Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075871
Company: UPSHER-SMITH LABS
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 40MG 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
04/22/2009 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
02/25/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

02/25/2016 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/20/2015 SUPPL-1 Labeling-Medication Guide, REMS-Proposal, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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