Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021896
Company: GILEAD
Company: GILEAD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EMTRIVA | EMTRICITABINE | 10MG/ML | SOLUTION;ORAL | Prescription | None | Yes | Yes |
EMTRIVA | EMTRICITABINE | 10MG/ML | SOLUTION; ORAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
09/28/2005 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021896lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021896ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021896s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/10/2018 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021896s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021896Orig1s026, 021500Orig1s029ltr.pdf | |
04/07/2017 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021500s028,021896s025lbl.pdf | |
02/20/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/08/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/02/2013 | SUPPL-18 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021500s021,021896s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021500Orig1s021,021896Orig1s018ltr.pdf | |
07/23/2012 | SUPPL-16 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021896s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021500Orig1s019,021896Orig1s016ltr.pdf | |
11/18/2011 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021500s018,021896s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021500s018,021896s015ltr.pdf | |
05/16/2008 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021500s011,021896s005ltr.pdf |
04/04/2008 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021500s010,021896s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021500s010, 021896s004ltr.pdf | |
12/22/2006 | SUPPL-1 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021896s001,021500s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021896s001,021500s007ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/10/2018 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021896s026lbl.pdf | |
04/07/2017 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021500s028,021896s025lbl.pdf | |
04/02/2013 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021500s021,021896s018lbl.pdf | |
04/02/2013 | SUPPL-18 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021500s021,021896s018lbl.pdf | |
07/23/2012 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021896s016lbl.pdf | |
07/23/2012 | SUPPL-16 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021896s016lbl.pdf | |
11/18/2011 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021500s018,021896s015lbl.pdf | |
04/04/2008 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021500s010,021896s004lbl.pdf | |
12/22/2006 | SUPPL-1 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021896s001,021500s007lbl.pdf | |
09/28/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021896lbl.pdf |