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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) 021300 | 001 | CLARINEX | DESLORATADINE | 地氯雷他定 | SOLUTION;ORAL | 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | MERCK SHARP DOHME | 2004-09-01 | Yes | No | DISCN | |
(ANDA) 202592 | 001 | DESLORATADINE | DESLORATADINE | 地氯雷他定 | SOLUTION;ORAL | 0.5MG/ML | TARO | 2015-06-30 | No | No | DISCN | |
(ANDA) 202936 | 001 | DESLORATADINE | DESLORATADINE | 地氯雷他定 | SOLUTION;ORAL | 0.5MG/ML | TARO | 2016-05-26 | No | No | DISCN | |
(NDA) 021605 | 001 | CLARINEX D 24 HOUR | DESLORATADINE; PSEUDOEPHEDRINE SULFATE | 地氯雷他定;硫酸伪麻黄碱 | TABLET, EXTENDED RELEASE;ORAL | 5MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ORGANON | 2005-03-03 | Yes | No | DISCN | |
(NDA) 021313 | 001 | CLARINEX-D 12 HOUR | DESLORATADINE; PSEUDOEPHEDRINE SULFATE | 地氯雷他定;硫酸伪麻黄碱 | TABLET, EXTENDED RELEASE;ORAL | 2.5MG;120MG | ORGANON LLC | 2006-02-01 | Yes | Yes | RX | |
(ANDA) 078366 | 001 | DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR | DESLORATADINE; PSEUDOEPHEDRINE SULFATE | 地氯雷他定;硫酸伪麻黄碱 | TABLET, EXTENDED RELEASE;ORAL | 5MG;240MG | DR REDDYS LABS LTD | 2011-04-26 | No | Yes | RX | |
(ANDA) 078367 | 002 | DESLORATADINE | DESLORATADINE | 地氯雷他定 | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | REDDYS | 2010-07-12 | No | Yes | RX | |
(ANDA) 078367 | 001 | DESLORATADINE | DESLORATADINE | 地氯雷他定 | TABLET, ORALLY DISINTEGRATING;ORAL | 2.5MG | REDDYS | 2010-07-12 | No | No | RX | |
(NDA) 021312 | 001 | CLARINEX | DESLORATADINE | 地氯雷他定 | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ORGANON | 2002-06-26 | Yes | No | DISCN | |
(NDA) 021312 | 002 | CLARINEX | DESLORATADINE | 地氯雷他定 | TABLET, ORALLY DISINTEGRATING;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ORGANON | 2005-07-14 | Yes | No | DISCN | |
(ANDA) 078361 | 001 | DESLORATADINE | DESLORATADINE | 地氯雷他定 | TABLET;ORAL | 5MG | PERRIGO | 2011-12-22 | No | No | DISCN | |
(ANDA) 078357 | 001 | DESLORATADINE | DESLORATADINE | 地氯雷他定 | TABLET;ORAL | 5MG | ORBION PHARMS | 2010-02-19 | No | No | RX | AB |
(ANDA) 078352 | 001 | DESLORATADINE | DESLORATADINE | 地氯雷他定 | TABLET;ORAL | 5MG | LUPIN PHARMS | 2010-10-25 | No | No | RX | AB |
(ANDA) 078365 | 001 | DESLORATADINE | DESLORATADINE | 地氯雷他定 | TABLET;ORAL | 5MG | DR REDDYS LABS LTD | 2011-03-08 | No | No | RX | AB |
(ANDA) 078351 | 001 | DESLORATADINE | DESLORATADINE | 地氯雷他定 | TABLET;ORAL | 5MG | DASH PHARMS | 2012-02-10 | No | No | DISCN | |
(ANDA) 078364 | 001 | DESLORATADINE | DESLORATADINE | 地氯雷他定 | TABLET;ORAL | 5MG | CHARTWELL RX | 2010-12-03 | No | No | DISCN | |
(ANDA) 078355 | 001 | DESLORATADINE | DESLORATADINE | 地氯雷他定 | TABLET;ORAL | 5MG | AJENAT PHARMS | 2012-04-19 | No | No | RX | AB |
(NDA) 021165 | 001 | CLARINEX | DESLORATADINE | 地氯雷他定 | TABLET;ORAL | 5MG | ORGANON | 2001-12-21 | Yes | Yes | RX | AB |
(ANDA) 078359 | 001 | DESLORATADINE | DESLORATADINE | 地氯雷他定 | TABLET;ORAL | 5MG | SUN PHARM INDS | 2010-11-16 | No | No | DISCN |