Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017831
Company: APIL
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DIDRONEL ETIDRONATE DISODIUM 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
DIDRONEL ETIDRONATE DISODIUM 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
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

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