Visitor Monitoring Drug History: GENOTROPIN PRESERVATIVE FREE
 
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: GENOTROPIN PRESERVATIVE FREE
FDA Application No: (NDA) 020280
Active Ingredient(s): SOMATROPIN RECOMBINANT
Company: PHARMACIA AND UPJOHN
 
Label History
 
View the label approved on March 15, 2007 for GENOTROPIN PRESERVATIVE FREE, (NDA) 020280


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
3/14/2007 057Labeling Revision Letter
Label 
7/22/2007 055Control Supplement Letter
Label 
8/10/2007 055Control Supplement Letter
Label 
4/27/2006 049New or Modified Indication Letter
Label 
10/31/2003 044Labeling Revision Letter 
11/5/2002 041Control Supplement  
5/12/2003 040Control Supplement Letter
Label 
8/15/2002 039Manufacturing Change or Addition  
3/28/2003 038Manufacturing Change or Addition Letter 
1/29/2002 037Control Supplement  
9/21/2001 036Manufacturing Change or Addition  
7/9/2001 035Manufacturing Change or Addition  
1/26/2001 034Control Supplement  
12/8/2000 033Manufacturing Change or Addition  
11/7/2000 032Manufacturing Change or Addition  
7/25/2001 031New or Modified Indication Letter
Label
Review 
7/21/2000 030Control Supplement  
10/5/2000 029Manufacturing Change or Addition  
8/18/2000 028Labeling Revision  
7/31/2000 027Control Supplement  
5/26/2000 026Control Supplement  
7/11/2000 025Labeling Revision  
5/12/2000 024Control Supplement  
6/20/2000 023New or Modified Indication Letter 
4/11/2000 022Manufacturing Change or Addition  
7/11/2000 021Manufacturing Change or Addition  
1/19/2000 020Control Supplement  
4/30/1999 018Control Supplement  
4/27/1999 017Control Supplement  
2/24/1999 016Manufacturing Change or Addition  
7/30/1998 015Control Supplement  
4/30/1999 013Control Supplement  
8/18/1998 012Control Supplement  
8/4/1998 011Control Supplement  
1/5/1998 010Control Supplement  
1/27/1998 009Control Supplement  
10/31/1997 008New or Modified Indication  
10/23/1996 007Control Supplement  
11/19/1996 006Control Supplement  
7/15/1996 005Manufacturing Change or Addition  
5/24/1996 004Control Supplement  
4/19/1996 003Labeling Revision  
4/24/1996 002Manufacturing Change or Addition  
12/20/1995 001Labeling Revision  
8/24/1995 000Approval  
 
There are no Therapeutic Equivalents
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