Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021356
Company: GILEAD SCIENCES INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIREAD TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription AB Yes Yes
VIREAD TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET;ORAL Prescription AB Yes No
VIREAD TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET;ORAL Prescription AB Yes No
VIREAD TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET;ORAL Prescription AB Yes 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
10/26/2001 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21356lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21356ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-356_Viread.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/24/2019 SUPPL-58 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021356s058,022577s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021356Orig1s058,022577Orig1s014ltr.pdf
12/11/2018 SUPPL-57 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021356s057,022577s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021356Orig1s057, 022577Orig1s013ltr.pdf
07/30/2018 SUPPL-56 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021356s056,022577s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021356Orig1s056,022577Orig1s012ltr.pdf
04/07/2017 SUPPL-55 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021356s055,022577s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021356Orig1s055,022577Orig1s011ltr.pdf
03/10/2016 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

02/16/2016 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021356s052,022577s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021356Orig1s052,022577Orig1s009ltr.pdf
11/18/2015 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

05/29/2015 SUPPL-49 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021356s049,022577s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021356Orig1s049,022577Orig1s007ltr.pdf
10/23/2013 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s048,022577s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s048,022577Orig1s006ltr.pdf
04/02/2013 SUPPL-47 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s047,022577s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s047,022577Orig1s004ltr.pdf
07/24/2013 SUPPL-46 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s046,022577s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s046,022577Orig1s003ltr.pdf
03/12/2013 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

08/16/2012 SUPPL-42 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s042,022577s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021356Orig1s042,022577Orig1s002ltr.pdf
11/18/2011 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021356s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021356s041ltr.pdf
08/07/2012 SUPPL-40 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s040,022577s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021356Orig1s040,022577Orig1s001ltr.pdf
01/18/2012 SUPPL-38 Efficacy-Manufacturing Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021356s038ltr.pdf
09/19/2011 SUPPL-37 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021356s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021356s037ltr.pdf
10/14/2010 SUPPL-35 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021356s035ltr.pdf
10/01/2010 SUPPL-34 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021356s034ltr.pdf
03/24/2010 SUPPL-33 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021356s033ltr.pdf
01/15/2010 SUPPL-32 Labeling

Label is not available on this site.

11/10/2009 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021356s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021356s028ltr.pdf
10/07/2009 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021356s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021356s027ltr.pdf
11/04/2008 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021356s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021356s026ltr.pdf
08/11/2008 SUPPL-25 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021356s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021356s025ltr.pdf
05/16/2008 SUPPL-24 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021356s024ltr.pdf
05/21/2007 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021356s021,021752s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021356s021, 021752s011ltr.pdf
11/30/2005 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021356s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021356s017ltr.pdf
03/08/2006 SUPPL-16 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021356s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021356s016ltr.pdf
05/12/2005 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021356s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021356s011ltr.pdf
07/01/2004 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21356slr010_viread_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21356slr010ltr.pdf
10/31/2003 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356slr006_viread_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21356slr006ltr.pdf
10/14/2003 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356slr005_viread_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21356slr005ltr.pdf
08/15/2003 SUPPL-3 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356se5-003_viread_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21356se5-003ltr.pdf
12/02/2002 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21356slr001_Viread_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21356slr001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/24/2019 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021356s058,022577s014lbl.pdf
04/24/2019 SUPPL-58 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021356s058,022577s014lbl.pdf
12/11/2018 SUPPL-57 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021356s057,022577s013lbl.pdf
07/30/2018 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021356s056,022577s012lbl.pdf
04/07/2017 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021356s055,022577s011lbl.pdf
02/16/2016 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021356s052,022577s009lbl.pdf
05/29/2015 SUPPL-49 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021356s049,022577s007lbl.pdf
10/23/2013 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s048,022577s006lbl.pdf
07/24/2013 SUPPL-46 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s046,022577s003lbl.pdf
04/02/2013 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s047,022577s004lbl.pdf
04/02/2013 SUPPL-47 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s047,022577s004lbl.pdf
08/16/2012 SUPPL-42 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s042,022577s002lbl.pdf
08/07/2012 SUPPL-40 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s040,022577s001lbl.pdf
01/18/2012 SUPPL-38 Efficacy-Manufacturing Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s038lbl.pdf
11/18/2011 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021356s041lbl.pdf
09/19/2011 SUPPL-37 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021356s037lbl.pdf
10/14/2010 SUPPL-35 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s035lbl.pdf
10/01/2010 SUPPL-34 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s034lbl.pdf
03/24/2010 SUPPL-33 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s033lbl.pdf
11/10/2009 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021356s028lbl.pdf
10/07/2009 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021356s027lbl.pdf
11/04/2008 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021356s026lbl.pdf
08/11/2008 SUPPL-25 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021356s025lbl.pdf
05/21/2007 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021356s021,021752s011lbl.pdf
03/08/2006 SUPPL-16 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021356s016lbl.pdf
11/30/2005 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021356s017lbl.pdf
05/12/2005 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021356s011lbl.pdf
07/01/2004 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21356slr010_viread_lbl.pdf
10/31/2003 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356slr006_viread_lbl.pdf
10/14/2003 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356slr005_viread_lbl.pdf
08/15/2003 SUPPL-3 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356se5-003_viread_lbl.pdf
12/02/2002 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21356slr001_Viread_lbl.pdf
10/26/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21356lbl.pdf

VIREAD

TABLET;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 090647 AUROBINDO PHARMA LTD
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 209550 CASI PHARMS INC
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 078800 CIPLA
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 090636 HETERO LABS LTD III
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 203232 MACLEODS PHARMS LTD
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 206569 MYLAN
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 209498 QILU PHARM CO LTD
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 090742 STRIDES PHARMA
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 091612 TEVA PHARMS USA
VIREAD TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription Yes AB 021356 GILEAD SCIENCES INC

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET;ORAL Prescription No AB 090647 AUROBINDO PHARMA LTD
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET;ORAL Prescription No AB 206569 MYLAN
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET;ORAL Prescription No AB 091612 TEVA PHARMS USA
VIREAD TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET;ORAL Prescription Yes AB 021356 GILEAD SCIENCES INC

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET;ORAL Prescription No AB 090647 AUROBINDO PHARMA LTD
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET;ORAL Prescription No AB 206569 MYLAN
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET;ORAL Prescription No AB 209498 QILU PHARM CO LTD
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET;ORAL Prescription No AB 091612 TEVA PHARMS USA
VIREAD TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET;ORAL Prescription Yes AB 021356 GILEAD SCIENCES INC

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET;ORAL Prescription No AB 090647 AUROBINDO PHARMA LTD
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET;ORAL Prescription No AB 206569 MYLAN
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET;ORAL Prescription No AB 209498 QILU PHARM CO LTD
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET;ORAL Prescription No AB 091612 TEVA PHARMS USA
VIREAD TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET;ORAL Prescription Yes AB 021356 GILEAD SCIENCES INC

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