Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074419
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZATHIOPRINE SODIUM AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/31/1995 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
03/24/2014 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

08/09/2012 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

07/27/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

11/30/2000 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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