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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) 021952 | 001 | CLARITIN | LORATADINE | 氯雷他定 | CAPSULE;ORAL | 10MG | BAYER HEALTHCARE LLC | 2008-06-16 | Yes | Yes | OTC | |
(NDA) 021993 | 001 | CLARITIN REDITABS | LORATADINE | 氯雷他定 | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | BAYER HEALTHCARE LLC | 2006-12-12 | Yes | Yes | OTC | |
(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地氯雷他定 | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ORGANON | 2002-06-26 | Yes | No | DISCN | |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| TABLET, ORALLY DISINTEGRATING;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ORGANON | 2005-07-14 | Yes | No | DISCN | |
(NDA) 019670 | 002 | CLARITIN-D | LORATADINE; PSEUDOEPHEDRINE SULFATE | 氯雷他定;硫酸伪麻黄碱 | TABLET, EXTENDED RELEASE;ORAL | 5MG;120MG | BAYER HEALTHCARE LLC | 2002-11-27 | Yes | Yes | OTC | |
(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 | |
(NDA) 019658 | 003 | CLARITIN HIVES RELIEF | LORATADINE | 氯雷他定 | TABLET;ORAL | 10MG | BAYER HEALTHCARE LLC | 2003-11-19 | Yes | Yes | OTC | |
(NDA) 020641 | 003 | CLARITIN HIVES RELIEF | LORATADINE | 氯雷他定 | SYRUP;ORAL | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BAYER HEALTHCARE LLC | 2003-11-19 | Yes | No | DISCN | |
(NDA) 020641 | 002 | CLARITIN | LORATADINE | 氯雷他定 | SYRUP;ORAL | 1MG/ML | BAYER HEALTHCARE LLC | 2002-11-27 | Yes | Yes | OTC | |
(NDA) 021734 | 001 | LORATADINE | LORATADINE | 氯雷他定 | SUSPENSION;ORAL | 1MG/ML | TARO | 2005-10-04 | Yes | Yes | OTC | |
(NDA) 020470 | 002 | CLARITIN-D 24 HOUR | LORATADINE; PSEUDOEPHEDRINE SULFATE | 氯雷他定;硫酸伪麻黄碱 | TABLET, EXTENDED RELEASE;ORAL | 10MG;240MG | BAYER HEALTHCARE LLC | 2002-11-27 | Yes | Yes | OTC | |
(NDA) 021891 | 001 | CHILDREN'S CLARITIN | LORATADINE | 氯雷他定 | TABLET, CHEWABLE;ORAL | 5MG | BAYER HEALTHCARE LLC | 2006-08-23 | Yes | No | OTC | |
(NDA) 021165 | 001 | CLARINEX | DESLORATADINE | 地氯雷他定 | TABLET;ORAL | 5MG | ORGANON | 2001-12-21 | Yes | Yes | RX | AB |
(NDA) 021891 | 002 | CLARITIN | LORATADINE | 氯雷他定 | TABLET, CHEWABLE;ORAL | 10MG | BAYER HEALTHCARE LLC | 2018-11-21 | Yes | Yes | OTC | |
(NDA) 020704 | 003 | CLARITIN HIVES RELIEF REDITAB | LORATADINE | 氯雷他定 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | BAYER HEALTHCARE LLC | 2003-11-19 | Yes | Yes | OTC | |
(NDA) 019658 | 002 | CLARITIN | LORATADINE | 氯雷他定 | TABLET;ORAL | 10MG | BAYER HEALTHCARE LLC | 2002-11-27 | Yes | Yes | OTC | |
(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 | |
(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) 020704 | 002 | CLARITIN REDITABS | LORATADINE | 氯雷他定 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | BAYER HEALTHCARE LLC | 2002-11-27 | Yes | Yes | OTC | |
(ANDA) 077421 | 001 | LORATADINE | LORATADINE | 氯雷他定 | SYRUP;ORAL | 1MG/ML | LANNETT CO INC | 2006-06-29 | No | No | OTC |