美国FDA药品橙皮书数据库
（U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations）
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数据记录共 48215 条，共 2411 页，当前第 27 页
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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 是否参比药物 是否生物等效参考标准 治疗等效代码 产品批准日期 申请人 市场状态 专利及市场独占权
PREDNISOLONE SODIUM PHOSPHATE 202179 001 ANDA PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 10MG BASE No No 2013/04/10 RISING DISCN 详细信息
PREDNISOLONE SODIUM PHOSPHATE 202179 002 ANDA PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 15MG BASE No No 2013/04/10 RISING DISCN 详细信息
PREDNISOLONE SODIUM PHOSPHATE 202179 003 ANDA PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 30MG BASE No No 2013/04/10 RISING DISCN 详细信息
PROPULSID QUICKSOLV 020767 001 NDA CISAPRIDE MONOHYDRATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 20MG BASE No No 1997/11/07 JANSSEN PHARMA DISCN 详细信息
QMIIZ ODT 211210 001 NDA MELOXICAM TABLET, ORALLY DISINTEGRATING;ORAL 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2018/10/19 TERSERA DISCN 详细信息
QMIIZ ODT 211210 002 NDA MELOXICAM TABLET, ORALLY DISINTEGRATING;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2018/10/19 TERSERA DISCN 详细信息
REGLAN ODT 021793 001 NDA METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL EQ 5MG BASE No No 2005/06/10 MEDA PHARMS DISCN 详细信息
REGLAN ODT 021793 002 NDA METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL EQ 10MG BASE No No 2005/06/10 MEDA PHARMS DISCN 详细信息
REMERON SOLTAB 021208 001 NDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Yes Yes AB 2001/01/12 ORGANON USA ORGANON RX 详细信息
REMERON SOLTAB 021208 002 NDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 30MG Yes No AB 2001/01/12 ORGANON USA ORGANON RX 详细信息
REMERON SOLTAB 021208 003 NDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 45MG Yes No AB 2001/01/12 ORGANON USA ORGANON RX 详细信息
RISPERDAL 021444 001 NDA RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2003/04/02 JANSSEN PHARMS DISCN 详细信息
RISPERDAL 021444 002 NDA RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2003/04/02 JANSSEN PHARMS DISCN 详细信息
RISPERDAL 021444 003 NDA RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2003/04/02 JANSSEN PHARMS DISCN 详细信息
RISPERDAL 021444 004 NDA RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2004/12/23 JANSSEN PHARMS DISCN 详细信息
RISPERDAL 021444 005 NDA RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2004/12/23 JANSSEN PHARMS DISCN 详细信息
RISPERIDONE 076996 001 ANDA RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 0.5MG No No 2011/04/19 ACTAVIS LABS FL INC DISCN 详细信息
RISPERIDONE 076996 002 ANDA RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 1MG No No 2011/04/19 ACTAVIS LABS FL INC DISCN 详细信息
RISPERIDONE 076996 003 ANDA RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 2MG No No 2011/04/19 ACTAVIS LABS FL INC DISCN 详细信息
RISPERIDONE 076996 004 ANDA RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 3MG No No 2011/04/19 ACTAVIS LABS FL INC DISCN 详细信息
当前数据更新日期：2026年05月23日，更多信息请点击此处查询美国FDA药品数据库
数据库说明：本数据与美国FDA官方药品橙皮书数据库同步，在官方数据基础上，提供更全面的检索方式和更简洁高效、完整的数据展现，并且可以回溯专利及市场独占权（市场排他数据）历史信息。
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