Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076584
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 5MG BASE TABLET;ORAL Discontinued None No No
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 10MG BASE TABLET;ORAL Discontinued None No No
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 35MG BASE TABLET;ORAL Discontinued None No No
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE TABLET;ORAL Discontinued None No 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
08/04/2008 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/08/2016 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

07/16/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

07/16/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

10/17/2012 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

07/18/2013 SUPPL-9 Labeling-Container/Carton Labels

Label is not available on this site.

05/02/2011 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

05/04/2011 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/20/2009 SUPPL-3 Labeling-Container/Carton Labels

Label is not available on this site.

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