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November 2008
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 091004).
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March 2008
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 090462).
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January 2008
Sigmapharm completes its 1st FDA inspection focused on its current GMP status and a Pre-Approval-Inspection related to its ANDA No. 079133.