药品注册申请号：017037
申请类型：NDA (新药申请)
申请人：HIKMA
申请人全名：HIKMA PHARMACEUTICALS USA INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Yes Yes AP 1972/03/22 Approved Prior to Jan 1, 1982 Prescription
002 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
003 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
013 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/0.5ML No No AP 1986/04/07 Prescription
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1972/03/22 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2024/10/24 SUPPL-201（补充） Approval Labeling-Package Insert STANDARD
2020/01/14 SUPPL-187（补充） Approval Manufacturing (CMC)-Formulation STANDARD
2019/05/18 SUPPL-183（补充） Approval Manufacturing (CMC)-Formulation N/A
2017/05/09 SUPPL-178（补充） Approval Labeling-Package Insert STANDARD
2015/12/23 SUPPL-175（补充） Approval Manufacturing (CMC) STANDARD
2015/12/02 SUPPL-174（补充） Approval Manufacturing (CMC) STANDARD
2015/10/30 SUPPL-176（补充） Approval Manufacturing (CMC) STANDARD
2015/01/05 SUPPL-173（补充） Approval Manufacturing (CMC) STANDARD
2014/01/15 SUPPL-172（补充） Approval Manufacturing (CMC) STANDARD
2014/01/09 SUPPL-171（补充） Approval Manufacturing (CMC) STANDARD
2013/08/27 SUPPL-170（补充） Approval Manufacturing (CMC) STANDARD
2011/12/23 SUPPL-169（补充） Approval Labeling-Package Insert STANDARD
2011/02/23 SUPPL-168（补充） Approval Labeling-Package Insert STANDARD
2009/10/01 SUPPL-165（补充） Approval Labeling STANDARD
2009/02/17 SUPPL-162（补充） Approval Labeling STANDARD
2007/12/14 SUPPL-161（补充） Approval Labeling STANDARD
2006/10/04 SUPPL-158（补充） Approval Labeling STANDARD
2005/09/02 SUPPL-156（补充） Approval Manufacturing (CMC)-Packaging STANDARD
2005/09/02 SUPPL-155（补充） Approval Manufacturing (CMC)-Formulation STANDARD
2005/09/02 SUPPL-154（补充） Approval Manufacturing (CMC)-Control STANDARD
2002/11/25 SUPPL-150（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
2002/11/22 SUPPL-151（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
2002/11/22 SUPPL-148（补充） Approval Manufacturing (CMC)-Packaging STANDARD
2002/11/21 SUPPL-149（补充） Approval Manufacturing (CMC)-Packaging STANDARD
2002/07/15 SUPPL-147（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
2002/02/05 SUPPL-146（补充） Approval Labeling STANDARD
2001/08/31 SUPPL-145（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/11/16 SUPPL-144（补充） Approval Manufacturing (CMC)-Packaging STANDARD
2000/05/31 SUPPL-143（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/05/26 SUPPL-142（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/05/26 SUPPL-141（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/05/01 SUPPL-140（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/02/15 SUPPL-139（补充） Approval Manufacturing (CMC)-Control STANDARD
1999/09/30 SUPPL-136（补充） Approval Labeling STANDARD
1999/05/13 SUPPL-138（补充） Approval Manufacturing (CMC)-Control STANDARD
1998/06/23 SUPPL-133（补充） Approval Labeling STANDARD
1998/02/20 SUPPL-134（补充） Approval Manufacturing (CMC)-Control STANDARD
1997/04/24 SUPPL-132（补充） Approval Manufacturing (CMC) STANDARD
1996/03/05 SUPPL-131（补充） Approval Manufacturing (CMC)-Control STANDARD
1993/02/09 SUPPL-130（补充） Approval Manufacturing (CMC)-Control STANDARD
1991/04/23 SUPPL-128（补充） Approval Labeling
1989/09/27 SUPPL-127（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1989/06/28 SUPPL-124（补充） Approval Labeling
1989/06/20 SUPPL-126（补充） Approval Labeling
1989/06/20 SUPPL-125（补充） Approval Labeling
1987/10/14 SUPPL-123（补充） Approval Labeling
1987/09/16 SUPPL-122（补充） Approval Labeling
1987/07/02 SUPPL-121（补充） Approval Labeling
1987/07/02 SUPPL-120（补充） Approval Labeling
1987/04/29 SUPPL-117（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1987/04/29 SUPPL-115（补充） Approval Labeling
1987/04/24 SUPPL-119（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/03/10 SUPPL-118（补充） Approval Manufacturing (CMC) STANDARD
1986/09/23 SUPPL-116（补充） Approval Manufacturing (CMC) STANDARD
1986/04/07 SUPPL-112（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1986/01/30 SUPPL-114（补充） Approval Labeling
1986/01/21 SUPPL-108（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1985/10/10 SUPPL-113（补充） Approval Manufacturing (CMC) STANDARD
