Visitor Monitoring Drug History: ENTOCORT EC
 
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: ENTOCORT EC
FDA Application No: (NDA) 021324
Active Ingredient(s): BUDESONIDE
Company: ASTRAZENECA
 
Label History
 
View the label approved on May 3, 2005 for ENTOCORT EC, (NDA) 021324


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
4/29/2005 005Patient Population Altered Letter
Label 
3/13/2003 004Manufacturing Change or Addition Letter 
10/3/2002 003Control Supplement Letter 
8/14/2002 002Expiration Date Change  
8/9/2002 001Control Supplement Letter 
10/2/2001 000Approval Letter
Label
Review
Patient Package Insert 
 
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