Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019655
Company: VIIV HLTHCARE
Company: VIIV HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RETROVIR | ZIDOVUDINE | 100MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 03/19/1987 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/18/2020 | SUPPL-59 | 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-58 | 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-57 | 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-56 | Labeling-Package Insert, Labeling-Patient 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-55 | 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-54 | 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-53 | 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-52 | 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-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019655s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019655s049,019910s036,020518s019ltr.pdf | |
| 11/06/2009 | SUPPL-48 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019655s048,020518s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019655s048,020518s018ltr.pdf | |
| 09/19/2008 | SUPPL-46 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033,019655s046,020518s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019910s033, 019655s046, 020518s016ltr.pdf | |
| 11/15/2006 | SUPPL-43 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019655s043ltr.pdf | |
| 05/10/2006 | SUPPL-41 | 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-39 | 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-38 | 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-37 | 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-36 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19655s36lbl.pdf | |
| 02/01/2000 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1999 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1998 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/30/2001 | SUPPL-32 | 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.cfm | |
| 11/04/1997 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1998 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 10/04/1996 | SUPPL-29 | Efficacy-New Indication |
Label is not available on this site. |
||
| 07/20/1995 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 10/04/1996 | SUPPL-26 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 02/06/1995 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/07/1994 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 08/08/1994 | SUPPL-23 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/24/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/08/1994 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 05/02/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/30/1990 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/12/1990 | SUPPL-13 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 08/24/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/02/1990 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/13/1989 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/06/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1988 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/24/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/21/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/18/2020 | SUPPL-59 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019655Orig1s059,019910Orig1s046,019951Orig1s037lbl.pdf | |
| 06/18/2020 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019655Orig1s059,019910Orig1s046,019951Orig1s037lbl.pdf | |
| 09/10/2018 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019655s058,019910s045,019951s036lbl.pdf | |
| 09/10/2018 | SUPPL-58 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019655s058,019910s045,019951s036lbl.pdf | |
| 11/28/2017 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s057,019910s044,019951s035lbl.pdf | |
| 04/10/2017 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s056,019910s043,019951s034lbl.pdf | |
| 04/10/2017 | SUPPL-56 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s056,019910s043,019951s034lbl.pdf | |
| 02/24/2017 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s055,019910s042,019951s033lbl.pdf | |
| 12/23/2014 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf | |
| 05/31/2012 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019655s053,019910s040,020518s023lbl.pdf | |
| 11/18/2011 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019655s052,019910s039,020518s022lbl.pdf | |
| 05/17/2010 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019655s049lbl.pdf | |
| 11/06/2009 | SUPPL-48 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019655s048,020518s018lbl.pdf | |
| 09/19/2008 | SUPPL-46 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033,019655s046,020518s016lbl.pdf | |
| 11/15/2006 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s043lbl.pdf | |
| 05/10/2006 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s41,019910s29,020518s13lbl.pdf | |
| 10/15/2003 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19655slr039,19910slr027,20528slr011_retrovir_lbl.pdf | |
| 12/18/2002 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20518slr010,19910slr026,19655slr038_retrovir_lbl.pdf | |
| 10/05/2001 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19655s36lbl.pdf | |
| 03/30/2001 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20518S4lbl.pdf |
RETROVIR
CAPSULE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RETROVIR | ZIDOVUDINE | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 019655 | VIIV HLTHCARE |
| ZIDOVUDINE | ZIDOVUDINE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 078128 | AUROBINDO PHARMA LTD |
| ZIDOVUDINE | ZIDOVUDINE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 078349 | CIPLA LTD |