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
SUMYCIN 060400 001 ANDA TETRACYCLINE HYDROCHLORIDE SUSPENSION;ORAL 125MG/5ML No No Approved Prior to Jan 1, 1982 PAR PHARM DISCN 详细信息
TAGAMET HB 200 020951 001 NDA CIMETIDINE SUSPENSION;ORAL 200MG/20ML No No 1999/07/09 GLAXOSMITHKLINE DISCN 详细信息
TAGITOL V 208143 005 NDA BARIUM SULFATE SUSPENSION;ORAL 40% (8GM/BOT) Yes Yes 2017/08/04 BRACCO RX 详细信息
TAO 050332 001 NDA TROLEANDOMYCIN SUSPENSION;ORAL EQ 125MG BASE/5ML No No Approved Prior to Jan 1, 1982 PFIZER DISCN 详细信息
TEGRETOL 018927 001 NDA CARBAMAZEPINE SUSPENSION;ORAL 100MG/5ML Yes Yes AB 1987/12/18 NOVARTIS RX 详细信息
TERFONYL 006904 002 NDA TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE) SUSPENSION;ORAL 167MG/5ML;167MG/5ML;167MG/5ML No No Approved Prior to Jan 1, 1982 BRISTOL MYERS SQUIBB DISCN 详细信息
TERIL 076729 001 ANDA CARBAMAZEPINE SUSPENSION;ORAL 100MG/5ML No No AB 2004/09/20 TARO PHARM RX 详细信息
TETRACYCLINE HYDROCHLORIDE 060633 001 ANDA TETRACYCLINE HYDROCHLORIDE SUSPENSION;ORAL 125MG/5ML No No Approved Prior to Jan 1, 1982 ALPHARMA US PHARMS DISCN 详细信息
TETRACYCLINE HYDROCHLORIDE 060174 001 ANDA TETRACYCLINE HYDROCHLORIDE SUSPENSION;ORAL 125MG/5ML No No Approved Prior to Jan 1, 1982 FERRANTE DISCN 详细信息
TETRACYCLINE HYDROCHLORIDE 060446 001 ANDA TETRACYCLINE HYDROCHLORIDE SUSPENSION;ORAL 125MG/5ML No No Approved Prior to Jan 1, 1982 PROTER DISCN 详细信息
TETRACYCLINE HYDROCHLORIDE 060291 001 ANDA TETRACYCLINE HYDROCHLORIDE SUSPENSION;ORAL 125MG/5ML No No Approved Prior to Jan 1, 1982 PUREPAC PHARM DISCN 详细信息
TETRACYN 060095 001 ANDA TETRACYCLINE HYDROCHLORIDE SUSPENSION;ORAL 125MG/5ML No No Approved Prior to Jan 1, 1982 PFIPHARMECS DISCN 详细信息
TETRAMED 061468 001 ANDA TETRACYCLINE HYDROCHLORIDE SUSPENSION;ORAL 125MG/5ML No No Approved Prior to Jan 1, 1982 IVAX SUB TEVA PHARMS DISCN 详细信息
TIGLUTIK KIT 209080 001 NDA RILUZOLE SUSPENSION;ORAL 50MG/10ML Yes Yes 2018/09/05 ITALFARMACO SPA RX 详细信息
TPN 008378 003 NDA NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; TYROSINE SUSPENSION;ORAL 15MG/5ML;3.75MG/5ML;600MG/5ML No No Approved Prior to Jan 1, 1982 INTL MINERALS DISCN 详细信息
TRILEPTAL 021285 001 NDA OXCARBAZEPINE SUSPENSION;ORAL 300MG/5ML Yes Yes AB 2001/05/25 NOVARTIS RX 详细信息
TRIMETH/SULFA 072289 001 ANDA SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION;ORAL 200MG/5ML;40MG/5ML No No 1988/05/23 ALPHARMA US PHARMS DISCN 详细信息
TRIMETH/SULFA 072398 001 ANDA SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION;ORAL 200MG/5ML;40MG/5ML No No 1988/05/23 ALPHARMA US PHARMS DISCN 详细信息
TRIMETH/SULFA 072399 001 ANDA SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION;ORAL 200MG/5ML;40MG/5ML No No 1988/05/23 NASKA DISCN 详细信息
TRIPLE SULFA 080280 001 ANDA TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE) SUSPENSION;ORAL 167MG/5ML;167MG/5ML;167MG/5ML No No Approved Prior to Jan 1, 1982 ALPHARMA US PHARMS DISCN 详细信息
当前数据更新日期:2019年05月12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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