Visitor Monitoring Drug History: IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
 
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Label and Approval History

Drug Name: IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
FDA Application No: (ANDA) 075588
Active Ingredient(s): IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Company: LEINER
 
Label History
 
View the label approved on December 24, 2003 for IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, (ANDA) 075588


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
10/9/2002 001Packager Addition  
4/8/2002 000Approval Letter
Letter
Label
Review 
4/17/2001 000Tentative Approval Letter
Letter
Label
Review 
 
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