美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ZENPEP"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
ZENPEP 022210 001 NDA PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL 24,000USP UNITS;5,000USP UNITS;17,000USP UNITS Yes No 2009/08/27 2009/08/27 FOREST LABS INC Prescription
ZENPEP 022210 002 NDA PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL 42,000USP UNITS;10,000USP UNITS;32,000USP UNITS Yes No 2009/08/27 2009/08/27 FOREST LABS INC Prescription
ZENPEP 022210 003 NDA PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL 63,000USP UNITS;15,000USP UNITS;47,000USP UNITS Yes No 2009/08/27 2009/08/27 FOREST LABS INC Prescription
ZENPEP 022210 004 NDA PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL 84,000USP UNITS;20,000USP UNITS;63,000USP UNITS Yes No 2009/08/27 2009/08/27 FOREST LABS INC Prescription
ZENPEP 022210 005 NDA PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL 14,000USP UNITS;3,000USP UNITS;10,000USP UNITS Yes No 2009/08/27 2011/06/15 FOREST LABS INC Prescription
ZENPEP 022210 006 NDA PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL 105,000USP UNITS;25,000USP UNITS;79,000USP UNITS Yes Yes 2009/08/27 2011/07/13 FOREST LABS INC Prescription
ZENPEP 022210 007 NDA PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL 168,000USP UNITS;40,000USP UNITS;126,000USP UNITS Yes No 2009/08/27 2014/03/25 FOREST LABS INC Prescription
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