1985/08/29 SUPPL-111（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/08/29 SUPPL-110（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/05/13 SUPPL-109（补充） Approval Labeling
1984/10/11 SUPPL-107（补充） Approval Labeling
1984/10/11 SUPPL-105（补充） Approval Labeling
1984/08/02 SUPPL-104（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1984/03/05 SUPPL-13（补充） Approval Labeling
1983/12/21 SUPPL-102（补充） Approval Labeling
1983/09/13 SUPPL-99（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/09/05 SUPPL-101（补充） Approval Labeling
1983/06/10 SUPPL-100（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/10/06 SUPPL-98（补充） Approval Manufacturing (CMC) STANDARD
1982/08/18 SUPPL-97（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1982/06/04 SUPPL-96（补充） Approval Manufacturing (CMC) STANDARD
1981/11/20 SUPPL-95（补充） Approval Labeling
1981/05/22 SUPPL-94（补充） Approval Labeling
1980/01/21 SUPPL-93（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/09/25 SUPPL-92（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1979/03/06 SUPPL-91（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/01/16 SUPPL-90（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/01/16 SUPPL-89（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/01/16 SUPPL-88（补充） Approval Labeling
1978/10/04 SUPPL-87（补充） Approval Labeling
1978/08/04 SUPPL-86（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/08/04 SUPPL-84（补充） Approval Manufacturing (CMC) STANDARD
1978/07/31 SUPPL-85（补充） Approval Labeling
1978/07/31 SUPPL-83（补充） Approval Manufacturing (CMC) STANDARD
1978/07/31 SUPPL-82（补充） Approval Labeling
1978/04/27 SUPPL-78（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/04/27 SUPPL-77（补充） Approval Labeling
1978/01/03 SUPPL-73（补充） Approval Manufacturing (CMC) STANDARD
1977/12/14 SUPPL-81（补充） Approval Labeling
1977/12/14 SUPPL-80（补充） Approval Manufacturing (CMC) STANDARD
1977/12/14 SUPPL-79（补充） Approval Labeling
1977/12/14 SUPPL-75（补充） Approval Labeling
1977/12/14 SUPPL-74（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1977/08/02 SUPPL-72（补充） Approval Labeling
1977/05/26 SUPPL-71（补充） Approval Manufacturing (CMC)-Control STANDARD
1977/05/26 SUPPL-69（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1977/04/26 SUPPL-70（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1977/02/17 SUPPL-67（补充） Approval Manufacturing (CMC)-Control STANDARD
1976/10/19 SUPPL-66（补充） Approval Labeling
1976/10/19 SUPPL-65（补充） Approval Labeling
1976/09/08 SUPPL-63（补充） Approval Manufacturing (CMC)-Control STANDARD
1976/09/08 SUPPL-59（补充） Approval Manufacturing (CMC)-Control STANDARD
1976/09/08 SUPPL-58（补充） Approval Manufacturing (CMC)-Control STANDARD
1976/09/08 SUPPL-57（补充） Approval Manufacturing (CMC)-Control STANDARD
1976/09/03 SUPPL-52（补充） Approval Labeling
1976/09/03 SUPPL-51（补充） Approval Labeling
1976/06/25 SUPPL-54（补充） Approval Labeling
1976/05/28 SUPPL-55（补充） Approval Manufacturing (CMC)-Control STANDARD
1976/01/09 SUPPL-48（补充） Approval Manufacturing (CMC)-Control STANDARD
1975/09/04 SUPPL-47（补充） Approval Labeling
1975/09/04 SUPPL-46（补充） Approval Labeling
1975/09/04 SUPPL-45（补充） Approval Labeling
1975/09/04 SUPPL-44（补充） Approval Labeling
1975/09/04 SUPPL-43（补充） Approval Labeling
1975/09/04 SUPPL-42（补充） Approval Labeling
1975/04/23 SUPPL-39（补充） Approval Manufacturing (CMC)-Control STANDARD
1975/03/24 SUPPL-38（补充） Approval Labeling
与本品相关的专利信息（来自FDA橙皮书Orange Book）
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
无
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
无
与本品治疗等效的药品
>>>活性成分:HEPARIN SODIUM; 剂型/给药途径:INJECTABLE;INJECTION; 规格:1,000 UNITS/ML; 治疗等效代码:AP<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
017037 001 NDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HIKMA
017029 001 NDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
017029 013 NDA HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription Yes Yes AP 1985/12/05 FRESENIUS KABI USA
017029 010 NDA HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription Yes Yes AP 1986/04/28 FRESENIUS KABI USA
