Visitor Monitoring Drug History: TRANXENE SD
 
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Label and Approval History

Drug Name: TRANXENE SD
FDA Application No: (NDA) 017105
Active Ingredient(s): CLORAZEPATE DIPOTASSIUM
Company: OVATION PHARMS
 
Label History
 
Labels are not available on this site for TRANXENE SD, (NDA) 017105
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
3/13/2003 070Labeling Revision Letter
Review 
8/28/2002 069Control Supplement  
5/8/1998 068Package Change  
8/4/1999 067Control Supplement  
11/5/1996 066Control Supplement  
11/8/1988 064Control Supplement  
2/7/2002 062Labeling Revision Letter
Review 
11/5/1987 060Package Change  
2/7/2002 059Labeling Revision Letter
Review 
8/13/1987 058Control Supplement  
1/8/1987 057Control Supplement  
11/14/1986 056Control Supplement  
8/29/1986 055Control Supplement  
8/26/1985 054Control Supplement  
6/16/1986 053Control Supplement  
2/27/1984 052Control Supplement  
10/28/1980 045Control Supplement  
9/8/1980 044Formulation Revision  
7/14/1980 043Labeling Revision  
12/12/1979 040Labeling Revision  
1/29/1981 039General Efficacy (MarkIV)  
5/31/1979 038Control Supplement  
6/5/1979 037Formulation Revision  
6/7/1979 036Manufacturing Change or Addition  
6/7/1979 035Control Supplement  
6/7/1979 034Control Supplement  
12/6/1978 033Package Change  
4/17/1978 032Formulation Revision  
5/5/1978 031Formulation Revision  
10/21/1977 030Labeling Revision  
7/9/1979 029Control Supplement  
10/20/1977 028Formulation Revision  
12/21/1976 025Manufacturing Change or Addition  
1/4/1977 024Manufacturing Change or Addition  
12/21/1976 023Manufacturing Change or Addition  
3/10/1980 022Manufacturing Change or Addition  
5/7/1976 021Formulation Revision  
3/18/1977 019Control Supplement  
7/30/1976 017Control Supplement  
8/4/1976 016Labeling Revision  
8/4/1976 015Control Supplement  
9/10/1975 014Control Supplement  
11/5/1975 013Labeling Revision  
11/13/1975 009Control Supplement  
3/31/1975 008Control Supplement  
6/23/1972 000Approval  
 
There are no Therapeutic Equivalents
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