Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021500
Company: GILEAD
Company: GILEAD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EMTRIVA | EMTRICITABINE | 200MG | CAPSULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
07/02/2003 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21500_emtriva_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21500ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021500_emtriva_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/10/2018 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021500s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021896Orig1s026, 021500Orig1s029ltr.pdf | |
04/07/2017 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021500s028,021896s025lbl.pdf | |
03/25/2014 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/08/2013 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/02/2013 | SUPPL-21 | Labeling-Patient Package Insert, Labeling-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-19 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021500s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021500Orig1s019,021896Orig1s016ltr.pdf | |
11/18/2011 | SUPPL-18 | 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-11 | 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-10 | 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-7 | Labeling |
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 | |
12/02/2005 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021500s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021500s003ltr.pdf | |
06/13/2005 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021500s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/10/2018 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021500s029lbl.pdf | |
04/07/2017 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021500s028,021896s025lbl.pdf | |
04/02/2013 | SUPPL-21 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021500s021,021896s018lbl.pdf | |
04/02/2013 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021500s021,021896s018lbl.pdf | |
07/23/2012 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021500s019lbl.pdf | |
07/23/2012 | SUPPL-19 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021500s019lbl.pdf | |
11/18/2011 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021500s018,021896s015lbl.pdf | |
04/04/2008 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021500s010,021896s004lbl.pdf | |
12/22/2006 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021896s001,021500s007lbl.pdf | |
12/02/2005 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021500s003lbl.pdf | |
07/02/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21500_emtriva_lbl.pdf |
EMTRIVA
CAPSULE;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EMTRICITABINE | EMTRICITABINE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 079188 | AUROBINDO PHARMA LTD |
EMTRICITABINE | EMTRICITABINE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 091168 | CIPLA |
EMTRIVA | EMTRICITABINE | 200MG | CAPSULE;ORAL | Prescription | Yes | AB | 021500 | GILEAD |