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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
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
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