Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021500
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-Patient Package Insert, Labeling-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-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021500s019lbl.pdf
07/23/2012 SUPPL-19 Labeling-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 091168 CIPLA
EMTRIVA EMTRICITABINE 200MG CAPSULE;ORAL Prescription Yes AB 021500 GILEAD

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