美国FDA药品橙皮书数据库
（U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations）
请输入需要查询的英文药品商品名，活性成分，申请号
*Search by Trade Name,Active Ingredient,Application Number.
高级搜索
数据记录共 48215 条，共 2411 页，当前第 99 页
可点击列名称排序
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
SANDOSTATIN 019667 004 NDA OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1991/06/12 NOVARTIS DISCN 详细信息
SANDOSTATIN 019667 003 NDA OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.5MG BASE/ML Yes Yes AP 1988/10/21 NOVARTIS RX 详细信息
SANDOSTATIN 019667 005 NDA OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1991/06/12 NOVARTIS DISCN 详细信息
SANDOSTATIN LAR 021008 001 NDA OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 10MG BASE/VIAL Yes No AB 1998/11/25 NOVARTIS RX 详细信息
SANDOSTATIN LAR 021008 002 NDA OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 20MG BASE/VIAL Yes No AB 1998/11/25 NOVARTIS RX 详细信息
SANDOSTATIN LAR 021008 003 NDA OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 30MG BASE/VIAL Yes Yes AB 1998/11/25 NOVARTIS RX 详细信息
SANDRIL 010012 001 NDA RESERPINE INJECTABLE;INJECTION 2.5MG/ML No No Approved Prior to Jan 1, 1982 LILLY DISCN 详细信息
SARENIN 018009 001 NDA SARALASIN ACETATE INJECTABLE;INJECTION EQ 0.6MG BASE/ML No No Approved Prior to Jan 1, 1982 PROCTER AND GAMBLE DISCN 详细信息
SCANDONEST L 088388 001 ANDA LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.05MG/ML;2% No No 1984/10/10 DEPROCO DISCN 详细信息
SCANDONEST PLAIN 088387 001 ANDA MEPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 3% No Yes 1984/10/10 DEPROCO RX 详细信息
SCANLUX-300 090394 001 ANDA IOPAMIDOL INJECTABLE;INJECTION 61% No No 2010/06/18 SANOCHEMIA CORP USA DISCN 详细信息
SCANLUX-370 090394 002 ANDA IOPAMIDOL INJECTABLE;INJECTION 76% No No 2010/06/18 SANOCHEMIA CORP USA DISCN 详细信息
SECOBARBITAL SODIUM 083281 001 ANDA SECOBARBITAL SODIUM INJECTABLE;INJECTION 100MG/VIAL No No Approved Prior to Jan 1, 1982 ELKINS SINN DISCN 详细信息
SECOBARBITAL SODIUM 083262 001 ANDA SECOBARBITAL SODIUM INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 WYETH AYERST DISCN 详细信息
SECONAL SODIUM 007392 002 NDA SECOBARBITAL SODIUM INJECTABLE;INJECTION 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No Approved Prior to Jan 1, 1982 LILLY DISCN 详细信息
SECRETIN-FERRING 018290 001 NDA SECRETIN INJECTABLE;INJECTION 75CU/VIAL No No Approved Prior to Jan 1, 1982 FERRING DISCN 详细信息
SEFFIN 062435 001 ANDA CEPHALOTHIN SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 1983/11/15 GLAXOSMITHKLINE DISCN 详细信息
SEFFIN 062435 002 ANDA CEPHALOTHIN SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No 1983/11/15 GLAXOSMITHKLINE DISCN 详细信息
SEFFIN 062435 003 ANDA CEPHALOTHIN SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL No No 1983/11/15 GLAXOSMITHKLINE DISCN 详细信息
SELENOMETHIONINE SE 75 017257 001 NDA SELENOMETHIONINE SE-75 INJECTABLE;INJECTION 250uCi/ML No No Approved Prior to Jan 1, 1982 GE HEALTHCARE 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。
©2006-2026 DrugFuture->U.S. FDA Orange Book