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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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(ANDA) 218017 | 001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 氯雷他定;硫酸伪麻黄碱 | TABLET, EXTENDED RELEASE;ORAL | 10MG;240MG | BIONPHARMA | 2024-05-14 | No | No | OTC | |
(ANDA) 075989 | 001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 氯雷他定;硫酸伪麻黄碱 | TABLET, EXTENDED RELEASE;ORAL | 10MG;240MG | PERRIGO PHARMA INTL | 2004-03-04 | No | No | OTC | |
(ANDA) 076208 | 001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 氯雷他定;硫酸伪麻黄碱 | TABLET, EXTENDED RELEASE;ORAL | 5MG;120MG | HERITAGE PHARMA | 2004-01-28 | 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) 076557 | 001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 氯雷他定;硫酸伪麻黄碱 | TABLET, EXTENDED RELEASE;ORAL | 10MG;240MG | SUN PHARM INDS LTD | 2004-09-22 | 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 | |
(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) 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 | |
(ANDA) 077421 | 001 | LORATADINE | LORATADINE | 氯雷他定 | SYRUP;ORAL | 1MG/ML | LANNETT CO INC | 2006-06-29 | No | No | OTC | |
(NDA) 021952 | 001 | CLARITIN | LORATADINE | 氯雷他定 | CAPSULE;ORAL | 10MG | BAYER HEALTHCARE LLC | 2008-06-16 | Yes | Yes | OTC | |
(ANDA) 214684 | 001 | LORATADINE | LORATADINE | 氯雷他定 | TABLET;ORAL | 10MG | UNIQUE PHARM | 2021-01-07 | No | No | OTC | |
(ANDA) 201865 | 001 | LORATADINE | LORATADINE | 氯雷他定 | SYRUP;ORAL | 1MG/ML | TARO | 2015-07-31 | No | No | OTC | |
(ANDA) 210409 | 001 | LORATADINE | LORATADINE | 氯雷他定 | SYRUP;ORAL | 1MG/ML | HETERO LABS LTD III | 2021-05-07 | No | No | OTC | |
(ANDA) 208931 | 001 | LORATADINE | LORATADINE | 氯雷他定 | SYRUP;ORAL | 1MG/ML | AUROBINDO PHARMA LTD | 2018-06-29 | No | No | 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 | |
(ANDA) 211926 | 001 | LORATADINE | LORATADINE | 氯雷他定 | CAPSULE;ORAL | 10MG | STRIDES SOFTGELS | 2020-01-15 | No | No | DISCN | |
(ANDA) 206214 | 001 | LORATADINE | LORATADINE | 氯雷他定 | CAPSULE;ORAL | 10MG | MARKSANS PHARMA | 2016-09-23 | No | No | OTC | |
(ANDA) 202538 | 001 | LORATADINE | LORATADINE | 氯雷他定 | CAPSULE;ORAL | 10MG | BIONPHARMA | 2018-12-21 | No | No | OTC |