Visitor Monitoring Drug History: SOTALOL HYDROCHLORIDE
 
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Label and Approval History

Drug Name: SOTALOL HYDROCHLORIDE
FDA Application No: (ANDA) 075429
Active Ingredient(s): SOTALOL HYDROCHLORIDE
Company: TEVA
 
Label History
 
View the label approved on June 17, 2004 for SOTALOL HYDROCHLORIDE, (ANDA) 075429


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
12/3/2002 002Labeling  
10/13/2000 001Labeling  
5/1/2000 000Approval Letter
Letter
Label
Review 
7/20/1999 000Tentative Approval Letter
Letter
Label
Review 
11/16/1999 000Tentative Approval Letter
Letter
Label
Review 
 
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