Visitor Monitoring Drug History: SAIZEN
 
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: SAIZEN
FDA Application No: (NDA) 019764
Active Ingredient(s): SOMATROPIN RECOMBINANT
Company: EMD SERONO
 
Label History
 
View the label approved on August 30, 2007 for SAIZEN, (NDA) 019764


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 039Labeling Revision Letter
Label 
8/22/2007 037Labeling Revision Letter
Label 
3/5/2007 034Labeling Revision Letter
Label 
1/16/2007 030Control Supplement Letter
Label 
7/9/2004 025Package Change Letter
Label 
7/1/2003 023Labeling Revision Letter
Label 
11/1/2004 020New or Modified Indication Letter
Label 
10/17/2002 019Control Supplement  
12/31/2002 018Manufacturing Change or Addition  
12/20/2002 017Manufacturing Change or Addition  
12/3/2001 016Control Supplement  
9/6/2002 015Control Supplement  
7/19/2001 014Manufacturing Change or Addition  
5/3/2001 013Manufacturing Change or Addition  
8/17/2000 012Control Supplement  
7/19/2000 011Control Supplement  
4/11/2000 010Manufacturing Change or Addition  
7/26/2000 009Labeling Revision  
6/7/2000 008Manufacturing Change or Addition  
3/28/2000 007Manufacturing Change or Addition  
4/4/2000 006Labeling Revision  
2/11/1999 005Manufacturing Change or Addition  
7/9/1998 004Manufacturing Change or Addition  
8/29/2000 003Control Supplement  
1/21/1998 002Manufacturing Change or Addition  
12/9/1996 001Labeling Revision  
10/8/1996 000Approval  
 
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