Visitor Monitoring Drug History: PROAIR HFA
 
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Label and Approval History

Drug Name: PROAIR HFA
FDA Application No: (NDA) 021457
Active Ingredient(s): ALBUTEROL SULFATE
Company: IVAX RES LLC
 
Label History
 
View the label approved on November 30, 2005 for PROAIR HFA, (NDA) 021457


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
11/21/2005 004Labeling Revision Letter
Label 
2/3/2006 003New or Modified Indication Label
Exclusivity Letter 
11/21/2005 002Labeling Revision Letter
Label 
5/2/2005 001Control Supplement Letter
Label 
10/29/2004 000Approval Letter
Label
Review 
 
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