Action Type | Duplicate Counter | Action Date | Document Type | Application Document ID | Sequence Number | Document Title | Document URL | Document Date |
AP | 0 | 12/17/1998 | N | 2066 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20978ltr.pdf
| 12/17/1998 |
AP | 0 | 12/17/1998 | N | 2067 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20978lbl.pdf
| 12/17/1998 |
AP | 0 | 12/17/1998 | N | 2068 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-977_Ziagen.cfm
| 12/17/1998 |
AP | 0 | 12/17/1998 | N | 7236 | 000 | |
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094302.htm
| 12/12/2003 |
AP | 0 | 12/17/1998 | N | 15921 | 000 | |
http://www.fda.gov/downloads/Drugs/DrugSafety/ucm224556.pdf
| 2/28/2007 |
AP | 0 | 4/20/2000 | SLR | | | |
| |
AP | 0 | 12/15/2000 | SE8 | 7267 | 002 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20978s2medguide.pdf
| 12/17/2003 |
AP | 0 | 12/15/2000 | SE8 | 8341 | 002 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-978S-002_review.pdf
| 4/14/2004 |
AP | 0 | 7/27/2000 | SLR | | | |
| |
AP | 0 | 7/13/2001 | SCS | | | |
| |
AP | 0 | 1/28/2002 | SLR | 2064 | 006 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20978s6ltr.pdf
| 1/28/2002 |
AP | 0 | 6/4/2002 | SLR | | | |
| |
AP | 0 | 10/2/2002 | SLR | 2061 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr007,20978slr008ltr.pdf
| 10/2/2002 |
AP | 0 | 10/2/2002 | SLR | 2062 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s7,20978s8lbl.pdf
| 10/2/2002 |
AP | 0 | 12/24/2002 | SCM | 18088 | 009 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020978_S009_ZIAGEN.pdf
| 9/26/2007 |
AP | 0 | 8/14/2002 | SLR | 2057 | 010 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr008,20978slr010ltr.pdf
| 8/14/2002 |
AP | 0 | 8/14/2002 | SLR | 2058 | 010 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s8lbl.pdf
| 8/14/2002 |
AP | 0 | 7/17/2003 | SLR | 6170 | 012 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20977slr010,20978slr012ltr.pdf
| 7/28/2003 |
AP | 0 | 7/17/2003 | SLR | 6689 | 012 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20978slr012,20977slr010_ziagen_lbl.pdf
| 9/25/2003 |
AP | 0 | 4/15/2004 | SE7 | 8364 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977se7-011,20978se7-013ltr.pdf
| 4/20/2004 |
AP | 0 | 4/15/2004 | SE7 | 8467 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977se7-011,20978se7-013_ziagen_lbl.pdf
| 5/3/2004 |
AP | 0 | 4/15/2004 | SE7 | 23223 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf
| 8/25/2009 |
AP | 1 | 4/15/2004 | SO | 8364 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977se7-011,20978se7-013ltr.pdf
| 4/20/2004 |
AP | 1 | 4/15/2004 | SO | 8467 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977se7-011,20978se7-013_ziagen_lbl.pdf
| 5/3/2004 |
AP | 1 | 4/15/2004 | SO | 23223 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf
| 8/25/2009 |
AP | 0 | 8/2/2004 | SE2 | 9941 | 014 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s012,20978s014ltr.pdf
| 8/5/2004 |
AP | 0 | 8/2/2004 | SE2 | 9942 | 014 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s012,20978s014lbl.pdf
| 8/5/2004 |
AP | 0 | 8/2/2004 | SE2 | 18087 | 014 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020978_S014_ZIAGEN.pdf
| 9/26/2007 |
AP | 0 | 8/2/2004 | SE2 | 23222 | 014 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf
| 8/25/2009 |
AP | 1 | 8/2/2004 | SO | 9941 | 014 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s012,20978s014ltr.pdf
| 8/5/2004 |
AP | 1 | 8/2/2004 | SO | 9942 | 014 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s012,20978s014lbl.pdf
| 8/5/2004 |
AP | 1 | 8/2/2004 | SO | 18087 | 014 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020978_S014_ZIAGEN.pdf
