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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076584
Company: RISING

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
01/31/2023 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
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 REMS-Proposal, Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.
05/04/2011 SUPPL-5 Labeling-Package Insert, Labeling-Container/Carton Labels

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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