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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020518
Company: VIIV HLTHCARE

Products on NDA 020518

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RETROVIR	ZIDOVUDINE	200MG	TABLET;ORAL	Discontinued	None	No	No
RETROVIR	ZIDOVUDINE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020518

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/1995	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2014	SUPPL-24	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-23	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-22	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-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020518s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019655s049,019910s036,020518s019ltr.pdf
11/06/2009	SUPPL-18	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-16	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
11/20/2006	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020518s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020518s015ltr.pdf
05/10/2006	SUPPL-13	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-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19655slr039,19910slr027,20518slr011_retrovir_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19655slr039,19910slr027,20518slr011ltr.pdf
12/18/2002	SUPPL-10	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-9	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-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20518s8lbl.pdf
02/01/2000	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
04/02/1999	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
02/26/1999	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/30/2001	SUPPL-4	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
06/12/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/04/1998	SUPPL-2	Labeling		Label is not available on this site.
10/04/1996	SUPPL-1	Manufacturing (CMC)-Formulation		Label is not available on this site.

Labels for NDA 020518

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2014	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf
05/31/2012	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019655s053,019910s040,020518s023lbl.pdf
11/18/2011	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019655s052,019910s039,020518s022lbl.pdf
05/17/2010	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020518s019lbl.pdf
11/06/2009	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019655s048,020518s018lbl.pdf
09/19/2008	SUPPL-16	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033,019655s046,020518s016lbl.pdf
11/20/2006	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020518s015lbl.pdf
05/10/2006	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s41,019910s29,020518s13lbl.pdf
10/15/2003	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19655slr039,19910slr027,20518slr011_retrovir_lbl.pdf
12/18/2002	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20518slr010,19910slr026,19655slr038_retrovir_lbl.pdf
10/05/2001	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20518s8lbl.pdf
03/30/2001	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20518S4lbl.pdf

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