Visitor Monitoring Drug History: PEMOLINE
 
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Label and Approval History

Drug Name: PEMOLINE
FDA Application No: (ANDA) 075030
Active Ingredient(s): PEMOLINE
Company: TEVA PHARMS
 
Label History
 
Labels are not available on this site for PEMOLINE, (ANDA) 075030
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
12/7/2000 013Facility Addition  
12/7/2000 012Facility Addition  
12/7/2000 011Facility Addition  
2/22/2000 010Labeling  
2/22/2000 009Packaging Addition  
2/22/2000 008Chemistry New Strength  
8/13/1999 007Labeling  
6/11/1999 006Chemistry  
6/11/1999 005Chemistry  
6/11/1999 001Chemistry  
1/29/1999 000Approval Letter 
 
Therapeutic Equivalents
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