090571 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2009/08/31 HOSPIRA INC
090808 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2010/06/30 SAGENT PHARMS
090810 001 ANDA HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2010/06/30 SAGENT PHARMS
091682 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2011/06/08 PLANO PHARMS
202732 001 ANDA HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2014/06/12 SHENZHEN TECHDOW
202957 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2014/06/12 SHENZHEN TECHDOW
203851 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2017/11/30 NORVIUM BIOSCIENCE
211005 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2018/12/14 NANJING KING-FRIEND
211007 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2019/05/28 NANJING KING-FRIEND
205323 002 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2019/11/18 GLAND
214804 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2020/12/29 BE PHARMS
>>>活性成分:HEPARIN SODIUM; 剂型/给药途径:INJECTABLE;INJECTION; 规格:5,000 UNITS/ML; 治疗等效代码:AP<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
017037 002 NDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HIKMA
017651 006 NDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
017029 014 NDA HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription Yes Yes AP 1985/12/05 FRESENIUS KABI USA
090571 002 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2009/08/31 HOSPIRA INC
090808 002 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2010/06/30 SAGENT PHARMS
091682 002 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2011/06/08 PLANO PHARMS
202733 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2014/06/12 SHENZHEN TECHDOW
202957 002 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2014/06/12 SHENZHEN TECHDOW
206552 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2016/06/10 FRESENIUS KABI USA
205323 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2017/02/06 GLAND
203851 002 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2017/11/30 NORVIUM BIOSCIENCE
211007 002 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2019/05/28 NANJING KING-FRIEND
212061 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2020/07/15 NANJING KING-FRIEND
>>>活性成分:HEPARIN SODIUM; 剂型/给药途径:INJECTABLE;INJECTION; 规格:10,000 UNITS/ML; 治疗等效代码:AP<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
017037 003 NDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HIKMA
017029 003 NDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
017029 015 NDA HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription Yes Yes AP 1985/12/05 FRESENIUS KABI USA
089522 001 ANDA HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription No No AP 1987/05/04 HOSPIRA
090571 003 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription No No AP 2009/08/31 HOSPIRA INC
090808 003 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription No No AP 2010/06/30 SAGENT PHARMS
017029 019 NDA HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription Yes Yes AP 2010/11/22 FRESENIUS KABI USA
201002 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription No No AP 2011/06/08 PLANO PHARMS
203198 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription No No AP 2014/06/12 SHENZHEN TECHDOW
203851 003 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription No No AP 2017/11/30 NORVIUM BIOSCIENCE
211007 003 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription No No AP 2019/05/28 NANJING KING-FRIEND
212060 001 ANDA HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription No No AP 2020/04/02 NANJING KING-FRIEND
214839 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription No No AP 2020/12/29 BE PHARMS
>>>活性成分:HEPARIN SODIUM; 剂型/给药途径:INJECTABLE;INJECTION; 规格:5,000 UNITS/0.5ML; 治疗等效代码:AP<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
017037 013 NDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/0.5ML Prescription No No AP 1986/04/07 HIKMA
208827 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/0.5ML Discontinued No No AP 2018/11/19 B BRAUN MEDICAL
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