Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019951
Company: VIIV HLTHCARE
Company: VIIV HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RETROVIR | ZIDOVUDINE | 10MG/ML | INJECTABLE;INJECTION | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 02/02/1990 | 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 |
|---|---|---|---|---|---|
| 06/18/2020 | SUPPL-37 | 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-36 | 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-35 | 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-34 | 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-33 | 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-32 | 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 | |
| 12/19/2013 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/2012 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019951s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019951s030ltr.pdf | |
| 11/18/2011 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019951s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019951s029ltr.pdf | |
| 11/15/2006 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019951s024ltr.pdf |
| 07/10/2006 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019951s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019951s023LTR.pdf | |
| 08/19/2002 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/2003 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19951slr019_retrovir_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19951slr019ltr.pdf | |
| 07/25/2003 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19951slr018_retrovir_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19951slr018ltr.pdf | |
| 02/21/2002 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19951s17ltr.pdf |
| 09/12/2001 | SUPPL-16 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19951s16lbl.pdf | |
| 02/01/2000 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1998 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/18/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/02/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/22/1996 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/20/1995 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/06/1995 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/07/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/08/1994 | SUPPL-3 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/07/1992 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
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-37 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019655Orig1s059,019910Orig1s046,019951Orig1s037lbl.pdf | |
| 06/18/2020 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019655Orig1s059,019910Orig1s046,019951Orig1s037lbl.pdf | |
| 09/10/2018 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019655s058,019910s045,019951s036lbl.pdf | |
| 09/10/2018 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019655s058,019910s045,019951s036lbl.pdf | |
| 11/28/2017 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s057,019910s044,019951s035lbl.pdf | |
| 04/10/2017 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s056,019910s043,019951s034lbl.pdf | |
| 02/24/2017 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s055,019910s042,019951s033lbl.pdf | |
| 12/23/2014 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf | |
| 05/31/2012 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019951s030lbl.pdf | |
| 11/18/2011 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019951s029lbl.pdf | |
| 07/10/2006 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019951s023lbl.pdf | |
| 07/29/2003 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19951slr019_retrovir_lbl.pdf | |
| 07/25/2003 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19951slr018_retrovir_lbl.pdf | |
| 09/12/2001 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19951s16lbl.pdf |