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 46588 条，共 2330 页，当前第 3 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
TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE 091329 001 ANDA TRIMETHOBENZAMIDE HYDROCHLORIDE INJECTABLE;INJECTION 100MG/ML No No 2011/03/08 AM REGENT DISCN 详细信息
TRIOSTAT 020105 001 NDA LIOTHYRONINE SODIUM INJECTABLE;INJECTION EQ 0.01MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1991/12/31 ENDO OPERATIONS DISCN 详细信息
TRISENOX 021248 001 NDA ARSENIC TRIOXIDE INJECTABLE;INJECTION 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2000/09/25 CEPHALON DISCN 详细信息
TRISENOX 021248 002 NDA ARSENIC TRIOXIDE INJECTABLE;INJECTION 2MG/ML Yes Yes AP 2017/10/13 CEPHALON RX 详细信息
TROBICIN 050347 001 NDA SPECTINOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No Approved Prior to Jan 1, 1982 PFIZER DISCN 详细信息
TROBICIN 050347 002 NDA SPECTINOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 4GM BASE/VIAL No No Approved Prior to Jan 1, 1982 PFIZER DISCN 详细信息
TROPHAMINE 019018 001 NDA AMINO ACIDS INJECTABLE;INJECTION 6% (6GM/100ML) Yes Yes 1984/07/20 B BRAUN RX 详细信息
TROPHAMINE 10% 019018 003 NDA AMINO ACIDS INJECTABLE;INJECTION 10% (10GM/100ML) Yes Yes 1988/09/07 B BRAUN RX 详细信息
TROVAN PRESERVATIVE FREE 020760 001 NDA ALATROFLOXACIN MESYLATE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 1997/12/18 PFIZER DISCN 详细信息
TROVAN PRESERVATIVE FREE 020760 002 NDA ALATROFLOXACIN MESYLATE INJECTABLE;INJECTION EQ 300MG BASE/VIAL No No 1997/12/18 PFIZER DISCN 详细信息
TUBOCURARINE CHLORIDE 005657 001 NDA TUBOCURARINE CHLORIDE INJECTABLE;INJECTION 3MG/ML No No Approved Prior to Jan 1, 1982 BRISTOL MYERS SQUIBB DISCN 详细信息
TUBOCURARINE CHLORIDE 006095 001 NDA TUBOCURARINE CHLORIDE INJECTABLE;INJECTION 3MG/ML No No Approved Prior to Jan 1, 1982 HOSPIRA DISCN 详细信息
TUBOCURARINE CHLORIDE 006325 001 NDA TUBOCURARINE CHLORIDE INJECTABLE;INJECTION 3MG/ML No No Approved Prior to Jan 1, 1982 LILLY DISCN 详细信息
TYMTRAN 018296 001 NDA CERULETIDE DIETHYLAMINE INJECTABLE;INJECTION 0.02MG/ML No No Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN DISCN 详细信息
U-GENCIN 062248 001 ANDA GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 10MG BASE/ML No No Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN DISCN 详细信息
U-GENCIN 062248 002 ANDA GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 40MG BASE/ML No No Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN DISCN 详细信息
ULTACAN 201751 001 ANDA ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 4%;EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) No No 2017/07/11 HANSAMED INC DISCN 详细信息
ULTACAN FORTE 201750 001 ANDA ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) No No 2017/07/11 HANSAMED INC DISCN 详细信息
ULTIVA 020630 001 NDA REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/VIAL Yes No AP 1996/07/12 MYLAN INSTITUTIONAL RX 详细信息
ULTIVA 020630 002 NDA REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/VIAL Yes No AP 1996/07/12 MYLAN INSTITUTIONAL RX 详细信息
当前数据更新日期：2025年05月10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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