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chgj2000

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ronalbeck

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chgj2000(½ð±Ò+1):лл£¡ 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   

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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
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iamzane

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chgj2000(½ð±Ò+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.

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chgj2000(½ð±Ò+1): 2011-01-07 15:38:25
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