HEPARIN SODIUM_美国FDA药品数据库_药药网

HEPARIN SODIUM--

企业名称

申请类型

NDA--新药申请

产品信息

商品名

TEcode

产品号

申请类型

活性成分

剂型/给药途径

规格/剂量

是否参比药物

是否生物等效

INJECTABLE;INJECTION

1,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION

5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION

7,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION

10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION

15,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION

20,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION

2,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION

5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

批准历史，通知信，药品说明书，综述等审批信息

批准日期

申请类型

申请提交号

审查批准结论

申请内容分类

审评分类（优先审评;罕用药状态）

通知信、综述、标签、说明书

备注

1974/5/28 0:00:00

ORIG

1

AP

Type 3 - New Dosage Form

PRIORITY

1975/3/28 0:00:00

SUPPL

3

AP

Manufacturing (CMC)

PRIORITY

1975/10/17 0:00:00

SUPPL

5

AP

Manufacturing (CMC)

PRIORITY

1975/12/12 0:00:00

SUPPL

4

AP

Manufacturing (CMC)

PRIORITY

1976/12/29 0:00:00

SUPPL

6

AP

Manufacturing (CMC)

PRIORITY

1978/2/2 0:00:00

SUPPL

8

AP

Manufacturing (CMC)

PRIORITY

1978/2/2 0:00:00

SUPPL

7

AP

Manufacturing (CMC)

PRIORITY

1978/7/3 0:00:00

SUPPL

10

AP

Labeling

1978/7/3 0:00:00

SUPPL

9

AP

Manufacturing (CMC)

PRIORITY

1978/10/4 0:00:00

SUPPL

11

AP

Labeling

1980/7/2 0:00:00

SUPPL

13

AP

Manufacturing (CMC)

PRIORITY

1980/7/2 0:00:00

SUPPL

12

AP

Manufacturing (CMC)

PRIORITY

1981/5/14 0:00:00

SUPPL

14

AP

Manufacturing (CMC)

PRIORITY

1982/7/30 0:00:00

SUPPL

16

AP

Manufacturing (CMC)

PRIORITY

1983/5/25 0:00:00

SUPPL

17

AP

Manufacturing (CMC)

PRIORITY

1983/8/29 0:00:00

SUPPL

18

AP

Labeling

1983/10/19 0:00:00

SUPPL

19

AP

Labeling

1986/4/7 0:00:00

SUPPL

15

AP

Labeling

1987/3/5 0:00:00

SUPPL

22

AP

Labeling

1987/4/14 0:00:00

SUPPL

23

AP

Manufacturing (CMC)

PRIORITY

1987/7/29 0:00:00

SUPPL

24

AP

Manufacturing (CMC)

PRIORITY

1989/6/29 0:00:00

SUPPL

28

AP

Labeling

1989/7/13 0:00:00

SUPPL

29

AP

Labeling

1990/7/20 0:00:00

SUPPL

31

AP

Labeling

1991/2/28 0:00:00

SUPPL

25

AP

Manufacturing (CMC)

PRIORITY

1993/6/14 0:00:00

SUPPL

32

AP

Manufacturing (CMC)

PRIORITY

1993/10/20 0:00:00

SUPPL

33

AP

Manufacturing (CMC)

PRIORITY

1996/5/20 0:00:00

SUPPL

35

AP

Manufacturing (CMC)

PRIORITY

1997/3/5 0:00:00

SUPPL

36

AP

Labeling

STANDARD

2000/9/6 0:00:00

SUPPL

38

AP

Labeling

STANDARD

2018/3/27 0:00:00

SUPPL

39

AP

Labeling

STANDARD

2024/10/24 0:00:00

SUPPL

40

AP

Labeling

STANDARD

2018-01-30 00:00:00

SUPPL

38

AP

2018-01-30 00:00:00

SUPPL

38

AP

2018-04-11 00:00:00

SUPPL

39

AP

2018-04-12 00:00:00

SUPPL

39

AP

2024-10-25 00:00:00

SUPPL

40

AP

2024-10-28 00:00:00

SUPPL

40

AP

与本品相关的专利信息（来自FDA橙皮书Orange Book）

类型

关联产品号

专利号

专利过期日

中否物质专利

是否产品专利

专利用途代码

退市请求

与本品相关的市场独占权保护信息

类型

产品号

独占权代码

与本品治疗等效的药品

申请号

商品名

TEcode

产品号

申请类型

活性成分

剂型/给药途径

规格/剂量

是否参比药物

是否生物等效

INJECTABLE;INJECTION

5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION

5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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