/28/2017 | SUPPL-5 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208215s005lbl.pdf | |
04/07/2017 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208215s001lbl.pdf | |
04/04/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208215s000lbl.pdf |
DESCOVY
TABLET;ORAL; 200MG;EQ 25MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DESCOVY | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | 200MG;EQ 25MG BASE | TABLET;ORAL | Prescription | Yes | AB | 208215 | GILEAD SCIENCES INC |
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | 200MG;EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 213926 | LUPIN LTD |
TABLET;ORAL; 120MG;EQ 15MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DESCOVY | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | 120MG;EQ 15MG BASE | TABLET;ORAL | Prescription | Yes | AB | 208215 | GILEAD SCIENCES INC |