Visitor Monitoring Drug History: SEROSTIM
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: SEROSTIM
FDA Application No: (NDA) 020604
Active Ingredient(s): SOMATROPIN RECOMBINANT
Company: EMD SERONO
 
Label History
 
View the label approved on August 30, 2007 for SEROSTIM, (NDA) 020604


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
8/27/2007 044Labeling Revision Letter
Letter
Label
Label 
8/30/2007 044Labeling Revision Letter
Letter
Label
Label 
7/13/2007 040Labeling Revision Letter
Label 
11/27/2006 035Control Supplement Letter
Label 
9/21/2006 034Control Supplement Letter
Label 
8/24/2005 031Labeling Revision Letter
Label 
7/9/2004 030Package Change Letter
Label 
2/11/2005 029Formulation Revision Letter
Label 
8/29/2003 027Accelerated Approval Letter
Label 
12/1/2003 026Labeling Revision Letter
Label
Review 
10/17/2002 023Control Supplement  
12/31/2002 022Manufacturing Change or Addition  
12/20/2002 021Manufacturing Change or Addition  
12/3/2001 020Control Supplement  
11/19/2001 019Control Supplement  
9/6/2002 018Control Supplement  
7/19/2001 017Manufacturing Change or Addition  
9/6/2001 016Labeling Revision  
5/3/2001 015Manufacturing Change or Addition  
6/13/2001 014Labeling Revision  
8/17/2000 013Control Supplement  
7/19/2000 012Control Supplement  
4/11/2000 011Manufacturing Change or Addition  
10/27/2000 010Labeling Revision  
7/17/2000 009Labeling Revision  
9/18/2000 008Expiration Date Change  
3/28/2000 007Manufacturing Change or Addition  
4/4/2000 006Labeling Revision  
7/9/1998 005Control Supplement  
7/9/1998 004Manufacturing Change or Addition  
1/21/1998 003Manufacturing Change or Addition  
7/25/1997 002Control Supplement  
1/16/1998 001Labeling Revision  
8/23/1996 000Approval  
 
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