Visitor Monitoring Drug History: LAC-HYDRIN
 
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Label and Approval History

Drug Name: LAC-HYDRIN
FDA Application No: (NDA) 019155
Active Ingredient(s): AMMONIUM LACTATE
Company: RANBAXY
 
Label History
 
Labels are not available on this site for LACHYDRIN, (NDA) 019155
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
4/29/2004 020Labeling Revision Letter
Review 
4/29/2004 019Labeling Revision Letter
Review 
5/20/1998 018Manufacturing Change or Addition  
12/8/1997 017Control Supplement  
12/8/1997 016Control Supplement  
5/8/1995 013Control Supplement  
5/5/1995 012Control Supplement  
1/4/1995 011Formulation Revision  
2/19/1993 010Package Change  
7/16/1992 009Control Supplement  
3/26/1992 008Manufacturing Change or Addition  
11/19/1990 007Control Supplement  
9/15/1989 006Control Supplement  
2/19/1988 005Control Supplement  
6/18/1987 004Package Change  
3/27/1986 003Labeling Revision  
8/9/1985 002Control Supplement  
8/9/1985 001Manufacturing Change or Addition  
4/24/1985 000Approval  
 
Therapeutic Equivalents
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