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 47926 条，共 2397 页，当前第 8 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
LEVOXYL 021301 006 NDA LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1,AB3 2001/05/25 KING PHARMS RX 详细信息
LEVOXYL 021301 007 NDA LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1,AB3 2001/05/25 KING PHARMS RX 详细信息
LEVOXYL 021301 008 NDA LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1,AB3 2001/05/25 KING PHARMS RX 详细信息
LEVOXYL 021301 009 NDA LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1,AB3 2001/05/25 KING PHARMS RX 详细信息
LEVOXYL 021301 010 NDA LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1,AB3 2001/05/25 KING PHARMS RX 详细信息
LEVOXYL 021301 011 NDA LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes Yes AB1,AB3 2001/05/25 KING PHARMS RX 详细信息
LEVOXYL 021301 012 NDA LEVOTHYROXINE SODIUM TABLET;ORAL 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2001/05/25 KING PHARMS DISCN 详细信息
LEXAPRO 021323 001 NDA ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE Yes No AB 2002/08/14 ABBVIE RX 详细信息
LEXAPRO 021323 002 NDA ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE Yes No AB 2002/08/14 ABBVIE RX 详细信息
LEXAPRO 021323 003 NDA ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE Yes Yes AB 2002/08/14 ABBVIE RX 详细信息
LEXIVA 021548 001 NDA FOSAMPRENAVIR CALCIUM TABLET;ORAL EQ 700MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2003/10/20 VIIV HLTHCARE DISCN 详细信息
LIBRITABS 085482 001 ANDA CHLORDIAZEPOXIDE TABLET;ORAL 5MG No No Approved Prior to Jan 1, 1982 VALEANT PHARM INTL DISCN 详细信息
LIBRITABS 085481 001 ANDA CHLORDIAZEPOXIDE TABLET;ORAL 10MG No No Approved Prior to Jan 1, 1982 VALEANT PHARM INTL DISCN 详细信息
LIBRITABS 085488 001 ANDA CHLORDIAZEPOXIDE TABLET;ORAL 25MG No No Approved Prior to Jan 1, 1982 VALEANT PHARM INTL DISCN 详细信息
LIMBITROL 016949 001 NDA AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE TABLET;ORAL EQ 12.5MG BASE;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 CHARTWELL RX DISCN 详细信息
LIMBITROL DS 016949 002 NDA AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE TABLET;ORAL EQ 25MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 CHARTWELL RX DISCN 详细信息
LINAGLIPTIN 208415 001 ANDA LINAGLIPTIN TABLET;ORAL 5MG No No AB 2025/11/03 AUROBINDO PHARMA LTD RX 详细信息
LINAGLIPTIN 208428 001 ANDA LINAGLIPTIN TABLET;ORAL 5MG No No AB 2025/11/03 DR REDDYS RX 详细信息
LINAGLIPTIN 208423 001 ANDA LINAGLIPTIN TABLET;ORAL 5MG No No AB 2024/09/03 INVAGEN PHARMS RX 详细信息
LINAGLIPTIN 208457 001 ANDA LINAGLIPTIN TABLET;ORAL 5MG No No AB 2025/11/03 MSN RX 详细信息
当前数据更新日期：2026年04月03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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