Visitor Monitoring Drug History: MAXZIDE-25
 
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Label and Approval History

Drug Name: MAXZIDE-25
FDA Application No: (NDA) 019129
Active Ingredient(s): HYDROCHLOROTHIAZIDE; TRIAMTERENE
Company: MYLAN BERTEK
 
Label History
 
Labels are not available on this site for MAXZIDE25, (NDA) 019129
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
2/2/2001 030Control Supplement  
7/16/1999 029Package Change  
1/10/1997 028Labeling Revision  
9/12/1996 027Manufacturing Change or Addition  
7/1/1992 026Labeling Revision  
6/6/1991 025Package Change  
2/6/1989 024Labeling Revision  
7/21/1988 023Control Supplement  
6/29/1988 022Labeling Revision  
5/13/1988 021Manufacturing Change or Addition  
2/25/1988 020Control Supplement  
10/28/1987 019Manufacturing Change or Addition  
11/13/1987 018Manufacturing Change or Addition  
8/4/1987 016Manufacturing Change or Addition  
7/29/1987 015Expiration Date Change  
2/9/1990 014Labeling Revision  
4/14/1987 013Expiration Date Change  
7/8/1986 011Labeling Revision  
1/27/1986 010Control Supplement  
5/13/1988 008New Dosage Regimen  
10/8/1985 007Expiration Date Change  
8/16/1985 006Labeling Revision  
5/10/1985 005Control Supplement  
4/26/1985 004Formulation Revision  
4/1/1985 003Package Change  
5/3/1985 001Labeling Revision  
10/22/1984 000Approval  
 
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