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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) 021165 | 001 | CLARINEX | DESLORATADINE | 地氯雷他定 | TABLET;ORAL | 5MG | ORGANON | 2001-12-21 | Yes | Yes | RX | AB |
(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地氯雷他定 | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ORGANON | 2002-06-26 | Yes | No | DISCN | |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) 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) 020704 | 002 | CLARITIN REDITABS | LORATADINE | 氯雷他定 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | BAYER HEALTHCARE LLC | 2002-11-27 | 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) 020641 | 002 | CLARITIN | LORATADINE | 氯雷他定 | SYRUP;ORAL | 1MG/ML | BAYER HEALTHCARE LLC | 2002-11-27 | 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) 021375 | 001 | ALAVERT | LORATADINE | 氯雷他定 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | FDN CONSUMER | 2002-12-19 | No | No | OTC | |
(ANDA) 075209 | 001 | LORATADINE | LORATADINE | 氯雷他定 | TABLET;ORAL | 10MG | PLD ACQUISITIONS LLC | 2003-01-21 | No | No | OTC | |
(ANDA) 076050 | 001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 氯雷他定;硫酸伪麻黄碱 | TABLET, EXTENDED RELEASE;ORAL | 5MG;120MG | PERRIGO PHARMA INTL | 2003-01-30 | No | No | OTC | |
(ANDA) 075822 | 001 | LORATADINE | LORATADINE | 氯雷他定 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | GLAXOSMITHKLINE | 2003-02-10 | No | No | DISCN | |
(ANDA) 075706 | 001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 氯雷他定;硫酸伪麻黄碱 | TABLET, EXTENDED RELEASE;ORAL | 10MG;240MG | P AND L | 2003-02-21 | No | No | OTC | |
(ANDA) 076134 | 001 | LORATADINE | LORATADINE | 氯雷他定 | TABLET;ORAL | 10MG | SUN PHARM INDS LTD | 2003-08-18 | No | No | OTC | |
(ANDA) 076154 | 001 | LORATADINE | LORATADINE | 氯雷他定 | TABLET;ORAL | 10MG | MYLAN | 2003-08-20 | No | No | OTC | |
(ANDA) 076011 | 001 | LORATADINE | LORATADINE | 氯雷他定 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | PERRIGO PHARMA INTL | 2003-09-29 | No | No | OTC | |
(ANDA) 075990 | 001 | LORATADINE | LORATADINE | 氯雷他定 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | ACTAVIS LABS FL INC | 2003-11-03 | No | No | DISCN | |
(ANDA) 075505 | 001 | LORATADINE | LORATADINE | 氯雷他定 | SYRUP;ORAL | 1MG/ML | TEVA | 2003-11-07 | No | No | DISCN | |
(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) 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 | 003 | CLARITIN HIVES RELIEF | LORATADINE | 氯雷他定 | TABLET;ORAL | 10MG | BAYER HEALTHCARE LLC | 2003-11-19 | Yes | Yes | OTC |