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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019643
Company: MERCK

Tracked Changes Label

Products on NDA 19643

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEVACOR	LOVASTATIN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
MEVACOR	LOVASTATIN	20MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
MEVACOR	LOVASTATIN	40MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 019643

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/27/2014	SUPPL-88	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019643s088lbl.pdf
10/31/2012	SUPPL-87	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s086087lbl.pdf
10/31/2012	SUPPL-86	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s086087lbl.pdf
02/28/2012	SUPPL-85	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085lbl.pdf
02/02/2011	SUPPL-84	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019643s084lbl.pdf
06/30/2010	SUPPL-81	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019643s081lbl.pdf
03/09/2009	SUPPL-80	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019643s080lbl.pdf
03/09/2009	SUPPL-80	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019643s080lbl.pdf
05/29/2007	SUPPL-78	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019643s078lbl.pdf
04/17/2007	SUPPL-61	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019643s061lbl.pdf
11/04/2005	SUPPL-76	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019643s076lbl.pdf
06/13/2005	SUPPL-77	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019643s077lbl.pdf
04/07/2005	SUPPL-75	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19643s075lbl.pdf
09/20/2002	SUPPL-71	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19643s71lbl.pdf
02/14/2002	SUPPL-67	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19643s067lbl.pdf
10/22/2001	SUPPL-69	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19643s69lbl.pdf
04/26/2001	SUPPL-64	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19643s64lbl.pdf

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