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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021500
Company: GILEAD

Products on NDA 021500

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMTRIVA	EMTRICITABINE	200MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021500

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-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-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

Labels for NDA 021500

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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021500s021,021896s018lbl.pdf
04/02/2013	SUPPL-21	Labeling-Patient 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

Therapeutic Equivalents for NDA 021500

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

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