Visitor Monitoring Drug History: REBETOL
 
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: REBETOL
FDA Application No: (NDA) 020903
Active Ingredient(s): RIBAVIRIN
Company: SCHERING PLOUGH RES
 
Label History
 
View the label approved on April 20, 2007 for REBETOL, (NDA) 020903


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
4/13/2007 039Labeling Revision Letter
Label 
8/25/2006 038Labeling Revision Letter
Label 
6/24/2004 034Labeling Revision Letter
Label 
6/8/2004 033Labeling Revision Letter
Label 
10/10/2003 032Labeling Revision Letter
Label 
7/9/2003 030Labeling Revision Letter
Label 
5/21/2003 029Labeling Revision Letter
Label 
6/9/2003 028Labeling Revision Letter
Label 
12/20/2002 027Control Supplement  
11/13/2002 025Labeling Revision Letter
Label
Medication Guide 
11/13/2002 024Labeling Revision  
9/3/2002 023Labeling Revision Letter
Label 
1/3/2002 021Control Supplement  
3/6/2002 020Labeling Revision Letter
Review 
8/29/2001 019Control Supplement  
11/5/2001 017Control Supplement  
7/25/2001 016Labeling Revision Letter
Label
Review 
2/21/2002 015Labeling Revision Letter 
10/24/2001 014Labeling Revision Label 
12/28/2001 013Efficacy Supplement with Clinical Data to Support Letter
Label 
7/25/2001 012Labeling Revision Letter
Label
Review 
7/25/2001 011Labeling Revision Letter
Label
Review 
10/31/2001 010Labeling Revision Label 
7/25/2001 008Labeling Revision Letter
Label
Review 
3/13/2001 007Labeling Revision Letter
Review 
3/13/2001 006Labeling Revision Letter
Review 
2/23/2001 005Labeling Revision Label 
12/18/2000 004Labeling Revision  
3/2/2000 003Package Change  
12/9/1998 002Labeling Revision Letter
Label 
12/9/1998 001Patient Population Altered Letter
Label 
6/3/1998 000Approval Letter
Label
Review
Medication Guide 
 
There are no Therapeutic Equivalents
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