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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DIDRONEL ETIDRONATE DISODIUM 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
DIDRONEL ETIDRONATE DISODIUM 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/01/1977 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017831s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017831Orig1s058ltr.pdf
03/18/2015 SUPPL-57 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017831s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017831Orig1s057ltr.pdf
04/19/2013 SUPPL-56 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017831s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017831Orig1s056ltr.pdf
12/31/2009 SUPPL-55 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017831s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017831s055ltr.pdf
01/09/2006 SUPPL-54 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017831s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017831s054ltr.pdf
02/25/2004 SUPPL-53 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17831slr053_didronel_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17831slr053ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/017831_S053_DIDRONEL_AP.pdf
03/15/2002 SUPPL-52 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17831s52ltr.pdf
06/18/1997 SUPPL-51 Labeling

Label is not available on this site.
06/16/1997 SUPPL-50 Labeling

Label is not available on this site.
10/04/1996 SUPPL-49 Labeling

Label is not available on this site.
02/29/1996 SUPPL-48 Labeling

Label is not available on this site.
02/27/1996 SUPPL-46 Labeling

Label is not available on this site.
05/05/1994 SUPPL-44 Labeling

Label is not available on this site.
09/28/1993 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.
06/07/1993 SUPPL-42 Labeling

Label is not available on this site.
07/05/1989 SUPPL-38 Labeling

Label is not available on this site.
08/02/1988 SUPPL-37 Labeling

Label is not available on this site.
09/23/1988 SUPPL-36 Labeling

Label is not available on this site.
03/01/1988 SUPPL-35 Labeling

Label is not available on this site.
07/10/1986 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.
03/24/1986 SUPPL-33 Labeling

Label is not available on this site.
07/10/1986 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.
01/07/1986 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.
01/07/1986 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.
07/06/1984 SUPPL-29 Labeling

Label is not available on this site.
07/06/1984 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.
01/08/1983 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
01/11/1983 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
01/11/1983 SUPPL-18 Labeling

Label is not available on this site.
08/25/1982 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
09/08/1982 SUPPL-15 Labeling

Label is not available on this site.
08/04/1981 SUPPL-13 Labeling

Label is not available on this site.
10/01/1980 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/14/1980 SUPPL-11 Labeling

Label is not available on this site.
12/13/1979 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
08/25/1980 SUPPL-9 Efficacy

Label is not available on this site.
01/23/1979 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
01/23/1979 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
01/23/1979 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
01/23/1979 SUPPL-4 Efficacy

Label is not available on this site.
01/11/1978 SUPPL-1 Labeling

Label is not available on this site.

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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