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
BUPIVACAINE HYDROCHLORIDE 216040 001 ANDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% No No AP 2023/12/27 MEITHEAL RX 详细信息
BUPIVACAINE HYDROCHLORIDE 216039 002 ANDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% No No AP 2023/06/23 MEITHEAL RX 详细信息
BUPIVACAINE HYDROCHLORIDE 216040 002 ANDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% No No AP 2023/12/27 MEITHEAL RX 详细信息
BUPIVACAINE HYDROCHLORIDE 216040 003 ANDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% No No AP 2023/12/27 MEITHEAL RX 详细信息
BUPIVACAINE HYDROCHLORIDE 217792 001 ANDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% No No AP 2023/11/20 SOMERSET RX 详细信息
BUPIVACAINE HYDROCHLORIDE 217792 002 ANDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% No No AP 2023/11/20 SOMERSET RX 详细信息
BUPIVACAINE HYDROCHLORIDE 091503 001 ANDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% No No AP 2011/10/18 STERISCIENCE SPECLTS RX 详细信息
BUPIVACAINE HYDROCHLORIDE 091503 002 ANDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.5% No No AP 2011/10/18 STERISCIENCE SPECLTS RX 详细信息
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 071165 001 ANDA BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE INJECTABLE;INJECTION 0.25%;0.005MG/ML No Yes 1988/06/16 HOSPIRA RX 详细信息
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 071166 001 ANDA BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE INJECTABLE;INJECTION 0.25%;0.005MG/ML No No 1988/06/16 HOSPIRA DISCN 详细信息
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 071167 001 ANDA BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE INJECTABLE;INJECTION 0.25%;0.005MG/ML No No 1988/06/16 HOSPIRA RX 详细信息
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 071168 001 ANDA BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE INJECTABLE;INJECTION 0.5%;0.005MG/ML No Yes AP 1988/06/16 HOSPIRA RX 详细信息
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 071169 001 ANDA BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE INJECTABLE;INJECTION 0.5%;0.005MG/ML No No 1988/06/16 HOSPIRA DISCN 详细信息
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 071170 001 ANDA BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE INJECTABLE;INJECTION 0.5%;0.005MG/ML No No AP 1988/06/16 HOSPIRA RX 详细信息
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 022046 001 NDA BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 0.5%;0.0091MG/ML Yes No 1983/07/13 HOSPIRA DISCN 详细信息
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 071171 001 ANDA BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE INJECTABLE;INJECTION 0.75%;0.005MG/ML No No 1988/06/16 HOSPIRA DISCN 详细信息
BUPIVACAINE HYDROCHLORIDE KIT 019978 001 NDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.075% No No 1992/09/03 HOSPIRA DISCN 详细信息
BUPIVACAINE HYDROCHLORIDE KIT 019978 002 NDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.114% No No 1992/09/03 HOSPIRA DISCN 详细信息
BUPIVACAINE HYDROCHLORIDE KIT 019978 003 NDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.23% No No 1992/09/03 HOSPIRA DISCN 详细信息
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 203895 001 ANDA BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.25% No No AP 2013/11/05 EUGIA PHARMA RX 详细信息
当前数据更新日期:2024年11月21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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