Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020977
Company: VIIV HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZIAGEN ABACAVIR SULFATE EQ 300MG BASE TABLET;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
12/17/1998 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20978lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20978ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-977_Ziagen.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/20/2017 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020977s032,020978s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020977Orig1s032,020978Orig1s035ltr.pdf
09/30/2015 SUPPL-30 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s030,020978s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s030,020978Orig1s034ltr.pdf
07/21/2015 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/19/2015 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s028,020978s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s028,020978Orig1s032ltr.pdf
03/23/2015 SUPPL-27 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s027,020978s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s027,020978Orig1s031ltr.pdf
09/11/2013 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020977s026,020978s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020977Orig1s026,020978Orig1s030ltr.pdf
05/18/2012 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s025,020978s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s025,020978s029ltr.pdf
03/15/2012 SUPPL-24 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s024,020978s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s024,020978s028ltr.pdf
11/18/2011 SUPPL-23 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020977s023,020978s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s023,020978s027ltr.pdf
05/13/2011 SUPPL-22 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s022,020978s026,021205s028,021652s013ltr.pdf
08/04/2010 SUPPL-20 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020977s020,020978s024,021205s024,021652s011ltr.pdf
12/19/2008 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s019,020978s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s019, 020978s022ltr.pdf
07/18/2008 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s017,020978s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s017,020978s020ltr.pdf
05/07/2007 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020977s016,020978s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020977s016, 020978s019ltr.pdf
08/11/2006 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020977s014,020978s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020977s014, 020978s016LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020977_S014_ZIAGEN.pdf
07/26/2004 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s013,20978s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s013,20978s015ltr.pdf
08/02/2004 SUPPL-12 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s012,20978s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s012,20978s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020977_S012_Ziagen.pdf
04/15/2004 SUPPL-11 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977se7-011,20978se7-013_ziagen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977se7-011,20978se7-013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf
07/17/2003 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20978slr012,20977slr010_ziagen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20977slr010,20978slr012ltr.pdf
08/14/2002 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr008,20978slr010ltr.pdf
10/02/2002 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s7,20978s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr007,20978slr008ltr.pdf
06/04/2002 SUPPL-6 Labeling

Label is not available on this site.

01/28/2002 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20978s6ltr.pdf
07/13/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/2000 SUPPL-3 Labeling

Label is not available on this site.

12/15/2000 SUPPL-2 Efficacy-Labeling Change With Clinical Data Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-977S-002_review.pdf
04/20/2000 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/20/2017 SUPPL-32 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020977s032,020978s035lbl.pdf
03/20/2017 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020977s032,020978s035lbl.pdf
09/30/2015 SUPPL-30 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s030,020978s034lbl.pdf
09/30/2015 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s030,020978s034lbl.pdf
03/23/2015 SUPPL-27 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s027,020978s031lbl.pdf
02/19/2015 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s028,020978s032lbl.pdf
09/11/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020977s026,020978s030lbl.pdf
05/18/2012 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s025,020978s029lbl.pdf
03/15/2012 SUPPL-24 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s024,020978s028lbl.pdf
11/18/2011 SUPPL-23 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020977s023,020978s027lbl.pdf
12/19/2008 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s019,020978s022lbl.pdf
07/18/2008 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s017,020978s020lbl.pdf
05/07/2007 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020977s016,020978s019lbl.pdf
08/11/2006 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020977s014,020978s016lbl.pdf
08/02/2004 SUPPL-12 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s012,20978s014lbl.pdf
07/26/2004 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s013,20978s015lbl.pdf
04/15/2004 SUPPL-11 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977se7-011,20978se7-013_ziagen_lbl.pdf
07/17/2003 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20978slr012,20977slr010_ziagen_lbl.pdf
10/02/2002 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s7,20978s8lbl.pdf
08/14/2002 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s8lbl.pdf
12/17/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20978lbl.pdf

ZIAGEN

TABLET;ORAL; EQ 300MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 201570 APOTEX INC
ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 077844 AUROBINDO PHARMA LTD
ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 091560 HETERO LABS LTD III
ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 091294 MYLAN PHARMS INC
ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 091050 STRIDES PHARMA
ZIAGEN ABACAVIR SULFATE EQ 300MG BASE TABLET;ORAL Prescription Yes AB 020977 VIIV HLTHCARE

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