Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019384
Company: MERCK

• Medication Guide

• Medication Guide

Products on NDA 19384

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NOROXIN	NORFLOXACIN	400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 019384

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2016	SUPPL-67	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019384s067lbl.pdf
08/14/2013	SUPPL-66	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019384s066lbl.pdf
03/27/2013	SUPPL-65	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019384s065lbl.pdf
06/15/2012	SUPPL-63	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019384s063lbl.pdf
02/09/2012	SUPPL-62	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019384s062lbl.pdf
10/18/2011	SUPPL-60	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s060lbl.pdf
09/16/2011	SUPPL-61	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s061lbl.pdf
02/25/2011	SUPPL-56	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s056lbl.pdf
04/27/2009	SUPPL-54	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019384s054lbl.pdf
04/27/2009	SUPPL-54	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019384s054lbl.pdf
10/03/2008	SUPPL-52	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019384s052lbl.pdf
09/23/2008	SUPPL-50	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019384s049s050lbl.pdf
09/22/2006	SUPPL-46	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019384s046lbl.pdf
05/16/2006	SUPPL-45	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019384s045lbl.pdf
07/23/2004	SUPPL-43	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf
07/23/2004	SUPPL-42	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf
07/23/2004	SUPPL-40	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf