Visitor Monitoring Drug History: ROBINUL
 
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: ROBINUL
FDA Application No: (NDA) 017558
Active Ingredient(s): GLYCOPYRROLATE
Company: BAXTER HLTHCARE
 
Label History
 
View the label approved on May 27, 2005 for ROBINUL, (NDA) 017558


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
5/26/2005 053Labeling Revision Letter
Label 
11/5/2004 050Labeling Revision Letter 
11/5/2004 049Labeling Revision Letter 
6/30/2003 048Labeling Revision Letter 
6/30/2003 047Labeling Revision Letter 
11/5/2004 046Labeling Revision Letter 
11/5/2004 045Labeling Revision Letter 
4/26/2001 043Manufacturing Change or Addition  
2/13/1998 042Manufacturing Change or Addition  
9/6/1988 041Formulation Revision  
6/6/1988 040Control Supplement  
4/18/1988 039Control Supplement  
3/16/1987 038Control Supplement  
6/12/1986 037Control Supplement  
6/12/1986 036Control Supplement  
7/24/1986 035Control Supplement  
3/2/1983 030Control Supplement  
3/2/1983 029Control Supplement  
3/4/1982 028Manufacturing Change or Addition  
1/19/1982 027Control Supplement  
11/6/1981 026Expiration Date Change  
9/24/1981 025Control Supplement  
10/22/1981 024Labeling Revision  
10/22/1981 023Labeling Revision  
10/22/1981 022Control Supplement  
9/26/1980 019Control Supplement  
12/4/1980 018Labeling Revision  
4/1/1980 017Labeling Revision  
4/1/1980 016Control Supplement  
4/1/1980 015Labeling Revision  
4/1/1980 014Control Supplement  
11/30/1978 011Control Supplement  
8/17/1978 010Labeling Revision  
8/17/1978 009Labeling Revision  
4/25/1978 008Labeling Revision  
11/2/1976 004Labeling Revision  
9/22/1976 003Control Supplement  
11/5/1975 001Labeling Revision  
2/6/1975 000Approval Review 
 
Therapeutic Equivalents
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