Visitor Monitoring Drug History: ACETYLCYSTEINE
 
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Label and Approval History

Drug Name: ACETYLCYSTEINE
FDA Application No: (ANDA) 072621
Active Ingredient(s): ACETYLCYSTEINE
Company: ROXANE
 
Label History
 
Labels are not available on this site for ACETYLCYSTEINE, (ANDA) 072621
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
8/28/2000 005Facility Addition  
5/27/1999 004Labeling  
4/13/1998 003Chemistry  
4/13/1998 002Chemistry  
8/28/1996 001Chemistry  
9/30/1992 000Approval  
 
Therapeutic Equivalents
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