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
ACETAZOLAMIDE 210423 001 ANDA ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE;ORAL 500MG No No AB 2019/02/19 ALEMBIC PHARMS LTD RX 详细信息
ACETAZOLAMIDE 205301 001 ANDA ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE;ORAL 500MG No No AB 2019/01/16 CADILA RX 详细信息
ACETAZOLAMIDE 040904 001 ANDA ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE;ORAL 500MG No No AB 2008/12/10 HERITAGE PHARMA RX 详细信息
ACETAZOLAMIDE 090779 001 ANDA ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE;ORAL 500MG No Yes AB 2011/07/14 INDICUS PHARMA RX 详细信息
ACETAZOLAMIDE 207401 001 ANDA ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE;ORAL 500MG No No AB 2020/10/01 MICRO LABS LTD INDIA RX 详细信息
ACETAZOLAMIDE 204691 001 ANDA ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE;ORAL 500MG No No AB 2016/03/29 NOSTRUM LABS INC RX 详细信息
ACETAZOLAMIDE 203434 001 ANDA ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE;ORAL 500MG No No AB 2016/09/30 NOVAST LABS RX 详细信息
ACETAZOLAMIDE 203917 001 ANDA ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE;ORAL 500MG No No 2019/06/18 RISING DISCN 详细信息
ACTIFED 018996 001 NDA PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG;5MG No No 1985/06/17 GLAXOSMITHKLINE DISCN 详细信息
ADDERALL XR 10 021303 001 NDA AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Yes No AB 2001/10/11 TAKEDA PHARMS USA RX 详细信息
ADDERALL XR 15 021303 006 NDA AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.75MG;3.75MG;3.75MG;3.75MG Yes No AB 2002/05/22 TAKEDA PHARMS USA RX 详细信息
ADDERALL XR 20 021303 002 NDA AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG;5MG;5MG;5MG Yes No AB 2001/10/11 TAKEDA PHARMS USA RX 详细信息
ADDERALL XR 25 021303 004 NDA AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Yes No AB 2002/05/22 TAKEDA PHARMS USA RX 详细信息
ADDERALL XR 30 021303 003 NDA AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Yes Yes AB 2001/10/11 TAKEDA PHARMS USA RX 详细信息
ADDERALL XR 5 021303 005 NDA AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Yes No AB 2002/05/22 TAKEDA PHARMS USA RX 详细信息
ADHANSIA XR 212038 001 NDA METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 25MG Yes No 2019/02/27 PURDUE PHARMA LP RX 详细信息
MELLARIL 011808 003 NDA THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 NOVARTIS DISCN 详细信息
MELLARIL 011808 016 NDA THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 NOVARTIS DISCN 详细信息
MELLARIL 011808 006 NDA THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 NOVARTIS DISCN 详细信息
MELLARIL 011808 011 NDA THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 NOVARTIS DISCN 详细信息
当前数据更新日期:2022年01月20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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