Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200477
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Discontinued None No No
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Discontinued None No No
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Discontinued None No No
RISEDRONATE SODIUM RISEDRONATE SODIUM 75MG TABLET;ORAL Discontinued None No No
RISEDRONATE SODIUM RISEDRONATE SODIUM 150MG 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
11/30/2015 ORIG-2 Approval Not Applicable

Label is not available on this site.

06/10/2014 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2015 SUPPL-2 Labeling-Medication Guide

Label is not available on this site.

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