Visitor Monitoring Drug History: PACERONE
 
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Label and Approval History

Drug Name: PACERONE
FDA Application No: (ANDA) 075135
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
Company: UPSHER SMITH
 
Label History
 
View the label approved on April 30, 1998 for PACERONE, (ANDA) 075135


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
12/19/2002 009Facility Addition  
8/20/2002 008Labeling  
4/12/2000 007Labeling Review 
4/12/2000 006Manufacturing Revision Review 
4/12/2000 005Facility Addition Review 
2/1/2000 004SBA Letter
Review 
9/24/1999 003Labeling Letter
Review 
12/2/1999 002Facility Addition Letter
Review 
12/2/1999 001Chemistry Letter
Review 
4/30/1998 000Approval Letter
Label
Review
Other Important Information from FDA 
 
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