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U.S. Department of Health and Human Services

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PDUFA FY 2004 Manufacturing Supplements Filed

The total number of manufacturing supplements filed was 2,025 in FY 2000 representing 1,438 NDAs and 587 BLAs. The total number of manufacturing supplements increased to 2,065 in FY 2001 representing 1,474 NDAs and 591 BLAs. The total number of manufacturing supplements significantly increased to 2,476 in FY 2002 representing 1,759 NDAs and 717 BLAs. The total number of manufacturing supplements increased again to 2,598 in FY 2003 representing 1,696 NDAs and 902 BLAs. The total number of manufacturing supplements dropped to 2,481 in FY 2004 representing 1,616 NDAs and 865 BLAs.

 

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