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chgj2000

铜虫 (小有名气)


[交流] 【求助】求申报资料

Feridex能帮我查下它的申报资料吗(FDA)
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ronalbeck

银虫 (正式写手)


chgj2000(金币+1):谢谢! 2010-11-03 09:53:14
Drug Details

Drug Name(s) FERIDEX I.V. (Brand Name Drug)
FDA Application No. (NDA) 020416
Active Ingredient(s) FERUMOXIDES
Company AMAG PHARMS INC
Original Approval or Tentative Approval Date August 30, 1996
Chemical Type 1  New molecular entity (NME)

Review Classification S  Standard review drug   


There are no Therapeutic Equivalents
Labels are not available

Approval History, Letters, Reviews, and Related Documents



Products on Application (NDA) #020416
    Click on a column header to re-sort the table:  

Drug Name  
Active Ingredients  
Strength  
Dosage Form/Route  
Marketing
Status  
RLD  
TE
Code  
FERIDEX I.V.  FERUMOXIDES  EQ 11.2MG IRON/ML  INJECTABLE; INJECTION  Prescription  Yes None   

这个药没有说明书啊!
Label Information

What information does a label include?
Note: Not all labels are available in electronic format from FDA.

Labels are not available on this site for FERIDEX I.V., NDA no. 020416



Approval History
NDA 020416

Note: Not all reviews are available in electronic format from FDA.
Older labels are for historical information only, and should not be used for clinical purposes.
Approval dates can only be verified from 1984 to the present.


Click on a column header to re-sort the table:
  
Action
Date  
Supplement
Number  
Approval
Type  Letters,
Reviews,
Labels,
Patient Package Insert   Note
10/11/1996  001  Labeling Revision      Label is not available
on this site.   
08/30/1996  000  Approval      Label is not available
on this site.   


Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players





There are no Therapeutic Equivalents
2楼2010-11-03 08:44:59
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chgj2000

铜虫 (小有名气)


哪里才能查到国外药物的申报资料,如何查,详细点啊
3楼2010-11-04 11:18:25
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iamzane

至尊木虫 (著名写手)

chgj2000(金币+1): 2011-01-07 11:29:04
http://www.amagpharma.com/products/feridex_iv.php

In November 2008, the Company ceased manufacturing of Feridex and does not intend to continue its commercialization. The Company has terminated agreements with all of our Feridex marketing partners including Bayer Healthcare Pharmaceuticals and TaeJoon Pharmaceuticals Co., Ltd.

人家都不卖了啊。
4楼2011-01-07 09:10:31
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chgj2000

铜虫 (小有名气)


我只想借鉴他的申报资料,跟他的产品是两码事情,谢谢提醒。若能有详细的申报资料,望不吝赠予我啊
5楼2011-01-07 11:31:04
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zly9912

木虫 (著名写手)

chgj2000(金币+1): 2011-01-07 15:38:25
申报资料弄不到的吧,这个是保密的呀。。。
6楼2011-01-07 13:28:01
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丝瓜

铜虫 (小有名气)

chgj2000(金币+1): 2011-01-07 15:38:21
保密的,弄不到
7楼2011-01-07 15:16:56
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chgj2000

铜虫 (小有名气)


能不能通过非正规途径弄到呢
8楼2011-01-07 15:38:49
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