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 100 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
SELENOMETHIONINE SE 75 017098 001 NDA SELENOMETHIONINE SE-75 INJECTABLE;INJECTION 100uCi/ML No No Approved Prior to Jan 1, 1982 MALLINCKRODT DISCN 详细信息
SELENOMETHIONINE SE 75 017322 001 NDA SELENOMETHIONINE SE-75 INJECTABLE;INJECTION 500uCi/ML No No Approved Prior to Jan 1, 1982 PHARMALUCENCE DISCN 详细信息
SENSORCAINE 070966 001 ANDA BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.25%;0.0091MG/ML No No AP 1987/10/13 FRESENIUS KABI USA RX 详细信息
SENSORCAINE 070967 001 ANDA BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.25%;0.0091MG/ML No No AP 1987/10/13 FRESENIUS KABI USA RX 详细信息
SENSORCAINE 070552 001 ANDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% No No AP 1986/05/21 FRESENIUS KABI USA RX 详细信息
SENSORCAINE 018304 001 NDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% Yes No AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA RX 详细信息
SENSORCAINE 070968 001 ANDA BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.5%;0.0091MG/ML No No AP 1987/10/13 FRESENIUS KABI USA RX 详细信息
SENSORCAINE 018304 004 NDA BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.5%;0.0091MG/ML Yes No AP 1983/09/02 FRESENIUS KABI USA RX 详细信息
SENSORCAINE 070553 001 ANDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% No No AP 1986/05/21 FRESENIUS KABI USA RX 详细信息
SENSORCAINE 018304 002 NDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% Yes No AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA RX 详细信息
SENSORCAINE 018304 005 NDA BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.75%;0.0091MG/ML Yes No AP 1983/09/02 FRESENIUS KABI USA RX 详细信息
SENSORCAINE 070554 001 ANDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% No No AP 1986/05/21 FRESENIUS KABI USA RX 详细信息
SENSORCAINE 018304 003 NDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% Yes No AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA RX 详细信息
SEPTOCAINE 020971 002 NDA ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) Yes Yes 2006/03/30 DEPROCO RX 详细信息
SEPTOCAINE 020971 001 NDA ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) Yes Yes 2000/04/03 DEPROCO RX 详细信息
SEPTRA 018452 001 NDA SULFAMETHOXAZOLE; TRIMETHOPRIM INJECTABLE;INJECTION 80MG/ML;16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No Approved Prior to Jan 1, 1982 MONARCH PHARMS DISCN 详细信息
SERENTIL 016775 001 NDA MESORIDAZINE BESYLATE INJECTABLE;INJECTION EQ 25MG BASE/ML No No Approved Prior to Jan 1, 1982 NOVARTIS DISCN 详细信息
SERPASIL 009434 002 NDA RESERPINE INJECTABLE;INJECTION 2.5MG/ML No No Approved Prior to Jan 1, 1982 NOVARTIS DISCN 详细信息
SETHOTOPE 017047 001 NDA SELENOMETHIONINE SE-75 INJECTABLE;INJECTION 85-550uCi/ML No No Approved Prior to Jan 1, 1982 BRACCO DISCN 详细信息
SODIUM CHLORIDE 017013 001 NDA SODIUM CHLORIDE INJECTABLE;INJECTION 20GM/100ML No No Approved Prior to Jan 1, 1982 ABBOTT 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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