Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201689
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IFOSFAMIDE IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE;INJECTION Discontinued None No No
IFOSFAMIDE IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE;INJECTION 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
11/26/2012 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
09/21/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

09/21/2015 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/21/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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