Visitor Monitoring Drug History: DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
 
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Label and Approval History

Drug Name: DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
FDA Application No: (NDA) 018379
Active Ingredient(s): CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Company: FRESENIUS MEDCL
 
Label History
 
Labels are not available on this site for DELFLEXLM W DEXTROSE 2.5 IN PLASTIC CONTAINER, (NDA) 018379
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
9/27/1999 096Manufacturing Change or Addition  
11/9/2001 095Formulation Revision  
8/14/1997 094Manufacturing Change or Addition  
7/3/1996 093Control Supplement  
11/1/1996 092Control Supplement  
2/7/1996 091Manufacturing Change or Addition  
1/23/1996 089Control Supplement  
8/30/1991 085Package Change  
1/28/1992 084Package Change  
9/10/1991 083Control Supplement  
1/11/1990 081Manufacturing Change or Addition  
8/1/1990 080Expiration Date Change  
2/22/1990 079Manufacturing Change or Addition  
6/14/1989 078Control Supplement  
2/24/1988 077Formulation Revision  
2/2/1988 076Formulation Revision  
6/24/1988 074Labeling Revision  
6/24/1988 073Manufacturing Change or Addition  
6/24/1988 072Labeling Revision  
6/24/1988 071Manufacturing Change or Addition  
7/30/1987 069Control Supplement  
11/26/1986 068Control Supplement  
8/8/1986 067Control Supplement  
2/11/1987 066Control Supplement  
2/11/1987 065Control Supplement  
4/28/1987 064Labeling Revision  
4/28/1987 063Control Supplement  
2/27/1987 062Labeling Revision  
2/27/1987 061Control Supplement  
2/21/1986 060Control Supplement  
12/6/1985 059Control Supplement  
2/26/1986 058Control Supplement  
2/26/1986 057Control Supplement  
1/18/1986 056Labeling Revision  
1/18/1986 055Package Change  
1/18/1986 054Labeling Revision  
1/18/1986 053Package Change  
1/31/1986 052Control Supplement  
10/2/1985 051Labeling Revision  
10/2/1985 050Control Supplement  
10/24/1985 049Labeling Revision  
10/24/1985 048Control Supplement  
10/2/1985 047Control Supplement  
9/6/1985 046Control Supplement  
10/2/1985 045Manufacturing Change or Addition  
10/2/1985 044Labeling Revision  
10/2/1985 043Control Supplement  
12/10/1985 042Labeling Revision  
12/10/1985 041Control Supplement  
10/22/1984 040Control Supplement  
9/26/1985 039Package Change  
5/1/1985 037Control Supplement  
10/29/1985 036Package Change  
11/28/1984 035Control Supplement  
9/8/1984 034Control Supplement  
6/8/1984 033Control Supplement  
6/22/1989 032Control Supplement  
10/17/1984 031Control Supplement  
3/21/1984 030Control Supplement  
3/15/1985 029Control Supplement  
1/25/1984 028Package Change  
1/25/1984 027Control Supplement  
2/17/1984 026Control Supplement  
7/26/1982 025Control Supplement  
7/21/1982 024Control Supplement  
3/1/1984 023Control Supplement  
10/10/1984 022Labeling Revision  
10/10/1984 021Package Change  
7/5/1983 020Control Supplement  
7/4/1982 019Labeling Revision  
7/4/1982 018Formulation Revision  
6/9/1982 017Expiration Date Change  
7/7/1982 016Labeling Revision  
7/7/1982 015Control Supplement  
8/5/1982 014Labeling Revision  
8/5/1982 013Control Supplement  
2/1/1982 012Control Supplement  
1/8/1982 011Control Supplement  
3/11/1982 010Labeling Revision  
3/11/1982 009Formulation Revision  
6/9/1982 008Control Supplement  
10/1/1981 007Labeling Revision  
4/23/1981 005Control Supplement  
9/16/1981 004Control Supplement  
4/9/1982 003Practioner Draft Labeling  
1/19/1981 002Control Supplement  
10/31/1980 001Control Supplement  
9/3/1980 000Approval  
 
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