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celtia

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Sep 20 12 11:34 AM

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New and Generic Drug Approvals


Visit Drugs@FDA1 to Search Drug Approval Reports by Month

We have changed the format of this page. You will now find approvals listed under the date of the action, rather than the date we added the information to the website.





September 19, 2012

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Doxil2 doxorubicin hydrochloride Injectable, Liposomal; Injection Janssen R and D Labeling Revision

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jonpi

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Sep 21 12 11:45 PM

Buen dia S.

Manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146
Manufactured for: Janssen Products, LP Horsham, PA 19044 © Janssen Products, LP 2010
Revised September 2012
 

Click on a column header to re-sort the table:

Action
Date

Supplement
Number

Approval
Type
Letters,
Reviews,
Labels,
Patient Package Insert  
Note
09/19/2012  043  Labeling Revision   Label (PDF12    
06/10/2008  033  Accelerated Approval   Label (PDF13
Letter (PDF14
Summary Review (PDF)15  
 
05/17/2007  029  New or Modified Indication   Label (PDF16
Letter (PDF17  
 
05/17/2007  028  Labeling Revision   Label (PDF18
Letter (PDF19  
 
01/28/2005  020  Accelerated Approval   Label (PDF20
Letter (PDF21  
 
10/27/2004  019  Efficacy Supplement with Clinical Data to Support   Label (PDF22
Letter (PDF23
Review (PDF)24  
 
12/17/2002  016  Control Supplement     This supplement type does
not usually require new labeling.  
08/09/2002  014  Package Change     Label is not available
on this site.  
04/18/2002  012  Control Supplement     This supplement type does
not usually require new labeling.  
01/10/2002  010  Labeling Revision   Letter (PDF25   Label is not available
on this site.  
06/13/2000  008  Package Change     Label is not available
on this site.  
03/30/2000  007  Manufacturing Change or Addition     This supplement type does
not usually require new labeling.  
06/28/1999  006  New or Modified Indication   Label (PDF26
Letter (PDF27  
 
03/31/1998  005  Control Supplement     This supplement type does
not usually require new labeling.  
07/31/1997  004  Labeling Revision     Label is not available
on this site.  
07/10/1996  002  Expiration Date Change     Label is not available
on this site.  
03/08/1996  001  Labeling Revision     Label is not available
on this site.  
11/17/1995  000  Approval     Label is not available
on this site.  

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salut


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