Visitor Monitoring Drug History: XOPENEX
 
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: XOPENEX
FDA Application No: (NDA) 020837
Active Ingredient(s): LEVALBUTEROL HYDROCHLORIDE
Company: SEPRACOR
 
Label History
 
View the label approved on January 30, 2002 for XOPENEX, (NDA) 020837


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
9/7/2006 020Labeling Revision Letter 
7/18/2003 010Control Supplement Letter
Review 
8/7/2002 008Control Supplement  
3/4/2002 007Manufacturing Change or Addition  
1/30/2002 006Patient Population Altered Label 
2/16/2001 005Expiration Date Change  
12/4/2000 004Control Supplement  
4/12/2000 003Package Change  
9/21/1999 001Manufacturing Change or Addition  
3/25/1999 000Approval Letter
Label
Review
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