Visitor Monitoring Drug History: AMIODARONE HYDROCHLORIDE
 
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Label and Approval History

Drug Name: AMIODARONE HYDROCHLORIDE
FDA Application No: (ANDA) 075315
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
Company: SANDOZ
 
Label History
 
Labels are not available on this site for AMIODARONE HYDROCHLORIDE, (ANDA) 075315
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
8/26/2002 009Labeling  
5/8/2002 008Control Supplement  
5/8/2002 007Facility Addition Letter 
1/11/2000 006Labeling Letter 
6/30/2000 005Labeling Letter 
6/30/2000 004Chemistry New Strength Letter 
2/2/2000 002Facility Addition  
7/21/1999 001Labeling  
12/23/1998 000Approval Letter
Review
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