Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019951
Company: VIIV HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RETROVIR ZIDOVUDINE 10MG/ML INJECTABLE;INJECTION Prescription AP 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
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
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

RETROVIR

INJECTABLE;INJECTION; 10MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RETROVIR ZIDOVUDINE 10MG/ML INJECTABLE;INJECTION Prescription Yes AP 019951 VIIV HLTHCARE
ZIDOVUDINE ZIDOVUDINE 10MG/ML INJECTABLE;INJECTION Prescription No AP 091457 LUITPOLD

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