美国FDA药品橙皮书数据库
(U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations)
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
LIVMARLI 219485 003 NDA MARALIXIBAT CHLORIDE TABLET;ORAL EQ 20MG BASE Yes No 2025/04/10 MIRUM RX 详细信息
LIVMARLI 219485 004 NDA MARALIXIBAT CHLORIDE TABLET;ORAL EQ 30MG BASE Yes Yes 2025/04/10 MIRUM RX 详细信息
LIVTENCITY 215596 001 NDA MARIBAVIR TABLET;ORAL 200MG Yes Yes 2021/11/23 TAKEDA PHARMS USA RX 详细信息
LO LOESTRIN FE 022501 001 NDA ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.01MG,0.01MG;1MG,N/A Yes Yes 2010/10/21 APIL RX 详细信息
LO SIMPESSE 206852 001 ANDA ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL 0.02MG,0.1MG;0.01MG,N/A No No AB 2017/04/28 AUROBINDO PHARMA RX 详细信息
LO-TROL 088009 001 ANDA ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL 0.025MG;2.5MG No No 1983/03/25 VANGARD DISCN 详细信息
LO-ZUMANDIMINE 209632 001 ANDA DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL 3MG;0.02MG No No AB 2018/02/27 AUROBINDO PHARMA LTD RX 详细信息
LODINE 018922 004 NDA ETODOLAC TABLET;ORAL 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1993/07/29 WYETH PHARMS INC DISCN 详细信息
LODINE 018922 005 NDA ETODOLAC TABLET;ORAL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1996/06/28 WYETH PHARMS INC DISCN 详细信息
LODOCO 215727 001 NDA COLCHICINE TABLET;ORAL 0.5MG Yes Yes 2023/06/16 AGEPHA PHARMA FZ RX 详细信息
LODOSYN 017830 001 NDA CARBIDOPA TABLET;ORAL 25MG Yes Yes AB Approved Prior to Jan 1, 1982 ATON RX 详细信息
LOESTRIN 24 FE 021871 001 NDA ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2006/02/17 TEVA BRANDED PHARM DISCN 详细信息
LOFEXIDINE HYDROCHLORIDE 218699 001 ANDA LOFEXIDINE HYDROCHLORIDE TABLET;ORAL EQ 0.18MG BASE No No AB 2025/02/24 MSN RX 详细信息
LOFEXIDINE HYDROCHLORIDE 219917 001 ANDA LOFEXIDINE HYDROCHLORIDE TABLET;ORAL EQ 0.18MG BASE No No AB 2025/10/22 NOVITIUM PHARMA RX 详细信息
LOFEXIDINE HYDROCHLORIDE 218613 001 ANDA LOFEXIDINE HYDROCHLORIDE TABLET;ORAL EQ 0.18MG BASE No No AB 2024/08/20 REGCON HOLDINGS RX 详细信息
LOGEN 088962 001 ANDA ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL 0.025MG;2.5MG No No 1985/05/10 SUPERPHARM DISCN 详细信息
LOGILIA 207952 001 ANDA ULIPRISTAL ACETATE TABLET;ORAL 30MG No No AB 2017/02/13 TEVA PHARMS USA RX 详细信息
LOMAIRA 203495 001 ANDA PHENTERMINE HYDROCHLORIDE TABLET;ORAL 8MG No Yes AA 2016/09/12 AVANTHI INC RX 详细信息
LOMOTIL 012462 001 NDA ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL 0.025MG;2.5MG Yes Yes AA Approved Prior to Jan 1, 1982 PFIZER RX 详细信息
LONITEN 018154 001 NDA MINOXIDIL TABLET;ORAL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 PFIZER DISCN 详细信息
当前数据更新日期:2026年04月04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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