| 9/26/2007 |
AP | 1 | 8/2/2004 | SO | 23222 | 014 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf
| 8/25/2009 |
AP | 0 | 7/26/2004 | SLR | 9855 | 015 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s013,20978s015ltr.pdf
| 7/28/2004 |
AP | 0 | 7/26/2004 | SLR | 9877 | 015 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s013,20978s015lbl.pdf
| 7/28/2004 |
AP | 0 | 8/11/2006 | SLR | 14684 | 016 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020977s014,020978s016lbl.pdf
| 8/14/2006 |
AP | 0 | 8/11/2006 | SLR | 14734 | 016 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020977s014, 020978s016LTR.pdf
| 8/21/2006 |
AP | 0 | 8/11/2006 | SLR | 18086 | 016 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020978_S016_ZIAGEN.pdf
| 9/26/2007 |
AP | 0 | 5/7/2007 | SLR | 16473 | 019 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020977s016,020978s019lbl.pdf
| 5/9/2007 |
AP | 0 | 5/7/2007 | SLR | 16480 | 019 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020977s016, 020978s019ltr.pdf
| 5/9/2007 |
AP | 0 | 7/18/2008 | SE8 | 20267 | 020 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s017,020978s020lbl.pdf
| 7/22/2008 |
AP | 0 | 7/18/2008 | SE8 | 20276 | 020 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s017,020978s020ltr.pdf
| 7/23/2008 |
AP | 0 | 12/19/2008 | SLR | 21415 | 022 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s019, 020978s022ltr.pdf
| 12/29/2008 |
AP | 0 | 12/19/2008 | SLR | 21448 | 022 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s019,020978s022lbl.pdf
| 1/2/2009 |
AP | 0 | 8/4/2010 | S | 26194 | 024 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020977s020,020978s024,021205s024,021652s011ltr.pdf
| 8/10/2010 |
AP | 0 | 5/13/2011 | SLR | 28846 | 026 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s022,020978s026,021205s028,021652s013ltr.pdf
| 5/17/2011 |
AP | 0 | 11/18/2011 | SLR | 30732 | 027 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s023,020978s027ltr.pdf
| 11/22/2011 |
AP | 0 | 11/18/2011 | SLR | 30751 | 027 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020977s023,020978s027lbl.pdf
| 11/22/2011 |
AP | 0 | 3/15/2012 | SLR | 32134 | 028 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s024,020978s028lbl.pdf
| 3/16/2012 |
AP | 0 | 3/15/2012 | SLR | 32147 | 028 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s024,020978s028ltr.pdf
| 3/19/2012 |
AP | 0 | 5/18/2012 | SLR | 32728 | 029 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s025,020978s029lbl.pdf
| 5/22/2012 |
AP | 0 | 5/18/2012 | SLR | 32748 | 029 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s025,020978s029ltr.pdf
| 5/22/2012 |
AP | 0 | 9/11/2013 | SLR | 37084 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020977Orig1s026,020978Orig1s030ltr.pdf
| 9/13/2013 |
AP | 0 | 9/11/2013 | SLR | 37119 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020977s026,020978s030lbl.pdf
| 9/17/2013 |
AP | 0 | 3/23/2015 | SE8 | 42267 | 031 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s027,020978Orig1s031ltr.pdf
| 3/25/2015 |
AP | 0 | 3/23/2015 | SE8 | 42342 | 031 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s027,020978s031lbl.pdf
| 4/1/2015 |
AP | 0 | 2/19/2015 | SLR | 41881 | 032 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s028,020978s032lbl.pdf
| 2/20/2015 |
AP | 0 | 2/19/2015 | SLR | 41903 | 032 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s028,020978Orig1s032ltr.pdf
| 2/24/2015 |
AP | 0 | 9/30/2015 | SLR | 44087 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s030,020978Orig1s034ltr.pdf
| 10/2/2015 |
AP | 0 | 9/30/2015 | SLR | 44162 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s030,020978s034lbl.pdf
| 10/7/2015 |