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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) 021374 | 001 | ADVIL COLD AND SINUS | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 布洛芬;盐酸伪麻黄碱 | CAPSULE;ORAL | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | HALEON US HOLDINGS | 2002-05-30 | Yes | Yes | OTC | |
(ANDA) 209235 | 001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 布洛芬;盐酸伪麻黄碱 | CAPSULE;ORAL | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | AUROBINDO PHARMA | 2017-12-01 | No | No | OTC | |
(NDA) 021373 | 001 | CHILDREN'S ADVIL COLD | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 布洛芬;盐酸伪麻黄碱 | SUSPENSION;ORAL | 100MG/5ML;15MG/5ML | HALEON US HOLDINGS | 2002-04-18 | No | No | OTC | |
(ANDA) 076478 | 001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 布洛芬;盐酸伪麻黄碱 | SUSPENSION;ORAL | 100MG/5ML;15MG/5ML | PERRIGO | 2003-11-05 | No | No | DISCN | |
(NDA) 019899 | 001 | SINE-AID IB | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 布洛芬;盐酸伪麻黄碱 | TABLET;ORAL | 200MG;30MG | KENVUE BRANDS | 1992-12-31 | No | No | OTC | |
(ANDA) 074567 | 001 | IBUPROHM COLD AND SINUS | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 布洛芬;盐酸伪麻黄碱 | TABLET;ORAL | 200MG;30MG | OHM LABS | 2001-04-17 | No | No | OTC | |
(ANDA) 075588 | 001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 布洛芬;盐酸伪麻黄碱 | TABLET;ORAL | 200MG;30MG | CONTRACT PHARMACAL | 2002-04-08 | No | No | DISCN | |
(NDA) 019771 | 001 | ADVIL COLD AND SINUS | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 布洛芬;盐酸伪麻黄碱 | TABLET;ORAL | 200MG;30MG | HALEON US HOLDINGS | 1989-09-19 | Yes | Yes | OTC | |
(NDA) 021128 | 001 | CHILDREN'S MOTRIN COLD | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 布洛芬;盐酸伪麻黄碱 | SUSPENSION;ORAL | 100MG/5ML;15MG/5ML | KENVUE BRANDS | 2000-08-01 | Yes | Yes | OTC | |
(ANDA) 077628 | 001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 布洛芬;盐酸伪麻黄碱 | TABLET;ORAL | 200MG;30MG | DR REDDYS LABS LTD | 2006-08-14 | No | No | OTC | |
(ANDA) 213565 | 001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 布洛芬;盐酸伪麻黄碱 | TABLET;ORAL | 200MG;30MG | AUROBINDO PHARMA LTD | 2023-03-10 | No | No | DISCN | |
(ANDA) 203200 | 001 | IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE | IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 布洛芬;盐酸去氧肾上腺素 | TABLET;ORAL | 200MG;10MG | PERRIGO R AND D | 2014-07-03 | No | No | OTC | |
(NDA) 022565 | 001 | ADVIL CONGESTION RELIEF | IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 布洛芬;盐酸去氧肾上腺素 | TABLET;ORAL | 200MG;10MG | HALEON US HOLDINGS | 2010-05-27 | Yes | Yes | OTC | |
(NDA) 021378 | 001 | COMBUNOX | IBUPROFEN; OXYCODONE HYDROCHLORIDE | 布洛芬;盐酸羟考酮 | TABLET;ORAL | 400MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOREST LABS | 2004-11-26 | Yes | No | DISCN | |
(ANDA) 078316 | 001 | OXYCODONE HYDROCHLORIDE AND IBUPROFEN | IBUPROFEN; OXYCODONE HYDROCHLORIDE | 布洛芬;盐酸羟考酮 | TABLET;ORAL | 400MG;5MG | BARR LABS INC | 2007-11-29 | No | No | DISCN | |
(ANDA) 078394 | 001 | OXYCODONE HYDROCHLORIDE AND IBUPROFEN | IBUPROFEN; OXYCODONE HYDROCHLORIDE | 布洛芬;盐酸羟考酮 | TABLET;ORAL | 400MG;5MG | WATSON LABS | 2007-11-26 | No | No | DISCN | |
(ANDA) 078769 | 001 | OXYCODONE HYDROCHLORIDE AND IBUPROFEN | IBUPROFEN; OXYCODONE HYDROCHLORIDE | 布洛芬;盐酸羟考酮 | TABLET;ORAL | 400MG;5MG | ACTAVIS ELIZABETH | 2008-01-04 | No | No | DISCN | |
(NDA) 201803 | 001 | ADVIL | IBUPROFEN SODIUM | 布洛芬钠 | TABLET;ORAL | EQ 200MG BASE | HALEON US HOLDINGS | 2012-06-12 | Yes | Yes | OTC | |
(ANDA) 206581 | 001 | IBUPROFEN SODIUM | IBUPROFEN SODIUM | 布洛芬钠 | TABLET;ORAL | EQ 200MG BASE | PERRIGO R AND D | 2015-08-03 | No | No | DISCN | |
(ANDA) 202402 | 001 | IBUPROFEN LYSINE | IBUPROFEN LYSINE | INJECTABLE;INTRAVENOUS | EQ 20MG BASE/2ML (EQ 10MG BASE/ML) | XGEN PHARMS | 2016-03-30 | No | No | RX | AP |