Visitor Monitoring Drug History: GOLYTELY
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: GOLYTELY
FDA Application No: (NDA) 019011
Active Ingredient(s): POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, ANHYDROUS
Company: BRAINTREE
 
Label History
 
Labels are not available on this site for GOLYTELY, (NDA) 019011
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
9/19/2002 015Labeling Revision Letter 
2/23/2001 014Manufacturing Change or Addition  
10/7/1999 013Formulation Revision  
3/25/1999 012Formulation Revision  
6/3/1997 011Manufacturing Change or Addition  
11/4/1996 010Manufacturing Change or Addition  
10/30/1995 009Package Change  
3/24/1993 008Labeling Revision  
3/24/1993 007Labeling Revision  
9/17/1992 006Labeling Revision  
8/20/1992 005Labeling Revision  
6/2/1992 004Package Change  
11/5/1986 003Labeling Revision  
4/19/1985 002Labeling Revision  
2/22/1985 001Labeling Revision  
7/13/1984 000Approval  
 
There are no Therapeutic Equivalents
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