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申请号 | 产品号 | 商品名 | 活性成分 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 申请机构 | 批准时间 | 参比制剂 | 标准制剂 | 市场状态 | TE |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(NDA) 017463 | 002 | MOTRIN | IBUPROFEN | 布洛芬 | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | MCNEIL CONSUMER | 1982-01-01 | Yes | No | DISCN | |
(NDA) 017463 | 003 | MOTRIN | IBUPROFEN | 布洛芬 | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | MCNEIL CONSUMER | 1982-01-01 | Yes | No | DISCN | |
(NDA) 017463 | 004 | MOTRIN | IBUPROFEN | 布洛芬 | TABLET;ORAL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | MCNEIL CONSUMER | 1982-01-01 | Yes | No | DISCN | |
(NDA) 018197 | 001 | IBU | IBUPROFEN | 布洛芬 | TABLET;ORAL | 400MG | BASF | 1982-01-01 | No | No | DISCN | |
(NDA) 018197 | 002 | RUFEN | IBUPROFEN | 布洛芬 | TABLET;ORAL | 600MG | BASF | 1984-03-05 | No | No | DISCN | |
(NDA) 019012 | 001 | NUPRIN | IBUPROFEN | 布洛芬 | TABLET;ORAL | 200MG | KENVUE BRANDS | 1984-05-18 | No | No | DISCN | |
(NDA) 018989 | 001 | ADVIL | IBUPROFEN | 布洛芬 | TABLET;ORAL | 200MG | HALEON US HOLDINGS | 1984-05-18 | Yes | Yes | OTC | |
(ANDA) 070088 | 001 | IBU | IBUPROFEN | 布洛芬 | TABLET;ORAL | 600MG | BASF | 1985-02-08 | No | No | DISCN | |
(ANDA) 070083 | 001 | IBU | IBUPROFEN | 布洛芬 | TABLET;ORAL | 400MG | BASF | 1985-02-22 | No | No | DISCN | |
(ANDA) 070099 | 001 | IBU | IBUPROFEN | 布洛芬 | TABLET;ORAL | 600MG | BASF | 1985-03-29 | No | No | DISCN | |
(NDA) 017463 | 005 | MOTRIN | IBUPROFEN | 布洛芬 | TABLET;ORAL | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | MCNEIL CONSUMER | 1985-05-22 | Yes | No | DISCN | |
(ANDA) 070556 | 001 | IBUPROFEN | IBUPROFEN | 布洛芬 | TABLET;ORAL | 600MG | ABBOTT | 1985-06-14 | No | No | DISCN | |
(ANDA) 070079 | 001 | IBUPROFEN | IBUPROFEN | 布洛芬 | TABLET;ORAL | 400MG | SUN PHARM INDUSTRIES | 1985-07-24 | No | No | DISCN | |
(ANDA) 070080 | 001 | IBUPROFEN | IBUPROFEN | 布洛芬 | TABLET;ORAL | 600MG | SUN PHARM INDUSTRIES | 1985-07-24 | No | No | DISCN | |
(ANDA) 070330 | 001 | IBUPROFEN | IBUPROFEN | 布洛芬 | TABLET;ORAL | 600MG | STRIDES PHARMA | 1985-08-06 | No | No | DISCN | |
(ANDA) 070328 | 001 | IBUPROFEN | IBUPROFEN | 布洛芬 | TABLET;ORAL | 300MG | PAR PHARM | 1985-08-06 | No | No | DISCN | |
(ANDA) 070329 | 001 | IBUPROFEN | IBUPROFEN | 布洛芬 | TABLET;ORAL | 400MG | STRIDES PHARMA | 1985-08-06 | No | No | DISCN | |
(ANDA) 070437 | 001 | IBUPROFEN | IBUPROFEN | 布洛芬 | TABLET;ORAL | 600MG | WATSON LABS | 1985-08-21 | No | No | DISCN | |
(ANDA) 070436 | 001 | IBUPROFEN | IBUPROFEN | 布洛芬 | TABLET;ORAL | 400MG | WATSON LABS | 1985-08-21 | No | No | DISCN | |
(ANDA) 070469 | 001 | IBUPROHM | IBUPROFEN | 布洛芬 | TABLET;ORAL | 400MG | OHM LABS | 1985-08-29 | No | No | DISCN |