Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076184
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE TABLET;ORAL Discontinued None No No
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 35MG 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
02/06/2008 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/076184s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/076184_original_approval_pkg.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/01/2012 SUPPL-5 Labeling-Medication Guide, REMS-Proposal, Labeling-Package Insert

Label is not available on this site.

09/10/2009 SUPPL-4 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

08/04/2008 SUPPL-3 Labeling

Label is not available on this site.

08/04/2008 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/2008 SUPPL-1 Labeling

Label is not available on this site.

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