Visitor Monitoring Drug History: VENTOLIN ROTACAPS
 
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Label and Approval History

Drug Name: VENTOLIN ROTACAPS
FDA Application No: (NDA) 019489
Active Ingredient(s): ALBUTEROL SULFATE
Company: GLAXOSMITHKLINE
 
Label History
 
Labels are not available on this site for VENTOLIN ROTACAPS, (NDA) 019489
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
6/30/1999 019Manufacturing Change or Addition  
7/30/1998 018Labeling Revision  
12/26/1996 016Manufacturing Change or Addition  
1/26/1995 013Control Supplement  
6/14/1994 012Labeling Revision  
1/27/1994 011Labeling Revision  
8/18/1993 010Manufacturing Change or Addition  
7/20/1993 008Patient Population Altered  
10/28/1992 007Labeling Revision  
5/21/1992 006Labeling Revision  
4/6/1992 005Control Supplement  
12/15/1992 003Package Change  
9/24/1990 002Labeling Revision  
9/24/1990 001Patient Population Altered  
5/4/1988 000Approval  
 
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