美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ARGATROBAN"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
ARGATROBAN 020883 001 NDA ARGATROBAN INJECTABLE;INJECTION 250MG/2.5ML (100MG/ML) Yes Yes 2000/06/30 2000/06/30 NOVARTIS Prescription
ARGATROBAN 022359 001 NDA ARGATROBAN INJECTABLE; INJECTION 250MG/250ML No 2010/07/28 (TA) BAXTER HLTHCARE CORP None (Tentative Approval)
ARGATROBAN 079238 001 ANDA ARGATROBAN INJECTABLE; INJECTION 100MG No 2010/12/29 (TA) PLIVA HRVATSKA DOO None (Tentative Approval)
ARGATROBAN IN SODIUM CHLORIDE 022485 001 NDA ARGATROBAN INJECTABLE;INTRAVENOUS 125MG/125ML (1MG/ML) Yes Yes 2011/05/09 2011/05/09 SANDOZ Prescription
ARGATROBAN IN DEXTROSE 201743 001 NDA ARGATROBAN SOLUTION;INTRAVENOUS 125MG/125ML (1MG/ML) No No 2011/05/09 2011/05/09 SANDOZ Discontinued
ARGATROBAN IN SODIUM CHLORIDE 022434 001 NDA ARGATROBAN INJECTABLE;INTRAVENOUS 50MG/50ML (1MG/ML) Yes Yes 2011/06/29 2011/06/29 EAGLE PHARMS Prescription
ARGATROBAN 203049 001 NDA ARGATROBAN INJECTABLE;INJECTION 250MG/2.5ML (100MG/ML) No No 2012/01/05 2012/01/05 HIKMA PHARM CO LTD Prescription
ARGATROBAN 203049 002 NDA ARGATROBAN INJECTABLE;INJECTION 50MG/50ML (1MG/ML) Yes Yes 2012/01/05 2016/09/30 HIKMA PHARM CO LTD Prescription
ARGATROBAN 091665 001 ANDA ARGATROBAN INJECTABLE;INJECTION 250MG/2.5ML (100MG/ML) No No 2014/06/30 2014/06/30 PAR STERILE PRODUCTS Prescription
ARGATROBAN 202626 001 ANDA ARGATROBAN INJECTABLE;INJECTION 250MG/2.5ML (100MG/ML) No No 2014/06/30 2014/06/30 MYLAN INSTITUTIONAL Prescription
ARGATROBAN IN 0.9% SODIUM CHLORIDE 206769 001 NDA ARGATROBAN INJECTABLE;INTRAVENOUS 250MG/250ML (1MG/ML) No No 2014/12/15 2014/12/15 TEVA PHARMS USA Prescription
ARGATROBAN 201811 001 NDA ARGATROBAN INJECTABLE;INJECTION 250MG/2.5ML (100MG/ML) No No 2015/03/23 2015/03/23 FRESENIUS KABI USA Prescription
ARGATROBAN 204120 001 ANDA ARGATROBAN INJECTABLE;INJECTION 250MG/2.5ML (100MG/ML) No No 2016/09/21 2016/09/21 HOSPIRA INC Prescription
ARGATROBAN IN SODIUM CHLORIDE 205570 001 ANDA ARGATROBAN INJECTABLE;INTRAVENOUS 125MG/125ML (1MG/ML) No No 2017/05/22 2017/05/22 GLAND PHARMA LTD Prescription
ARGATROBAN 206698 001 ANDA ARGATROBAN INJECTABLE;INJECTION 250MG/2.5ML (100MG/ML) No No 2018/01/26 2018/01/26 AMNEAL PHARMS CO Prescription
ARGATROBAN IN SODIUM CHLORIDE 209552 001 NDA ARGATROBAN SOLUTION;INTRAVENOUS 50MG/50ML (1MG/ML) No No 2018/11/27 2018/11/27 AUROBINDO PHARMA LTD Prescription
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