Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020978
Company: VIIV HLTHCARE
Company: VIIV HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZIAGEN | ABACAVIR SULFATE | EQ 20MG BASE/ML | SOLUTION;ORAL | Prescription | AA | 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 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 11/24/2020 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020977s035,020978s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020977Orig1s035;020978Orig1s038ltr.pdf | |
| 05/09/2018 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020977s033s034,020978s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020977Orig1s033s034,020978Orig1s036s037ltr.pdf | |
| 05/09/2018 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020977s033s034,020978s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020977Orig1s033s034,020978Orig1s036s037ltr.pdf | |
| 03/20/2017 | SUPPL-35 | 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-34 | 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 | |
| 02/19/2015 | SUPPL-32 | 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-31 | 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-30 | 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-29 | 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-28 | 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-27 | 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-26 | 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-24 | 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-22 | Labeling |
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-20 | 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-19 | 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-16 | 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/2006/020978_S016_ZIAGEN.pdf | |
| 07/26/2004 | SUPPL-15 | 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-14 | 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/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s012,20978s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020978_S014_ZIAGEN.pdf | |
| 04/15/2004 | SUPPL-13 | 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-12 | 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-10 | 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 | |
| 12/24/2002 | SUPPL-9 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020978_S009_ZIAGEN.pdf |
| 10/02/2002 | SUPPL-8 | 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-7 | Labeling |
Label is not available on this site. |
||
| 01/28/2002 | SUPPL-6 | 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-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/27/2000 | SUPPL-4 | 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/2000/20-978S-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 |
|---|---|---|---|---|---|
| 11/24/2020 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020977s035,020978s038lbl.pdf | |
| 05/09/2018 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020977s033s034,020978s036s037lbl.pdf | |
| 05/09/2018 | SUPPL-36 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020977s033s034,020978s036s037lbl.pdf | |
| 05/09/2018 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020977s033s034,020978s036s037lbl.pdf | |
| 03/20/2017 | SUPPL-35 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020977s032,020978s035lbl.pdf | |
| 03/20/2017 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020977s032,020978s035lbl.pdf | |
| 09/30/2015 | SUPPL-34 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s030,020978s034lbl.pdf | |
| 09/30/2015 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s030,020978s034lbl.pdf | |
| 03/23/2015 | SUPPL-31 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s027,020978s031lbl.pdf | |
| 02/19/2015 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s028,020978s032lbl.pdf | |
| 09/11/2013 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020977s026,020978s030lbl.pdf | |
| 05/18/2012 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s025,020978s029lbl.pdf | |
| 03/15/2012 | SUPPL-28 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s024,020978s028lbl.pdf | |
| 11/18/2011 | SUPPL-27 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020977s023,020978s027lbl.pdf | |
| 12/19/2008 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s019,020978s022lbl.pdf | |
| 07/18/2008 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s017,020978s020lbl.pdf | |
| 05/07/2007 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020977s016,020978s019lbl.pdf | |
| 08/11/2006 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020977s014,020978s016lbl.pdf | |
| 08/02/2004 | SUPPL-14 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s012,20978s014lbl.pdf | |
| 07/26/2004 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s013,20978s015lbl.pdf | |
| 04/15/2004 | SUPPL-13 | 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-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20978slr012,20977slr010_ziagen_lbl.pdf | |
| 10/02/2002 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s7,20978s8lbl.pdf | |
| 08/14/2002 | SUPPL-10 | 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
SOLUTION;ORAL; EQ 20MG BASE/ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABACAVIR SULFATE | ABACAVIR SULFATE | EQ 20MG BASE/ML | SOLUTION;ORAL | Prescription | No | AA | 077950 | AUROBINDO PHARMA LTD |
| ABACAVIR SULFATE | ABACAVIR SULFATE | EQ 20MG BASE/ML | SOLUTION;ORAL | Prescription | No | AA | 201107 | HETERO LABS LTD III |
| ZIAGEN | ABACAVIR SULFATE | EQ 20MG BASE/ML | SOLUTION;ORAL | Prescription | Yes | AA | 020978 | VIIV HLTHCARE |