Visitor Monitoring Drug History: PARAGARD T 380A
 
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Label and Approval History

Drug Name: PARAGARD T 380A
FDA Application No: (NDA) 018680
Active Ingredient(s): COPPER
Company: DURAMED PHARMS BARR
 
Label History
 
View the label approved on September 8, 2005 for PARAGARD T 380A, (NDA) 018680


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
9/1/2005 060Efficacy Supplement with Clinical Data to Support Letter
Label 
4/22/2003 057Labeling Revision Letter 
9/27/2001 056Manufacturing Change or Addition  
8/24/2001 055Labeling Revision Label 
9/20/2000 054Manufacturing Change or Addition  
4/25/2000 053Control Supplement  
3/27/2000 052Manufacturing Change or Addition  
12/14/1999 051Control Supplement  
7/23/1999 050Manufacturing Change or Addition  
7/23/1999 049Manufacturing Change or Addition  
2/2/1999 048Control Supplement  
2/2/1999 047Control Supplement  
5/29/1998 046Manufacturing Change or Addition  
5/29/1998 045Control Supplement  
7/7/1998 044Control Supplement  
7/7/1998 043Control Supplement  
2/10/1998 042Control Supplement  
11/3/1997 041Control Supplement  
10/9/1997 040Control Supplement  
6/4/1997 039Control Supplement  
3/13/1997 038Control Supplement  
2/14/1997 037Control Supplement  
5/17/1996 036Control Supplement  
4/12/1996 035Control Supplement  
4/12/1996 034Control Supplement  
1/18/1996 033Package Change  
1/24/1996 032Control Supplement  
7/24/1995 030Manufacturing Change or Addition  
5/19/1994 026New Dosage Regimen  
6/17/1993 025Expiration Date Change  
11/25/1991 023Labeling Revision  
11/20/1991 021Labeling Revision  
11/25/1991 020Package Change  
11/25/1991 019Control Supplement  
7/17/1991 017Manufacturing Change or Addition  
8/13/1991 016New Dosage Regimen  
5/3/1991 015Labeling Revision  
11/25/1991 014Control Supplement  
3/22/1991 013Control Supplement  
9/24/1990 012Labeling Revision  
7/24/1989 011Labeling Revision  
7/24/1989 010Labeling Revision  
3/1/1989 009Labeling Revision  
7/17/1989 008New Dosage Regimen  
10/17/1988 006Labeling Revision  
11/18/1988 005Control Supplement  
4/29/1988 003Labeling Revision  
11/15/1984 000Approval  
 
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