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
提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 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 |
2020/01/14 |
SUPPL-187(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2019/05/18 |
SUPPL-183(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2017/05/09 |
SUPPL-178(补充) |
Approval |
Labeling |
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 |
STANDARD
|
|
|
2011/02/23 |
SUPPL-168(补充) |
Approval |
Labeling |
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) |
STANDARD
|
|
|
2005/09/02 |
SUPPL-155(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2005/09/02 |
SUPPL-154(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/11/25 |
SUPPL-150(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/11/22 |
SUPPL-151(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/11/22 |
SUPPL-148(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/11/21 |
SUPPL-149(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/07/15 |
SUPPL-147(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/02/05 |
SUPPL-146(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/08/31 |
SUPPL-145(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/11/16 |
SUPPL-144(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/05/31 |
SUPPL-143(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/05/26 |
SUPPL-142(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/05/26 |
SUPPL-141(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/05/01 |
SUPPL-140(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/02/15 |
SUPPL-139(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/09/30 |
SUPPL-136(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/05/13 |
SUPPL-138(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/06/23 |
SUPPL-133(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/02/20 |
SUPPL-134(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/04/24 |
SUPPL-132(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/03/05 |
SUPPL-131(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1993/02/09 |
SUPPL-130(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/04/23 |
SUPPL-128(补充) |
Approval |
Labeling |
|
|
|
1989/09/27 |
SUPPL-127(补充) |
Approval |
Manufacturing (CMC) |
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) |
STANDARD
|
|
|
1987/04/29 |
SUPPL-115(补充) |
Approval |
Labeling |
|
|
|
1987/04/24 |
SUPPL-119(补充) |
Approval |
Manufacturing (CMC) |
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) |
STANDARD
|
|
|
1986/01/30 |
SUPPL-114(补充) |
Approval |
Labeling |
|
|
|
1986/01/21 |
SUPPL-108(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/10/10 |
SUPPL-113(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/08/29 |
SUPPL-111(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/08/29 |
SUPPL-110(补充) |
Approval |
Manufacturing (CMC) |
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) |
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) |
STANDARD
|
|
|
1983/09/05 |
SUPPL-101(补充) |
Approval |
Labeling |
|
|
|
1983/06/10 |
SUPPL-100(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/10/06 |
SUPPL-98(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/08/18 |
SUPPL-97(补充) |
Approval |
Manufacturing (CMC) |
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) |
STANDARD
|
|
|
1979/09/25 |
SUPPL-92(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/03/06 |
SUPPL-91(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/01/16 |
SUPPL-90(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/01/16 |
SUPPL-89(补充) |
Approval |
Manufacturing (CMC) |
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) |
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) |
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) |
STANDARD
|
|
|
1977/08/02 |
SUPPL-72(补充) |
Approval |
Labeling |
|
|
|
1977/05/26 |
SUPPL-71(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/05/26 |
SUPPL-69(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/04/26 |
SUPPL-70(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/02/17 |
SUPPL-67(补充) |
Approval |
Manufacturing (CMC) |
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) |
STANDARD
|
|
|
1976/09/08 |
SUPPL-59(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/09/08 |
SUPPL-58(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/09/08 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
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) |
STANDARD
|
|
|
1976/01/09 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
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) |
STANDARD
|
|
|
1975/03/24 |
SUPPL-38(补充) |
Approval |
Labeling |
|
|
|
1972/03/22 |
ORIG-1(原始申请) |
Approval |
Type 5 - New Formulation or New Manufacturer |
STANDARD
|
|
|
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 | RLD | RS | TE 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
|
SANDOZ |
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
|
MYLAN LABS LTD |
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 | RLD | RS | TE 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
|
SANDOZ |
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
|
MYLAN LABS LTD |
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 | RLD | RS | TE 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
|
SANDOZ |
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
|
MYLAN LABS LTD |
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 | RLD | RS | TE 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 |
Prescription |
No |
No |
AP |
2018/11/19
|
B BRAUN MEDICAL INC |