Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019951
Company: VIIV HLTHCARE

Products on NDA 19951

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RETROVIR	ZIDOVUDINE	10MG/ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Labels for NDA 019951

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/11/2024	SUPPL-39	Manufacturing (CMC)-Manufacturing Process	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019951Orig1s039lbl.pdf
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-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019655s058,019910s045,019951s036lbl.pdf
09/10/2018	SUPPL-36	Labeling-Package Insert	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