Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019910
Company: VIIV HLTHCARE
Company: VIIV HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RETROVIR | ZIDOVUDINE | 50MG/5ML | 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 |
|---|---|---|---|---|---|---|---|
| 09/28/1989 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/18/2024 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019655Orig1s060;019910Orig1s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019655Orig1s060;019910Orig1s048ltr.pdf | |
| 06/18/2020 | SUPPL-46 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019655Orig1s059,019910Orig1s046,019951Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019655Orig1s059,019910Orig1s046,019951Orig1s037ltr.pdf | |
| 09/10/2018 | SUPPL-45 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019655s058,019910s045,019951s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019655Orig1s058,019910Orig1s045,019951Orig1s036ltr.pdf | |
| 11/28/2017 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s057,019910s044,019951s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019655Orig1s057,019910Orig1s044,019951Orig1s035ltr.pdf | |
| 04/10/2017 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s056,019910s043,019951s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019655Orig1s056,019910Orig1s043,019951Orig1s034ltr.pdf | |
| 02/24/2017 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s055,019910s042,019951s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019655Orig1s055,019910Orig1s042,019951Orig1s033ltr.pdf | |
| 12/23/2014 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019655Orig1s054,019910Orig1s041,019951Orig1s032,020518Orig1s024ltr.pdf | |
| 05/31/2012 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019655s053,019910s040,020518s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019655s053,019910s040,020518s023ltr.pdf | |
| 11/18/2011 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019655s052,019910s039,020518s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019655s052,019910s039,020518s022ltr.pdf | |
| 05/17/2010 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019910s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019655s049,019910s036,020518s019ltr.pdf | |
| 11/06/2009 | SUPPL-35 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019910s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019910s035ltr.pdf | |
| 09/19/2008 | SUPPL-33 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019910s033, 019655s046, 020518s016ltr.pdf | |
| 11/15/2006 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019910s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019910s032ltr.pdf | |
| 05/10/2006 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s41,019910s29,020518s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019655s041, 019910s029, 020518s013LTR.pdf | |
| 10/15/2003 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19655slr039,19910slr027,20528slr011_retrovir_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19655slr039,19910slr027,20528slr011ltr.pdf | |
| 12/18/2002 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20518slr010,19910slr026,19655slr038_retrovir_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20518slr010,19910slr026,19655slr038ltr.pdf | |
| 02/21/2002 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19655s37ltr.pdf |
| 10/05/2001 | SUPPL-24 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19910s24lbl.pdf | |
| 02/01/2000 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1999 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/2001 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20518S4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20518S4LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019655s032_019910s021_020518s004_Retrovir.html | |
| 02/25/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1998 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/04/1996 | SUPPL-18 | Efficacy-New Indication |
Label is not available on this site. |
||
| 07/20/1995 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 10/04/1996 | SUPPL-15 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 02/06/1995 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/07/1994 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/08/1994 | SUPPL-11 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/24/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/19/1992 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/08/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/02/1990 | SUPPL-4 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 01/12/1990 | SUPPL-3 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 05/02/1990 | SUPPL-2 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 05/25/1990 | 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 |
|---|---|---|---|---|---|
| 12/18/2024 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019655Orig1s060;019910Orig1s048lbl.pdf | |
| 06/18/2020 | SUPPL-46 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019655Orig1s059,019910Orig1s046,019951Orig1s037lbl.pdf | |
| 06/18/2020 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019655Orig1s059,019910Orig1s046,019951Orig1s037lbl.pdf | |
| 09/10/2018 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019655s058,019910s045,019951s036lbl.pdf | |
| 09/10/2018 | SUPPL-45 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019655s058,019910s045,019951s036lbl.pdf | |
| 11/28/2017 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s057,019910s044,019951s035lbl.pdf | |
| 04/10/2017 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s056,019910s043,019951s034lbl.pdf | |
| 02/24/2017 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s055,019910s042,019951s033lbl.pdf | |
| 12/23/2014 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf | |
| 05/31/2012 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019655s053,019910s040,020518s023lbl.pdf | |
| 11/18/2011 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019655s052,019910s039,020518s022lbl.pdf | |
| 05/17/2010 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019910s036lbl.pdf | |
| 11/06/2009 | SUPPL-35 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019910s035lbl.pdf | |
| 09/19/2008 | SUPPL-33 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033lbl.pdf | |
| 11/15/2006 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019910s032lbl.pdf | |
| 05/10/2006 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s41,019910s29,020518s13lbl.pdf | |
| 10/15/2003 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19655slr039,19910slr027,20528slr011_retrovir_lbl.pdf | |
| 12/18/2002 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20518slr010,19910slr026,19655slr038_retrovir_lbl.pdf | |
| 10/05/2001 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19910s24lbl.pdf | |
| 03/30/2001 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20518S4lbl.pdf |
RETROVIR
SOLUTION;ORAL; 50MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RETROVIR | ZIDOVUDINE | 50MG/5ML | SOLUTION;ORAL | Prescription | Yes | AA | 019910 | VIIV HLTHCARE |
| ZIDOVUDINE | ZIDOVUDINE | 50MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 077268 | AUROBINDO |
| ZIDOVUDINE | ZIDOVUDINE | 50MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 077981 | CIPLA LTD |