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Approvals by Year Since 1996 1996, 1997, 1998, 1999, 2000, 2001, 2002, 2003, 2004 Product / Manufacturer Lists Licensed Products and Establishments New Drug Applications Approved Since 1990 Substantially Equivalent 510(k) Devices Since 1996 Premarket Approval Devices Since 1996 510(k) Blood Establishment Computer Software HIV, HTLV and Hepatitis Tests Approval Documents Licensed Products New Drug Applications Substantially Equivalent 510(k) Devices Premarket Approval Devices Product Labeling Transfer of Therapeutic Products to CDER

Updated July 13, 2004

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