Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017831
Company: APIL

• Other Important Information from FDA

Products on NDA 17831

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIDRONEL	ETIDRONATE DISODIUM	200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
DIDRONEL	ETIDRONATE DISODIUM	400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No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 017831

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/08/2015	SUPPL-58	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017831s058lbl.pdf
03/18/2015	SUPPL-57	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017831s057lbl.pdf
04/19/2013	SUPPL-56	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017831s056lbl.pdf
12/31/2009	SUPPL-55	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017831s055lbl.pdf
01/09/2006	SUPPL-54	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017831s054lbl.pdf
02/25/2004	SUPPL-53	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17831slr053_didronel_lbl.pdf