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
TACROLIMUS 217108 001 ANDA TACROLIMUS INJECTABLE;INJECTION EQ 5MG BASE/ML No No AP 2025/02/12 NEXUS RX 详细信息
TAGAMET 017939 002 NDA CIMETIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 300MG BASE/2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No Approved Prior to Jan 1, 1982 GLAXOSMITHKLINE DISCN 详细信息
TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 019434 001 NDA CIMETIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1985/10/31 GLAXOSMITHKLINE DISCN 详细信息
TALWIN 016194 001 NDA PENTAZOCINE LACTATE INJECTABLE;INJECTION EQ 30MG BASE/ML Yes No Approved Prior to Jan 1, 1982 HOSPIRA DISCN 详细信息
TARACTAN 012487 001 NDA CHLORPROTHIXENE INJECTABLE;INJECTION 12.5MG/ML No No Approved Prior to Jan 1, 1982 ROCHE DISCN 详细信息
TAXOL 020262 001 NDA PACLITAXEL INJECTABLE;INJECTION 6MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1992/12/29 HQ SPCLT PHARMA DISCN 详细信息
TAXOTERE 020449 003 NDA DOCETAXEL INJECTABLE;INJECTION 20MG/ML (20MG/ML) Yes No 2010/08/03 SANOFI AVENTIS US DISCN 详细信息
TAXOTERE 020449 001 NDA DOCETAXEL INJECTABLE;INJECTION 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1996/05/14 SANOFI AVENTIS US DISCN 详细信息
TAXOTERE 020449 004 NDA DOCETAXEL INJECTABLE;INJECTION 80MG/4ML (20MG/ML) Yes No 2010/08/02 SANOFI AVENTIS US DISCN 详细信息
TAXOTERE 020449 005 NDA DOCETAXEL INJECTABLE;INJECTION 160MG/8ML (20MG/ML) Yes No AP 2012/04/13 SANOFI AVENTIS US RX 详细信息
TAZICEF 062662 002 ANDA CEFTAZIDIME INJECTABLE;INJECTION 1GM/VIAL No No AP 1986/03/06 HOSPIRA RX 详细信息
TAZICEF 064032 001 ANDA CEFTAZIDIME INJECTABLE;INJECTION 1GM/VIAL No No AP 1993/10/31 HOSPIRA RX 详细信息
TAZICEF 062662 003 ANDA CEFTAZIDIME INJECTABLE;INJECTION 2GM/VIAL No No AP 1986/03/06 HOSPIRA RX 详细信息
TAZICEF 064032 002 ANDA CEFTAZIDIME INJECTABLE;INJECTION 2GM/VIAL No No AP 1993/10/31 HOSPIRA RX 详细信息
TAZICEF 062662 004 ANDA CEFTAZIDIME INJECTABLE;INJECTION 6GM/VIAL No No AP 1986/03/06 HOSPIRA RX 详细信息
TAZICEF 062662 001 ANDA CEFTAZIDIME INJECTABLE;INJECTION 500MG/VIAL No No 1986/03/06 HOSPIRA DISCN 详细信息
TAZIDIME 062655 001 ANDA CEFTAZIDIME INJECTABLE;INJECTION 1GM/VIAL No No 1985/11/20 LILLY DISCN 详细信息
TAZIDIME 062655 002 ANDA CEFTAZIDIME INJECTABLE;INJECTION 2GM/VIAL No No 1985/11/20 LILLY DISCN 详细信息
TAZIDIME IN PLASTIC CONTAINER 062739 001 ANDA CEFTAZIDIME INJECTABLE;INJECTION 1GM/VIAL No No 1986/07/10 LILLY DISCN 详细信息
TAZIDIME IN PLASTIC CONTAINER 062739 002 ANDA CEFTAZIDIME INJECTABLE;INJECTION 2GM/VIAL No No 1986/07/10 LILLY DISCN 详细信息
当前数据更新日期:2025年12月14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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