Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075874
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IFOSFAMIDE/MESNA KIT IFOSFAMIDE; MESNA 1GM/20ML;1GM/10ML (50MG/ML;100MG/ML) INJECTABLE;INTRAVENOUS Discontinued None No No
IFOSFAMIDE/MESNA KIT IFOSFAMIDE; MESNA 3GM/60ML;1GM/10ML (50MG/ML;100MG/ML) INJECTABLE;INTRAVENOUS 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
02/26/2002 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
05/26/2015 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

05/26/2015 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

05/26/2015 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

03/21/2011 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

01/17/2003 SUPPL-6 Labeling

Label is not available on this site.

12/13/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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